(403 days)
Wortham Laboratories Stasis 1 Coagulation Control (Normal) is intended for use as a quality control to monitor the performance of Prothrombin Time (PT), Activated Partial Thromboplastin Time (APTT) and Fibrinogen assays. It will yield PT, APTT, and Fibrinogen values in the normal range.
Wortham Laboratories Stasis 2 Coagulation Control (Abnormal) is intended for use as a quality control to monitor the performance of Prothrombin Time (PT), Activated Partial Thromboplastin Time (APTT). It will yield PT, and APTT values in the moderate abnormal range.
Wortham Laboratories Stasis 3 Coagulation Control (Abnormal) is intended for use as a quality control to monitor the performance of Prothrombin Time (PT), Activated Partial Thromboplastin Time (APTT). It will yield PT, and APTT values in the strongly abnormal range.
Wortham Laboratories Serathan-B PT reagent is an in-vitro diagnostic reagent intended in a clinical laboratory for the quantitative determination of Prothrombin Time (PT) testing for the detection of coagulation abnormalities in the extrinsic pathway. Serathan-B is a moderately sensitive thromboplastin reagent.
Wortham Laboratories Serathan-A PT reagent is an in-vitro diagnostic reagent intended in a clinical laboratory for the quantitative determination of Prothrombin Time (PT) testing for the detection of coagulation abnormalities in the extrinsic pathway. Serathan-A is a highly sensitive thromboplastin reagent.
Wortham Laboratories Intrin-EA APTT is an in-vitro diagnostic reagent used in the clinical laboratory for the quantitative determination of Activated Partial Thromboplastin Time (APTT) testing for the detection of coagulation abnormalities in the intrinsic pathway. Intrin-EA reagent is sensitive to mild coagulopathies.
Wortham Laboratories Intrin-SI is an in-vitro diagnostic reagent used in the clinical laboratory for the quantitative determination of Activated Partial Thromboplastin Time (APTT) testing for the detection of coagulation abnormalities in the intrinsic pathway. Intrin-SI reagent is sensitive to heparin and lupus anticoagulant plasmas.
Wortham Laboratories Fibrinogen Control Low, a quantitative control plasma, is intended for use in the quality control of fibrinogen assays.
Wortham Laboratories Fibrinogen Control Normal, a quantitative control plasma, is intended for use in the quality control of fibrinogen assays.
Wortham Laboratories Thrombin Reagent is intended for thrombin to convert fibrinogen in the quantitative determination of fibrinogen in plasma samples.
Wortham Laboratories Fibrinogen Assay Set, containing a complete set of Normal Fibrinogen Control (200-400 mg/dl), Thrombin Reagent (100 IU/ml), and Fibrinogen Buffer, is intend for use in the quantitative determination of fibrinogen in plasma samples.
Wortham Laboratories Heparin Control Level 1, is intended as a quality control of the Activated Partial Thromboplastin Time (APTT) during heparin monitoring.
Wortham Laboratories Heparin Control Level 2, is intended as a quality control of the Activated Partial Thromboplastin Time (APTT) during heparin monitoring.
Wortham Laboratories Calcium Chloride Solution 0.02 M (CaCl2) is intended for quantitative use with ellagic acid (Intrin-EA) or silicon particulate activators (Intrin-SI) in performing the activated partial thromboplastin time (APTT) on citrated plasma.
Wortham Laboratories Fibrinogen Buffer is designed as a diluent for fibrinogen studies.
Wortham Laboratories Stasis 1 Coagulation Control (Normal) is a liquid stable citrated plasma obtained from healthy donors. Stabilizers and buffers have been added to the plasma. Each unit of source material used in the preparation of the control has been tested by an FDA approved method and found to be non-reactive for HBsAg and negative for antibodies to HIV and HCV.
Wortham Laboratories Stasis 2 Coagulation Control (Abnormal) is a liquid stable citrated plasma obtained from healthy donors. Stabilizers and buffers have been added to the plasma. Each unit of source material used in the preparation of the control has been tested by an FDA approved method and found to be non-reactive for HBSAg and negative for antibodies to HIV and HCV.
Wortham Laboratories Stasis 3 Coagulation Control (Abnormal) is a liquid stable citrated plasma obtained from healthy donors. Stabilizers and buffers have been added to the plasma. Each unit of source material used in the preparation of the control has been tested by an FDA approved method and found to be non-reactive for HBsAg and negative for antibodies to HIV and HCV.
Wortham Laboratories Serathan-B PT Reagent is a liquid stable extract of rabbit thromboplastin containing calcium, stabilizer and buffer. Serathan-B is an in-vitro diagnostic reagent intended for use for the performance of Prothrombin Time (PT) testing and quantitative PT-based factor assays for Factors II, V. VII and X.
Wortham Laboratories Scrathan-A PT Reagent is a liquid stable extract of rabbit thromboplastin containing calcium, stabilizer and buffer. Serathan-A is an in-vitro diagnostic reagent intended for use for the performance of Prothrombin Time (PT) testing and quantitative PT-based factor assays for Factors II, V. VII and X.
Wortham Laboratories Intrin-EA APTT reagent is intended for use in determining activated partial thromboplastin time (APTT) and coagulation factor assays that are based on a modified APTT. The capacity of blood to form a fibrin clot by way of the intrinsic hemostatic pathway requires coagulation factors XII, XI, IX, VIII, platelet lipids and calcium. The assay is performed by the addition of a suspension of rabbit cephalin with the surface activator ellagic acid.
Wortham Laboratories Intrin-SI APTT Reagent is a liquid stable extract of rabbit brain thromboplastin, containing stabilizers and buffers. Intrin-SI is an in-vitro diagnostic reagent intended for use for the performance of a citrated Partial Thromboplastin Time (APTT) testing and quantitative PTT-based factor assays for Factors XII, XI, IX and VIII.
Wortham Laboratories Fibrinogen Low Control is a liquid stable preparation of citrated plasma obtained from healthy donors, which contains stabilizers and buffers. Each unit of source material used in the preparation of the control has been tested by an FDA approved method and found non-reactive for HBsAg and negative for antibodies to HIV and HCV.
Wortham Laboratories Fibrinogen Normal Control is a liquid stable preparation of citrated plasma obtained from healthy donors, which contains stabilizers and buffers. Each unit of source material used in the preparation of the control has been tested by an FDA approved method and found non-reactive for HBsAg and negative for antibodies to HIV and HCV.
Wortham Laboratories Thrombin Reagent is a liquid stable preparation of activated bovine proteins (Factor IIa).
Wortham Laboratories Fibrinogen Assay Set contains a liquid stable preparation of citrated plasma obtained from healthy donors, which contains stabilizers, buffers, and a bovine reagent and buffer solution which are also provided in the set. Each unit of source material used in the preparation of the control has been tested by an EDA approved method and found non-reactive for HBsAg and negative for antibodies to HIV and HCV.
Wortham Laboratories Heparin Control Level 1 is a liquid stable preparation of citrated plasma obtained from healthy donors, which contains sodium heparin, stabilizers and buffers. Each unit of source material used in the preparation of the control has been tested by an FDA approved method and found non-reactive for HBsAg and negative for antibodies to HIV and HCV.
Wortham Laboratories Heparin Control Level 2 is a liquid stable preparation of citrated plasma obtained from healthy donors, which contains sodium heparin, stabilizers and buffers. Each unit of source material used in the preparation of the control has been tested by an FDA approved method and found non-reactive for HBsAg and negative for antibodics to HIV and HCV.
Wortham Laboratories Calcium Chloride Solution 0.02 M (CaCl2) is intended for quantitative use with ellagic acid (Intrin-EA) or silicon particulate activators (Intrin-SI) in performing the activated partial thromboplastin time (APTT) on citrated plasma.
Fibrinogen Buffer : 1.3% TAPSO Buffer. 0.9% sodium chloride, 0.1% sodium azide and stabilizers; pH 7.35 ± 0.05.
The provided text describes 12 distinct devices from Wortham Laboratories, each with its own acceptance criteria and study findings. Due to the volume, I will provide a detailed breakdown for the first device, Stasis 1 Coagulation Control (Normal), and then summarize the general approach for the others as they follow a similar pattern.
Device: Wortham Laboratories Stasis 1 Coagulation Control (Normal)
1. Acceptance Criteria and Reported Device Performance:
The acceptance criteria for Wortham Laboratories Stasis 1 Coagulation Control (Normal) are implicitly established by demonstrating comparable or superior performance to the predicate device, Pacific Hemostasis Coagulation Control Level I. The reported device performance is presented in terms of Coefficient of Variation (CV%) for precision.
| Characteristic | Acceptance Criteria (Predicate: Pacific Hemostasis Coagulation Control Level I) | Reported Device Performance (New Device: Wortham Laboratories Stasis 1) |
|---|---|---|
| Intended Use | Routine coagulation for PT, PTT, fibrinogen assays in the normal range | Routine coagulation for PT, PTT, fibrinogen assays in the normal range |
| Control Composition | Lyophilized human citrated plasma | Liquid Human citrated plasma |
| Stability | 35 months @ 2-8° C (lyophilized), 8 hours @ 2-8° C (rehydrated) | 12 months @ ≤ -2° C, 30 days @ 2-4° C |
| CV% PT (within-run, ISI=1.54) | 0.90% | 0.75% |
| CV% PT (within-run, ISI=1.20) | 1.40% | 0.88% |
| CV% PT (run-run, ISI=1.54) | 0.85% | 0.67% |
| CV% PT (run-run, ISI=1.20) | 1.38% | 0.89% |
| CV% APTT (within-run, Kaolin) | 1.54% | 0.63% |
| CV% APTT (within-run, Ellagic-Acid) | 0.85% | 0.62% |
| CV% APTT (run-run, Kaolin) | 1.20% | 0.61% |
| CV% APTT (run-run, Ellagic Acid) | 0.85% | 0.60% |
| CV% Fibrinogen (within-run) | 0.59% | 0.56% |
| CV% Fibrinogen (run-run) | 0.60% | 0.57% |
| Expected Range PT | 11.66 sec (11.4-11.9 sec) | 11.67 sec (11.5-11.8 sec) |
| Expected Range APTT | 28.38 sec (28.0-28.8 sec) | 29.51 sec (29.3-29.7 sec) |
| Expected Range Fibrinogen | 306.3 g/dl (297-315 g/dl) | 306.3 g/dl (301-313 g/dl) |
| Storage | 2 - 8° C | ≤ -2° C |
| Assay Factors | PT, APTT, Fibrinogen | PT, APTT, Fibrinogen |
| Reproducibilty (Overall CV%) | Within-run: 1.36%, Run-run: (not explicitly stated, but derived from above data) | Within-run: 0.86%, Run-run: 0.89% |
Note: The acceptance criteria are "performance equal to or better than the predicate" for most quantitative metrics, and "same" for qualitative metrics like intended use and assay factors. The tables above directly compare the new device's performance to the predicate's stated performance, indicating the new device met or exceeded the predicate's precision values.
2. Sample size used for the test set and the data provenance:
The document mentions "Mechanical assays of Stasis 1 to the predicate normal plasma control" and "Mechanical measurements of the APTT in both Stasis 1 and Pacific Hemostasis Level 1 Control," along with "The processing of the Fibrinogen levels in both study graphs."
- Sample size: Not explicitly stated as a number of individual samples or runs for the test set. The data is presented as statistical measures (standard deviation, CV%) which are derived from a series of measurements, implying repeated testing.
- Data provenance: Not explicitly stated. The context suggests that the testing was performed by Wortham Laboratories, likely internally. It does not provide information about the country of origin of the data or if it was retrospective or prospective. The source material for the control is "liquid stable citrated plasma obtained from healthy donors," but this refers to the control product itself, not the clinical data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided. The "ground truth" for this device appears to be the quantitative measurements obtained from the predicate device (Pacific Hemostasis Coagulation Control Level I) and the established ranges for PT, APTT, and Fibrinogen in normal plasma. The comparison is against established quantitative performance metrics of a legally marketed predicate, not against expert consensus on a clinical outcome.
4. Adjudication method for the test set:
Not applicable. This is a comparison of quantitative laboratory performance metrics of a new control product against an existing predicate control. There is no human adjudication of diagnostic outcomes involved.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. This is a medical device for in-vitro diagnostic quality control, not an AI-assisted diagnostic tool interpreted by human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is a quality control product, not an algorithm. Its performance is measured directly by laboratory instruments (e.g., fibrometer).
7. The type of ground truth used:
The ground truth or reference standard for comparison is the performance characteristics of a legally marketed predicate device (Pacific Hemostasis Coagulation Control Level I). The "Expected Range" values are based on "Mechanical Mean ± 2SD," implying statistically derived ranges from repeated measurements, rather than pathology, expert consensus on images, or true outcomes data for individual patients.
8. The sample size for the training set:
Not applicable. This device is a quality control product, not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established:
Not applicable, as there is no training set for this type of device.
Summary for other devices (Stasis 2, Stasis 3, Serathan-B PT Reagent, Serathan-A PT Reagent, Intrin-EA APTT Reagent, Intrin-SI APTT Reagent, Fibrinogen Control Plasma (Low), Fibrinogen Control Plasma (Normal), Thrombin Reagent, Fibrinogen Assay Set, Heparin Control Plasma Level 1, Heparin Control Plasma Level 2, Calcium Chloride Solution 0.02 M, Fibrinogen Buffer):
All other devices described in the document (Stasis 2, Stasis 3, Serathan-B, Serathan-A, Intrin-EA, Intrin-SI, Fibrinogen Controls, Thrombin Reagent, Fibrinogen Assay Set, Heparin Controls, Calcium Chloride Solution, Fibrinogen Buffer) follow a very similar pattern to Stasis 1 Coagulation Control.
- Acceptance Criteria and Reported Device Performance: This is consistently established by comparing the new device's performance metrics (primarily Coefficient of Variation (CV%) and standard deviation (SD) for precision, and expected ranges) directly against a specific predicate device's reported performance. The new device consistently demonstrates comparable or improved precision compared to its respective predicate.
- Sample Size for Test Set, Data Provenance, Number of Experts, Adjudication Method, MRMC Studies, Standalone Performance, Ground Truth Type, Training Set Size, and Training Set Ground Truth:
- Sample Size: Not explicitly stated as the number of individual tests or samples; reported as statistical measures (SD, CV%) derived from repeated measurements.
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). Implied internal testing by Wortham Laboratories.
- Experts/Adjudication/MRMC/Standalone: Not applicable to these types of in-vitro diagnostic quality control and reagent products, as they are evaluated based on quantitative laboratory performance against chemical/biological standards or predicate product performance, not human diagnostic interpretation.
- Ground Truth Type: For all these devices, the ground truth for evaluation is the established performance characteristics of the legally marketed predicate device, as well as the expected physiological/clinical ranges for the assays they control or participate in (e.g., normal/abnormal PT/APTT/Fibrinogen values).
- Training Set: Not applicable, as these are not AI/ML algorithms.
The overall conclusion for all devices is a claim of "substantial equivalence" to their respective predicates based on comparable intended use, technological characteristics, and performance data consistently showing competitive or superior precision and expected ranges.
{0}------------------------------------------------
MAY 15 2007
Premarket Notification 510 (k) Summary
Stasis 1 Coagulation Control
The assigned 510K number is: K060968
| Applicant: | Wortham Laboratories, Inc.6340 Bonny Oaks DrChattanooga, TN 37416Tel: (423) 296-0090Fax: (423) 296-0188 |
|---|---|
| Contact: | Leon Wortham |
| Date: | April 6, 2007 |
| Device Name: | Wortham Laboratories Stasis 1 Coagulation Control (Normal) |
| Common Name: | Normal Coagulation Control |
| Classification Name: | Plasma, Coagulation Control, a class II device as per 21 CFR section 864.5425(Product Code GGC). This device is intended for clinical usein conjunction with an analyzer to measure clot formation. |
| Predicate: | Pacific Hemostasis Coagulation Control Level I (K984129) |
Description
Wortham Laboratories Stasis 1 Coagulation Control (Normal) is a liquid stable citrated plasma obtained from healthy donors. Stabilizers and buffers have been added to the plasma. Each unit of source material used in the preparation of the control has been tested by an FDA approved method and found to be non-reactive for HBsAg and negative for antibodies to HIV and HCV.
Intended Use
Wortham Laboratories Stasis 1 Coagulation Control (Normal) is intended for use as a quality control to monitor the performance of Prothrombin Time (PT), Activated Partial Thromboplastin Time (APTT) and Fibrinogen assays. It will yicld PT, APTT, and Fibrinogen values in the normal range.
Labeling
{1}------------------------------------------------
| CharacteristicsIntended Use | New Device | Predicate |
|---|---|---|
| Routine coagulation for PT, PTT, fibrinogen assays in the normal range | Routine coagulation for PT, PTT, fibrinogen assays in the normal range | |
| ControlComposition | Liquid Human citrated plasma | Lypholyzed human citrated plasma |
| Stability | 12 months @≤ -2° C30 days @ 2-4° С | 35 months @ 2-8° C, lypholyzed8 hours @ 2-8° C, rehydrated |
| ReferenceValues | CV% PT | CV% PT |
| within-run (ISI=1.54) 0.75% | within-run (ISI=1.54) 0.90% | |
| within-run (ISI=1.20) 0.88% | within-run (ISI=1.20) 1.40% | |
| run-run (ISI=1.54) 0.67% | run-run (ISI=1.54) 0.85% | |
| run-run (ISI=1.20) 0.89% | run-run (ISI=1.20) 1.38% | |
| CV% APTT | CV% APTT | |
| within-run (Kaolin) 0.63% | within-run (Kaolin) 1.54% | |
| within-run (Ellagic-Acid) 0.62% | within-run (Ellagic-Acid) 0.85% | |
| run-run (Kaolin) 0.61% | run-run (Kaolin) 1.20% | |
| run-run (Ellagic Acid) 0.60% | run-run (Ellagic Acid) 0.85% | |
| CV% Fibrinogen | CV% Fibrinogen | |
| within-run 0.56% | within-run 0.59% | |
| run-run 0.57% | run-run 0.60% | |
| Expected Range | Mechanical Mean ± 2SD | Mechanical Mean ± 2SD |
| PT 11.67 11.5-11.8 sec | PT 11.66 11.4-11.9 sec | |
| APTT: 29.51 29.3-29.7 sec | APTT: 28.38 28.0-28.8 sec | |
| Fibrinogen: 306.3 301-313 g/dl | Fibrinogen: 306.3 297-315 g/dl | |
| Storage | ≤ -2° C | 2 - 8° C |
| Assay Factors | PT, APTT, Fibrinogen | PT, APTT, Fibrinogen |
:
·
{2}------------------------------------------------
Conclusions
Stasis 1
Wortham Laboratories Stasis 1 and Pacific Hemostasis Coagulation Control Level I have the same intended use, as normal controls for the quantitative measurement of the (PT), Activated Partial Thromboplastin Time (APTT) and fibrinogen levels. Both are preparations of citrated plasma obtained from normal donors with added stabilizers and buffers.
Mechanical assays of Stasis 1 to the predicate normal plasma control with two different sensitive thromboplastin reagents, with an ISI of 1.20 and 1.58, yielded a within-run standard deviation of 0.0809 and 0.0922 for Stasis 1 respectively, compared to a 0.1714 and a 0.1050 SD for the predicate control from the same reagents. A run-run precision of Stasis 1 produced a 0.1026 and 0.0784 SD with the two thromboplastin reagents, compared to 0.1733 and 0.0987 SD of Pacific Hemostasis Control.
Mechanical measurements of the APTT in both Stasis 1 and Pacific Hemostasis Level 1 Control with two different activator reagents, Kaolin and ellagic acid, produced a within-run 0.0863 and a 0.1792 standard deviation, respectively, while the predicate control vielded a 0.1989 and a 0.2455 SD. A run-run precision of the Stasis 1 Control measured at 0.1705 and 0.1749 SD to the two APTT activators, contrasted to Pacific Hemostasis Level I Controls 0.3339 and 0.2453 SD.
The processing of the Fibrinogen levels in both study graphs on the fibrometer instrument produced a within-run 0.0850 and a 0.0858 run-run standard deviation for Stasis 1, which a within-run 0.089 SD and run-run 0.0900 SD was observed in the Pacific Hemostasis Level 1 Control.
Reproducibility of the two controls yielded a 0.86% within-run coefficient of variation and a run-run 0.89% CV for Stasis 1, compared respectively to the predicate control of 1.36% CV.
The performance data presented here, as well as the undistinguishable intended use and technological characteristics support the substantial equivalence claim for Wortham Laboratories Stasis 1 Coagulation Control to Pacific Hemostasis Coagulation Control Level I. Based on the data provided, it is our conclusion that these two products are substantially equivalent.
{3}------------------------------------------------
K0609868
MAY 15 2007
Premarket Notification 510 (k) Summary
Stasis 2 Coagulation Control
The assigned 510K number is: K060968
| Applicant: | Wortham Laboratories, Inc.6340 Bonny Oaks DrChattanooga, TN 37416Tel: (423) 296-0090Fax: (423) 296-0188 |
|---|---|
| Contact: | Leon Wortham |
| Date: | April 6, 2007 |
| Device Name: | Wortham Laboratories Stasis 2 Coagulation Control (Abnormal) |
| Common Name: | Abnormal Coagulation Control |
| Classification Name: | Plasma, Coagulation Control, a class II device as per 21 CFR section 864.5425(Product Code GGC). This device is intended for clinical usein conjunction with an analyzer to measure clot formation. |
| Predicate: | Pacific Hemostasis Coagulation Control Level II (K984130) |
Description
Wortham Laboratories Stasis 2 Coagulation Control (Abnormal) is a liquid stable citrated plasma obtained from healthy donors. Stabilizers and buffers have been added to the plasma. Each unit of source material used in the preparation of the control has been tested by an FDA approved method and found to be non-reactive for HBSAg and negative for antibodies to HIV and HCV.
Intended Use
Wortham Laboratories Stasis 2 Coagulation Control (Abnormal) is intended for use as a quality control to monitor the performance of Prothrombin Time (PT), Activated Partial Thromboplastin Time (APTT). It will yield PT, and APTT values in the moderate abnormal range.
Labeling
{4}------------------------------------------------
| CharacteristicsIntended Use | New DeviceRoutine coagulation for PT, PTT, assays in themoderately abnormal range | PredicateRoutine coagulation for PT, PTT, assays inthe moderately abnormal range | |||||
|---|---|---|---|---|---|---|---|
| ControlComposition | Liquid Human citrated plasma | Lypholyzed human citrated plasma | |||||
| Stability | 12 months @ ≤ -2° C30 days @ 2-4° C | 34 months @ 2-8° C, lypholyzed8 hours @ 2-8° C, rehydrated | |||||
| ReferenceValues | CV% | PT | CV% | PT | |||
| within-run (ISI=1.54) | 1.01% | within-run (ISI=1.54) | 1.41% | ||||
| within-run (ISI=1.20) | 1.10% | within-run (ISI=1.20) | 1.28% | ||||
| run-run (ISI=1.54) | 0.98% | run-run (ISI=1.54) | 1.30% | ||||
| run-run (ISI=1.20) | 1.01% | run-run (ISI=1.20) | 1.19% | ||||
| CV% | APTT | CV% | APTT | ||||
| within-run (Kaolin) | 0.76% | within-run (Kaolin) | 1.00% | ||||
| within-run (Ellagic-Acid) | 0.50% | within-run (Ellagic-Acid) | 0.91% | ||||
| run-run (Kaolin) | 0.76% | run-run (Kaolin) | 1.06% | ||||
| run-run (Ellagic Acid) | 0.48% | run-run (Ellagic Acid) | 0.90% | ||||
| Expected Range | Mechanical | Mean | + 2SD | Mechanical | Mean | + 2SD | |
| PT | 20.14 | 19.9-20.3 sec | PT | 20.25 | 19.7-20.8 sec | ||
| APTT: | 55.75 | 54.9-56.6 sec | APTT: | 55.01 | 53.9-56.2 sec | ||
| Storage | ≤ -2° C | 2 - 8° C | |||||
| Assay Factors | PT, APTT | PT, APTT |
:
.
{5}------------------------------------------------
Conclusions
Stasis 2
Wortham Laboratories Stasis 2 and Pacific Hemostasis Coagulation Control Level II have the same intended use, as normal controls for the quantitative measurement of the Prothrombin Time (PT). Activated Partial Thromboolastin Time (APTT). Both are preparations of citrated plasma obtained from normal donors with added stabilizers and buffers.
Mechanical assays of Stasis 2 to the predicate moderately abnormal with two different sensitive thromboplastin reagents, 1.20 ISI and 1.58 ISI, yielded a standard deviation of 0.5992 and 0.2023 for Stasis 2 respectively, compared to a 0.2856 SD for the predicate control from the same reagents. A run-run precision of Stasis 2 produced a 0.3664 and 0.1984 SD with the two thromboplastin reagents, compared to 0.4296 and 0.2644 SD of Pacific Hemostasis Control.
Mcchanical measurements of the APTT in both Stasis 2 and Pacific Hemostasis Level II Control with two different activator reagents, Kaolin and ellagic acid, produced a 0.4135 and a 0.2341 standard deviation, respectively, while the predicate control yielded a 0.5721 and a 0.4045 SD. A run-run precision of the Stasis 2 Control measured at 0.41 36 and 0.2233 SD to the two APTT activators, contrasted to Pacific Hemostasis Level II Controls 0.5628 and 0.4043 SD.
Reproducibility of the two controls yielded a 1.10% within-run coefficient of variation and a run-run 1.01% CV for Stasis 2, compared respectively to the predicate control of 1.28% CV and 1.19% CV.
The performance data presented here, as well as the undistinguishable intended use and technological characteristics support the substantial equivalence claim for Wortham Laboratories Stasis 2 Coagulation Control to Pacific Hemostasis Coagulation Control Level II. Based on the data provided, it is our conclusion that these two products are substantially equivalent.
{6}------------------------------------------------
Koco968
MAY 15 2007
Wortham Laboratories, Inc.
Premarket Notification 510 (k) Summary
Stasis 3 Coagulation Control
The assigned 510K number is: K060968
| Applicant: | Wortham Laboratories, Inc.6340 Bonny Oaks DrChattanooga, TN 37416Tel: (423) 296-0090Fax: (423) 296-0188 |
|---|---|
| Contact: | Leon Wortham |
| Date: | April 6, 2007 |
| Device Name: | Wortham Laboratories Stasis 3 Coagulation Control (Abnormal) |
| Common Name: | Abnormal Coagulation Control |
| Classification Name: | Plasma, Coagulation Control, a class II device as per 21 CFR section 864.5425(Product Code GGC). This device is intended for clinical usein conjunction with an analyzer to measure clot formation. |
| Predicate: | Pacific Hemostasis Coagulation Control Level III (K984131) |
Description
Wortham Laboratories Stasis 3 Coagulation Control (Abnormal) is a liquid stable citrated plasma obtained from healthy donors. Stabilizers and buffers have been added to the plasma. Each unit of source material used in the preparation of the control has been tested by an FDA approved method and found to be non-reactive for HBsAg and negative for antibodies to HIV and HCV.
Intended Use
Wortham Laboratories Stasis 3 Coagulation Control (Abnormal) is intended for use as a quality control to monitor the performance of Prothrombin Time (PT), Activated Partial Thromboplastin Time (APTT). It will yield PT, and APTT values in the strongly abnormal range.
Labeling
{7}------------------------------------------------
·
| Characteristics | New Device | Predicate | ||||||
|---|---|---|---|---|---|---|---|---|
| Intended Use | Routine coagulation for PT, PTT, assays in the high abnormal range | Routine coagulation for PT, PTT, assays in the high abnormal range | ||||||
| Control Composition | Liquid Human citrated plasma | Lypholyzed human citrated plasma | ||||||
| Stability | 12 months @ ≤ -2° C30 days @ 2-4° C | 35 months @ 2-8° C, lypholyzed8 hours @ 2-8° C, rehydrated | ||||||
| Reference Values | CV% | PT | CV% | PT | ||||
| within-run (ISI=1.54) | 1.45% | within-run (ISI=1.54) | 1.68% | |||||
| within-run (ISI=1.20) | 1.36% | within-run (ISI=1.20) | 1.52% | |||||
| run-run (ISI=1.54) | 1.46% | run-run (ISI=1.54) | 1.70% | |||||
| run-run (ISI=1.20) | 1.44% | run-run (ISI=1.20) | 1.34% | |||||
| CV% | APTT | CV% | APTT | |||||
| within-run (Kaolin) | 0.80% | within-run (Kaolin) | 1.12% | |||||
| within-run (Ellagic-Acid) | 0.76% | within-run (Ellagic-Acid) | 1.12% | |||||
| run-run (Kaolin) | 0.75% | run-run (Kaolin) | 1.15% | |||||
| run-run (Ellagic Acid) | 0.75% | run-run (Ellagic Acid) | 1.11% | |||||
| Expected Range | Mechanical | Mean | ± 2SD | Mechanical | Mean | ± 2SD | ||
| PT | 32.50 | 32.0-33.0 sec | PT | 32.49 | 31.4-33.6 sec | |||
| APTT: | 70.49 | 69.4-71.5 sec | APTT: | 70.13 | 68.8-71.4 sec | |||
| Storage | ≤ -2° C | 2 - 8° C | ||||||
| Assay Factors | PT, APTT | PT, APTT |
:
{8}------------------------------------------------
Conclusions
Stasis 3
Wortham Laboratories Stasis 3 and Pacific Hemostasis Coagulation Control Level III have the same intended use, as normal controls for the quantitative measurement of the Prothrombin Time (PT), Activated Partial Thromboplastin Time (APTT). Both are preparations of citrated plasma obtained from normal donors with added stabilizers and buffers.
Mechanical assays of Stasis 3 to the predicate moderately abnormal plasma control with two different sensitive thromboplastin reagents, 1.20 ISI and 1.58 ISI, yielded a standard deviation of 0.8385 and 0.4721 for Stasis 3 respectively, compared to a 0.9333 and a 0.5467 for the predicate control from the same reagents. A run-run precision of Stasis 3 produced a 0.841 and 0.4712 SD with the two thromboplastin reagents, compared to 0.9696 and 0.5512 SD of Pacific Hemostasis Control.
Mechanical measurements of the APTT in both Stasis 3 and Pacific Hemostasis Level III Control with two different activator reagents, Kaolin and ellagic acid, produced a 0.5278 and a 0.4928 standard deviation, respectively, while the predicate control vielded a 0.7160 SD. A run-run precision of the Stasis 3 Control measured at 0.5273 and 0.4860 SD to the two APTT activators, contrasted to Pacific Hemostasis Level III Controls 0.8029 and 0.7133 SD.
Reproducibility of the two controls yielded a 1.35% within-run coefficient of variation and a run-run 1.36% CV for Stasis 3, compared respectively to the predicate control of 1.52% CV.
The performance data presented here, as well as the undistinguishable intended use and technological characteristics support the substantial equivalence claim for Wortham Laboratories Stasis 3 Coagulation Control to Pacific Hemostasis Coagulation Control Level III. Based on the data provided, it is our conclusion that these two products are substantially equivalent.
{9}------------------------------------------------
Premarket Notification 510 (k) Summary
MAY 15 2007
Serathan-B PT Reagent
The assigned 510K number is: K060968
| Applicant: | Wortham Laboratories, Inc.6340 Bonny Oaks DrChattanooga, TN 37416Tel: (423) 296-0090Fax: (423) 296-0188 |
|---|---|
| Contact: | Leon Wortham |
| Date: | April 6, 2007 |
| Device Name: | Wortham Laboratories Serathan-B PT Reagent. |
| Common Name: | Prothrombin Time |
| Classification Name: | Prothrombin Time Test, is a class II device, as per 21 CFR 864.7750(Product Code GJS). This device is intended for clinical use in conjunction withan analyzer to measure clot formation. |
| Predicate: | Pacific Hemostasis Thromboplastin-D (K994100) |
Description
Wortham Laboratories Serathan-B PT Reagent is a liquid stable extract of rabbit thromboplastin containing calcium, stabilizer and buffer. Serathan-B is an in-vitro diagnostic reagent intended for use for the performance of Prothrombin Time (PT) testing and quantitative PT-based factor assays for Factors II, V. VII and X.
Intended Use
Wortham Laboratories Serathan-B PT reagent is an in-vitro diagnostic reagent intended in a clinical laboratory for the quantitative determination of Prothrombin Time (PT) testing for the detection of coagulation abnormalities in the extrinsic pathway. Serathan-B is a moderately sensitive thromboplastin reagent.
Labeling
{10}------------------------------------------------
:
:
| CharacteristicsIntended Use | New DevicePerformance of Prothrombin Time (PT) testingfor the detection of coagulation abnormalities inthe extrinsic pathway | PredicatePerformance of Prothrombin Time (PT) testingfor the detection of coagulation abnormalities inthe extrinsic pathway | |||||||
|---|---|---|---|---|---|---|---|---|---|
| ReagentComposition | Liquid Rabbit Thromboplastin | Lypholyzed Rabbit Thromboplastin | |||||||
| Stability | 12 months @ ≤ -2° C30 days @ 2-4° C | 30 months @ 2-8° C, lypholyzed7 days @ 2-8° C, rehydrated | |||||||
| ReferenceValues | within-run | CV% | within-run | CV% | |||||
| Level 1 | 0.80% | Level 1 | 0.90% | ||||||
| Level 2 | 1.27% | Level 2 | 1.41% | ||||||
| Level 3 | 1.42% | Level 3 | 1.68% | ||||||
| run-run | CV% | run-run | CV% | ||||||
| Level 1 | 1.75% | Level 1 | 0.85% | ||||||
| Level 2 | 1.22% | Level 2 | 1.30% | ||||||
| Level 3 | 1.44% | Level 3 | 1.70% | ||||||
| Lupus Sensitivity | CV% | Lupus Sensitivity | CV% | ||||||
| 0.32% | 1.67% | ||||||||
| Factor Assay | CV% | Factor Assay | CV% | ||||||
| Factor II | 0.00% | Factor II | 0.39% | ||||||
| Factor V | 0.26% | Factor V | 0.32% | ||||||
| Factor VII | 0.19% | Factor VII | 0.32% | ||||||
| Factor X | 0.19% | Factor X | 0.31% | ||||||
| ExpectedRange | Mean (sec) | Mean (sec) | |||||||
| % | II | V | VII | X | II | V | VII | X | |
| 100 | 11.00 | 11.49 | 11.40 | 11.60 | 10.88 | 11.38 | 11.28 | 11.48 | |
| 50 | 11.01 | 11.89 | 12.41 | 11.39 | 10.88 | 11.80 | 12.32 | 13.13 | |
| 40 | 11.49 | 12.41 | 13.09 | 13.82 | 11.41 | 12.29 | 12.92 | 13.56 | |
| 30 | 11.79 | 13.19 | 13.90 | 14.91 | 11.70 | 13.00 | 13.71 | 14.73 | |
| 20 | 12.30 | 14.70 | 14.79 | 16.32 | 12.22 | 14.50 | 14.50 | 16.08 | |
| 10 | 13.71 | 17.12 | 16.48 | 20.02 | 13.63 | 16.93 | 16.17 | 19.81 | |
| Linearity | 11.6 - 36.2 sec | 11.1 - 35.6 sec | |||||||
| Storage | ≤ -2° C | 2 - 8° C | |||||||
| Assay Factors | PT, Fibrinogen, Factors | PT, Fibrinogen, Factors |
:
{11}------------------------------------------------
Conclusions
Serathan-B
Wortham Laboratories Serathan-B and Pacific Hemostasis Thromboplastin-D reagents have the same intended use, as for the quantitative measurement of the Prothrombin Time (PT), and Factors II, V, VII, X. Both reagents are preparations of rabbit thromboplastin and calcium chloride, with an International Sensitivity Index of 1.5 - 1.7.
All assays were measured on the fibrometer yielding a PT standard deviation of 0.0869, 0.2033 and 0.4721 for Scrathan-B on Level 1, Level 3, Level 3 plasma controls, respectively, compared to Pacific Hemostasis Thromboplastin-D of 0.1050, 0.2856, 0.5467 standard deviation on the same controls.
Comparing the precision of the two reagents in the factor assays produced a standard deviation of 0.03, 0.022 and 0.022 for Factors II, V, VII, X, respectively for Serathan-B, contrasted to 0.043, 0.036, and 0.036 for Thromboplastin-D.
Reproducibility of the two reagents yielded a 0.80% within-run coefficient of variation and a run-run 0.75% CV for Serathan-B, compared respectively to the predicate control of 0.91% CV and 0.89% CV.
The performance data presented here, as well as the undistinguishable intended use and technological characteristics support the substantial equivalence claim for Wortham Laboratories Serathan-B to Pacific Hemostasis Thromboplastin-D. Based on the data provided, it is our conclusion that these two products are substantially equivalent.
{12}------------------------------------------------
K0606768
Premarket Notification 510 (k) Summary
Serathan-A PT Reagent
MAY 15 2007
The assigned 510K number is: K060968
| Applicant: | Wortham Laboratories, Inc.6340 Bonny Oaks DrChattanooga, TN 37416Tel: (423) 296-0090Fax: (423) 296-0188 |
|---|---|
| Contact: | Leon Wortham |
| Date: | April 6, 2007 |
| Device Name: | Wortham Laboratories Serathan-A PT Reagent. |
| Common Name: | Prothrombin Time |
| Classification Name: | Prothrombin Time Test, is a class II device, as per 21 CFR 864.7750(Product Code GJS). This device is intended for clinical use in conjunction withan analyzer to measure clot formation. |
| Predicate: | Pacific Hemostasis Thromboplastin-DS (K940082) |
Description
Wortham Laboratories Scrathan-A PT Reagent is a liquid stable extract of rabbit thromboplastin containing calcium, stabilizer and buffer. Serathan-A is an in-vitro diagnostic reagent intended for use for the performance of Prothrombin Time (PT) testing and quantitative PT-based factor assays for Factors II, V. VII and X.
Intended Use
Wortham Laboratories Serathan-A PT reagent is an in-vitro diagnostic reagent intended in a clinical laboratory for the quantitative determination of Prothrombin Time (PT) testing for the detection of coagulation abnormalities in the extrinsic pathway. Serathan-A is a highly sensitive thromboplastin reagent.
Labeling
{13}------------------------------------------------
| CharacteristicsIntended Use | New DevicePerformance of Prothrombin Time (PT) testingfor the detection of coagulation abnormalities inthe extrinsic pathway | PredicatePerformance of Prothrombin Time (PT) testingfor the detection of coagulation abnormalities inthe extrinsic pathway |
|---|---|---|
| ReagentComposition | Liquid Rabbit Thromboplastin | Lypholyzed Rabbit Thromboplastin |
| Stability | 12 months @ ≤ -2° C30 days @ 2-4° C | 30 months @ 2-8° C, lypholyzed7 days @ 2-8° C, rehydrated |
| ReferenceValues | within-run | |
| CV% | ||
| Level 1 0.89%Level 2 1.09%Level 3 1.25% | Level 1 1.36%Level 2 1.28%Level 3 1.52% | |
| run-run | ||
| CV% | ||
| Level 1 0.88%Level 2 1.08%Level 3 1.28% | Level 1 1.38%Level 2 1.19%Level 3 1.58% | |
| Lupus Sensitivity | CV% | |
| 0.29% | 2.04% | |
| CV% | ||
| Factor Assay | Factor Assay | |
| Factor II 1.25%Factor V 0.25%Factor VII 0.25%Factor X 0.18% | Factor II 0.42%Factor V 0.37%Factor VII 0.38%Factor X 0.32% | |
| ExpectedRange | Mean (sec) | |
| % II V VII X | % II V VII X | |
| 100 | 11.79 11.79 11.99 11.90 | 11.69 11.67 11.90 11.80 |
| 50 | 11.80 13.41 12.79 13.11 | 11.72 13.31 12.70 12.98 |
| 40 | 12.02 14.20 12.98 13.60 | 11.92 14.09 12.92 13.51 |
| 30 | 12.38 15.20 13.82 14.52 | 12.30 15.13 13.72 14.38 |
| 20 | 12.99 16.29 14.11 15.21 | 12.80 16.22 14.02 15.10 |
| 10 | 14.31 18.66 15.51 17.52 | 14.02 18.48 15.38 17.30 |
| Linearity | 12.1 - 41.9 sec | 11.9 - 41.1 sec |
| Storage | ≤ -2° C | 2 - 8° C |
| Assay Factors | PT, Fibrinogen, FactorsII, V, VII, X | PT, Fibrinogen, FactorsII, V, VII, X |
.
ﺮ
{14}------------------------------------------------
Conclusions
Serathan-A
Wortham Laboratories Serathan-A and Pacific Hemostasis Thromboplastin-DS reagents have the same intended use, as for the quantitative measurement of the Prothrombin Time (PT), and Factors II, V, VII, X. Both reagents are preparations of rabbit thromboplastin and calcium chloride, with an International Sensitivity Index of 1.0 - 1.2.
All assays were measured on the fibrometer yiclding a PT standard deviation of 0.135, 0.3977 and 0.7746 for Serathan-A on Level 1, Level 2, Level 3 plasma controls, respectively, compared to Pacific Hemostasis Thromboplastin-DS of 0.1694, 0.4320, 0.8556 standard deviation on the same controls.
Comparing the precision of the two reagents in the factor assays produced a standard deviation of 0.030, 0.030, 0.030 and 0.022 for Factors II, V, VII, X, respectively for Serathan-A, contrasted to 0.0497, 0.043, and 0.038 for Thromboplastin-DS.
Reproducibility of the two reagents yielded a 1.09% within-run cocfficient of variation and a run-run 0.97% CV for Serathan-A, compared respectively to the predicate control of 1.18% CV.
The performance data presented here, as well as the undistinguishable intended use and technological characteristics support the substantial equivalence claim for Wortham Laboratories Serathan-A to Pacific Hemostasis Thromboplastin-DS. Based on the data provided, it is our conclusion that these two products are substantially equivalent.
{15}------------------------------------------------
1660968
MAY 15 2007
Premarket Notification 510 (k) Summary
Intrin-EA APTT Reagent
The assigned 510K number is: K060968
| Applicant: | Wortham Laboratories, Inc.6340 Bonny Oaks DrChattanooga, TN 37416Tel: (423) 296-0090Fax: (423) 296-0188 |
|---|---|
| Contact: | Leon Wortham |
| Date: | April 6, 2007 |
| Device Name: | Wortham Laboratories Intrin-EA APTT Reagent. |
| Common Name: | Activated Partial Thromboplastin Time (APTT) |
| Classification Name: | Activated Partial Thromboplastin is a class II device, as per 21 CFR 864.7925(Product Code GFO). This device is intended for clinical use in conjunctionwith an analyzer to measure clot formation. |
| Predicate: | Pacific Hemostasis APTT-LS (K891337) |
Description
Wortham Laboratories Intrin-EA APTT reagent is intended for use in determining activated partial thromboplastin time (APTT) and coagulation factor assays that are based on a modified APTT. The capacity of blood to form a fibrin clot by way of the intrinsic hemostatic pathway requires coagulation factors XII, XI, IX, VIII, platelet lipids and calcium. The assay is performed by the addition of a suspension of rabbit cephalin with the surface activator ellagic acid.
Intended Use
Wortham Laboratories Intrin-EA APTT is an in-vitro diagnostic reagent used in the clinical laboratory for the quantitative determination of Activated Partial Thromboplastin Time (APTT) testing for the detection of coagulation abnormalities in the intrinsic pathway. Intrin-EA reagent is sensitive to mild coagulopathies.
Labeling
{16}------------------------------------------------
| Substantial EquivalenceCharacteristics | New Device | Predicate | ||
|---|---|---|---|---|
| Intended Use | Performance of Activated PartialThromboplastin Time (APTT) testing for thedetection of coagulation abnormalities in theintrinsic pathway | Performance of Activated Partial ThromboplastinTime (APTT) testing for the detection ofcoagulation abnormalities in the intrinsic pathway | ||
| ReagentComposition | Liquid Rabbit Thromboplastin with ellagicacid activator | Liquid Rabbit Thromboplastin with ellagic acidactivator | ||
| Stability | 12 months @ ≤ -2° C30 days @ 2-4° С | 22 months @ 2-8° C, lypholyzed30 days @ 2-8° C, rehydrated | ||
| ReferenceValues | within-run | CV% | within-run | CV% |
| Level 1 | 0.51% | Level 1 | 0.85% | |
| Level 2 | 0.41% | Level 2 | 0.91% | |
| Level 3 | 0.73% | Level 3 | 1.12% | |
| run-run | CV% | run-run | CV% | |
| Level 1 | 0.51% | Level 1 | 0.85% | |
| Level 2 | 0.44% | Level 2 | 0.90% | |
| Level 3 | 0.71% | Level 3 | 1.11% | |
| Heparin Sensitivity | CV% | Heparin Sensitivity | CV% | |
| 0.25 U/ml | 0.71% | 0.25 U/ml | 1.03% | |
| 0.35 U/ml | 0.54% | 0.35 U/ml | 0.91% | |
| Lupus Sensitivity | CV% | Lupus Sensitivity | CV% | |
| 4.39% | 7.81% | |||
| Factor Assay | CV% | Factor Assay | CV% | |
| Factor VIII | 0.17% | Factor VIII | 0.23% | |
| Factor IX | 0.17% | Factor IX | 0.24% | |
| Factor XI | 0.14% | Factor XI | 0.29% | |
| Factor XII | 0.13% | Factor XII | 0.26% | |
| ExpectedRange | Mean (sec) | Mean (sec) | ||
| % | VIII | IX | XI | XII |
| 100 | 29.36 | 28.54 | 29.47 | 26.82 |
| 50 | 33.86 | 32.38 | 34.74 | 29.89 |
| 40 | 35.08 | 34.03 | 36.26 | 31.14 |
| 30 | 37.33 | 36.34 | 38.61 | 32.23 |
| 20 | 40.47 | 38.64 | 41.35 | 33.33 |
| 10 | 45.10 | 40.89 | 46.84 | 35.04 |
| 28.23 | 27.48 | 28.32 | 25.78 | |
| 32.57 | 31.26 | 33.36 | 28.65 | |
| 33.83 | 33.02 | 35.03 | 29.78 | |
| 36.13 | 35.12 | 37.30 | 31.09 | |
| 39.20 | 37.40 | 40.14 | 32.07 | |
| 43.78 | 39.86 | 45.70 | 33.21 | |
| Linearity | 29.0 - 70.7 sec | 28.5 - 69.6 sec | ||
| Storage | < -2° C | 2 - 8° C | ||
| Assay Factors | APTT, Heparin, Factors | APTT, Heparin, Factors |
:
{17}------------------------------------------------
Conclusions
Intrin-EA
Wortham Laboratories Intrin-EA and Pacific Hemostasis APTT-LS reagents have the same intended use, as for the quantitative measurement of the Activated Partial Thromboplastin Time (APTT), Heparin, and Factors VIII, IX, XI, XII. Both reagents are preparations of rabbit thromboplastin and ellagic acid as an activator.
All assays were measured on the fibrometer yielding an APTT standard deviation of 0.1483, 0.1968 for Intrin-EA on Level 1, Level 3 plasma controls, respectively, compared to Pacific Hemostasis APTT-LS of 0.1908, 0.4030, 0.8900 standard deviation on the same controls.
Intrin-EA sensitivity to heparin at 0.25 U/ml, yielded a 0.2236 standard deviation to both levels of heparin compared to 0.3078 and 0.3664 standard deviation, respectively, in the predicate product.
Comparing the precision of the two reagents in the factor assays produced a standard deviation of 0.049, 0.048, 0.043, and 0.036 SD for Factors VIII, IX, XI, XII, respectively for Intrin-EA, to 0.064, 0.065, 0.083, and 0.068 SD for APTT-LS.
Reproducibility of the two reagents yielded a 0.71% cocfficient of variation at 0.25 U/ml and 0.54% CV at 0.35 U/ml heparin, compared to APTT-LS 1.03% CV and 0.91% CV, respectively.
The performance data presented here, as well as the undistinguishable intended use and technological characteristics support the substantial cquivalence claim for Wortham Laboratories Intrin-EA to Pacific Hemostasis APTT-LS. Based on the data provided, it is our conclusion that these two products are substantially equivalent.
{18}------------------------------------------------
MAY 1 5 2007
Premarket Notification 510 (k) Summary
Intrin-SI APTT Reagent
The assigned 510K number is: K060968
| Applicant: | Wortham Laboratories, Inc.6340 Bonny Oaks DrChattanooga, TN 37416Tel: (423) 296-0090Fax: (423) 296-0188 |
|---|---|
| Contact: | Leon Wortham |
| Date: | April 6, 2007 |
| Device Name: | Wortham Laboratories Intrin-SI APTT Reagent is a liquid stable extract ofrabbit brain thromboplastin, containing stabilizers and buffers. Intrin-SI is anin-vitro diagnostic reagent intended for use for the performance of a citratedPartial Thromboplastin Time (APTT) testing and quantitative PTT-based factorassays for Factors XII, XI, IX and VIII. |
| Common Name: | Activated Partial Thromboplastin Time (APTT) |
| Classification Name: | Activated Partial Thromboplastin is a class II device, as per 21 CFR 864.7925(Product Code GFO). This device is intended for clinical use in conjunctionwith an analyzer to measure clot formation. |
| Predicate: | Pacific Hemostasis Kontact (K023362) |
Description
Wortham Laboratories Intrin-SI APTT reagent is intended for use in determining activated partial thromboplasin time (APTT) and coagulation factor assays that are based on a modified APTT. The capacity of blood to form a fibrin clot by way of the intrinsic hemostatic pathway requires coagulation factors XII, XI, VIII, platelet lipids and calcium. The assay is performed by the addition of a suspension of rabbit cephalin with the surface activator Kaolin.
Intended Use
Wortham Laboratories Intrin-SI is an in-vitro diagnostic reagent used in the clinical laboratory for the quantitative determination of Activated Partial Thromboplastin Time (APTT) testing for the detection of coagulation abnormalities in the intrinsic pathway. Intrin-SI reagent is sensitive to heparin and lupus anticoagulant plasmas.
Labeling
{19}------------------------------------------------
| CharacteristicsIntended Use | New DevicePerformance of Activated PartialThromboplastin Time (APTT) testing for thedetection of coagulation abnormalities in theintrinsic pathway | PredicatePerformance of Activated PartialThromboplastin Time (APTT) testing for thedetection of coagulation abnormalities in theintrinsic pathway | ||||||
|---|---|---|---|---|---|---|---|---|
| ReagentComposition | Liquid Rabbit Thromboplastin with a siliconactivator | Liquid Rabbit Thromboplastin with a siliconactivator | ||||||
| Stability | 12 months @≤ -2° C30 days @ 2-4° C | 12 months @ 2-8° C30 days @ 2-8° C, open | ||||||
| ReferenceValues | within-run | CV% | within-run | CV% | ||||
| Level 1 | 0.29% | Level 1 | 1.54% | |||||
| Level 2 | 0.74% | Level 2 | 1.00% | |||||
| Level 3 | 0.75% | Level 3 | 1.16% | |||||
| run-run | CV% | run-run | CV% | |||||
| Level 1 | 0.29% | Level 1 | 1.20% | |||||
| Level 2 | 0.75% | Level 2 | 1.01% | |||||
| Level 3 | 0.75% | Level 3 | 1.15% | |||||
| Heparin Sensitivity | CV% | Heparin Sensitivity | CV% | |||||
| 0.25 U/ml | 1.57% | 0.25 U/ml | 2.30% | |||||
| 0.35 U/ml | 1.53% | 0.35 U/ml | 2.02% | |||||
| Lupus Sensitivity | CV% | Lupus Sensitivity | CV% | |||||
| 6.37% | 16.80% | |||||||
| Factor Assay | CV% | Factor Assay | CV% | |||||
| Factor VIII | 0.13% | Factor VIII | 0.31% | |||||
| Factor IX | 0.10% | Factor IX | 0.32% | |||||
| Factor XI | 0.16% | Factor XI | 0.26% | |||||
| Factor XII | 0.18% | Factor XII | 0.34% | |||||
| ExpectedRange | Mean (sec) | Mean (sec) | ||||||
| % | VIII | IX | XI | XII | VIII | IX | XI | XII |
| 100 | 28.52 | 29.59 | 29.17 | 28.56 | 27.85 | 28.12 | 28.05 | 27.78 |
| 50 | 34.77 | 34.77 | 32.78 | 30.35 | 33.75 | 34.08 | 31.38 | 29.26 |
| 40 | 38.02 | 38.02 | 35.80 | 34.23 | 36.14 | 37.21 | 34.80 | 33.13 |
| 30 | 42.31 | 42.61 | 39.57 | 37.83 | 40.90 | 41.74 | 38.52 | 36.64 |
| 20 | 49.91 | 50.22 | 46.00 | 41.59 | 47.22 | 49.16 | 45.15 | 40.31 |
| 10 | 57.21 | 56.14 | 53.68 | 48.83 | 54.18 | 55.12 | 52.32 | 47.67 |
| Storage | ≤ -2° C | 2 - 8° C | ||||||
| Assay Factors | APTT, Heparin, FactorsVIII, IX, XI, XII | APTT, Heparin, FactorsVIII, IX, XI, XII |
.
{20}------------------------------------------------
Conclusions
Intrin-Sl
Wortham Laboratories Intrin-SI and Pacific Hemostasis Kontact reagents have the same intended use, as for the quantitative measurement of the Activated Partial Thromboplastin Time (APTT), Heparin, and Factors VIII, IX, XI, XII. Both reagents arc preparations of rabbit thromboplastin and a silicon activator from kaolin.
All assays were measured on the fibrometer vielding an APTT standard deviation of 0.0863, 0.4135 and 0.5278 for Intrin-SI on Level 1, Level 2, Level 3 plasma controls, respectively, compared to Pacific Hemostasis Kontact of 0.1989, 0.5721, 0.6465 standard deviation on the same controls.
Intrin-SI sensitivity to heparin at 0.25 U/ml, yielded a 0.2236 standard deviation to both levels of heparin compared to 0.3078 and 0.3664 standard deviation, respectively, in the predicate product.
Comparing the precision of the two reagents in the factor assays produced a standard deviation of 0.036, 0.030, 0.046, and 0.050 SD for Factors VIII, IX, XII, respectively for Intrin-SI, to 0.087, 0.089, 0.074, and 0.096 SD for Kontact.
Reproducibility of the two reagents yielded a 0.67% coefficient of variation at 0.25 U/ml and 0.48% CV at 0.35 U/ml heparin, compared to Kontact 0.94% CV and 0.72% CV, respectively.
The performance data presented here, as well as the undistinguishable intended use and technological characteristics support the substantial equivalence claim for Wortham Laboratories Intrin-St to Pacific Hemostasis Kontact. Based on the data provided, it is our conclusion that these two products are substantially equivalent.
{21}------------------------------------------------
MAY 15 2007
Wortham Laboratories, Inc.
Premarket Notification 510 (k) Summary
Fibrinogen Control Plasma
The assigned 510K number is: K060968
| Applicant: | Wortham Laboratories, Inc.6340 Bonny Oaks DrChattanooga, TN 37416Tel: (423) 296-0090Fax: (423) 296-0188 |
|---|---|
| Contact: | Leon Wortham |
| Date: | April 6, 2007 |
| Device Name: | Wortham Laboratories Fibrinogen Control Plasma (Low). |
| Common Name: | Fibrinogen Control Plasma |
| Classification Name: | Plasma, Coagulation Control, is a class II device as per 21 CFR 864.5425(Product Code GHH). This device is intended for clinical use in conjunctionwith an analyzer to measure clot formation. |
| Predicate: | Pacific Hemostasis Fibrinogen Assay (K800826) |
Description
Wortham Laboratories Fibrinogen Low Control is a liquid stable preparation of citrated plasma obtained from healthy donors, which contains stabilizers and buffers. Each unit of source material used in the preparation of the control has been tested by an FDA approved method and found non-reactive for HBsAg and negative for antibodies to HIV and HCV.
Intended Use
Wortham Laboratories Fibrinogen Control Low, a quantitative control plasma, is intended for use in the quality control of fibrinogen assays.
Labeling
{22}------------------------------------------------
| Characteristics | New Device | Predicate | ||
|---|---|---|---|---|
| Intended Use | To determine quantitative level of fibrinogen in plasma sample, and for quality control in monitoring heparin therapy with APTT testing | To determine quantitative level of fibrinogen in plasma sample, and for quality control in monitoring heparin therapy with APTT testing | ||
| ControlComposition | Liquid Human citrated plasma | Lypholyzed Human citrated plasma | ||
| Stability | 12 months @≤ -2° C30 days @ 2-4° C | 24 months @ 2-8° C, lypholyzed16 hours @ 2-8° C, rehydrated | ||
| ReferenceValues | within-run | within-run | CV% | |
| Normal | 0.56% | Normal | 0.59% | |
| Low | 0.60% | Low | 0.63% | |
| run-run | run-run | CV% | ||
| Normal | 0.57% | Normal | 0.60% | |
| Low | 0.58% | Low | 0.67% | |
| Expected Range | Mechanical | Mean | ± 2SD | |
| Normal | 306.3 | MechanicalNormal | 301-313 g/dl | |
| Low | 99.1 | Low | 97-103 g/dl | |
| Storage | ≤ -2° C | 2 - 8° C | ||
| Assay Factors | Fibrinogen | Fibrinogen |
Conclusions
Wortham Laboratories Low Fibrinogen Control and Pacific Hemostasis Low Fibrinogen Control have the same intended use, as for the quantitative measurement of fibrinogen levels in human plasma. Both are preparations of citrated human plasma, obtained from normal donors with added stabilizers and buffers.
Mechanical assays produced a standard deviation of 0.092 for Wortham Laboratories Fibrinogen Control, compared to a 0.095 standard deviation for Pacific Hemostasis Fibrinogen Control.
Reproducibility of the two controls yielded a 0.60% within-run coefficient of variation and a run-run 0.58% CV for Wortham Laboratories Fibrinogen Control compared respectively to the predicate control of 0.63% CV and 0.67% CV.
The performance data presented here, as well as the undistinguishable intended use and technological characteristics support the substantial equivalence claim for Wortham Laboratories Low Fibrinogen Control to Pacific Hemostasis Low Fibrinogen Control. Based on the data provided, it is our conclusion that these two products are substantially equivalent.
{23}------------------------------------------------
104096Y
MAY 1 5 2007
Premarket Notification 510 (k) Summary
Fibrinogen Control Plasma
The assigned 510K number is: K060968
| Applicant: | Wortham Laboratories, Inc.6340 Bonny Oaks DrChattanooga, TN 37416Tel: (423) 296-0090Fax: (423) 296-0188 |
|---|---|
| Contact: | Leon Wortham |
| Date: | April 6, 2007 |
| Device Name: | Wortham Laboratories Fibrinogen Control Plasma (Normal) |
| Common Name: | Fibrinogen Control Plasma |
| Classification Name: | Plasma, Coagulation Control, is a class II device as per 21 CFR 864.5425(Product Code GHH). This device is intended for clinical use in conjunctionwith an analyzer to measure clot formation. |
| Predicate: | Pacific Hemostasis Fibrinogen Assay (K800826) |
Description
Wortham Laboratories Fibrinogen Normal Control is a liquid stable preparation of citrated plasma obtained from healthy donors, which contains stabilizers and buffers. Each unit of source material used in the preparation of the control has been tested by an FDA approved method and found non-reactive for HBsAg and negative for antibodies to HIV and HCV.
Intended Use
Wortham Laboratories Fibrinogen Control Normal, a quantitative control plasma, is intended for use in the quality control of fibrinogen assays.
Labeling
{24}------------------------------------------------
| CharacteristicsIntended Use | New DeviceTo determine quantitative level of fibrinogen inplasma sample, and for quality control inmonitoring heparin therapy with APTT testing | PredicateTo determine quantitative level of fibrinogenin plasma sample, and for quality control inmonitoring heparin therapy with APTTtesting | ||||
|---|---|---|---|---|---|---|
| ControlComposition | Liquid Human citrated plasma | Lypholyzed Human citrated plasma | ||||
| Stability | 12 months @ ≤ -2° C30 days @ 2-4° C | 24 months @ 2-8° C, lypholyzed16 hours @ 2-8° C, rehydrated | ||||
| ReferenceValues | within-run | CV% | within-run | CV% | ||
| Normal | 0.56% | Normal | 0.59% | |||
| Low | 0.60% | Low | 0.63% | |||
| run-run | CV% | run-run | CV% | |||
| Normal | 0.57% | Normal | 0.60% | |||
| Low | 0.58% | Low | 0.67% | |||
| Expected Range | Mechanical | Mean | ± 2SD | Mechanical | Mean | ± 2SD |
| Normal | 306.3 | 301-313 g/dl | Normal | 306.3 | 297-315 g/dl | |
| Low | 99.1 | 97-103 g/dl | Low | 99.8 | 97-104 g/dl | |
| Storage | ≤ -2° C | 2 - 8° C | ||||
| Assay Factors | Fibrinogen | Fibrinogen |
Conclusions
Wortham Laboratories Normal Fibrinogen Control and Pacific Hemostasis Normal Fibrinogen Control have the same intended use, as for the quantitative measurement of fibrinogen levels in human plasma. Both are preparations of citrated human plasma, obtained from normal donors with added stabilizers and buffers.
Mechanical assays produced a standard deviation of 0.085 for Wortham Laboratories Fibrinogen Control, compared to a 0.089 standard deviation for Pacific Hemostasis Fibrinogen Control.
Reproducibility of the two controls yielded a 0.56% within-run coefficient of variation and a run-run 0.53% CV for Wortham Laboratories Fibrinogen Control compared respectively to the predicate control of 0.59% CV and 0.60% CV.
The performance data presented here, as well as the undistinguishable intended use and technological characteristics support the substantial equivalence claim for Wortham Laboratories Normal Fibrinogen Control to Pacific Hemostasis Normal Fibrinogen Control. Based on the data provided, it is our conclusion that these two products are substantially equivalent.
{25}------------------------------------------------
Premarket Notification 510 (k) Summary
MAY 1.5 2007
Thrombin Reagent
The assigned 510K number is: K060968
| Applicant: | Wortham Laboratories, Inc.6340 Bonny Oaks DrChattanooga, TN 37416Tel: (423) 296-0090Fax: (423) 296-0188 |
|---|---|
| Contact: | Leon Wortham |
| Date: | April 6, 2007 |
| Device Name: | Wortham Laboratories Thrombin Reagent |
| Common Name: | Thrombin Time Test |
| Classification Name: | Fibrinogen Determination System, class II, 21 CFR 864.7340(Product Code GJA and KQJ). This device is intended for clinical use inconjunction with an analyzer to measure clot formation. |
| Predicate: | Pacific Hemostasis Thrombin Reagent (K970645) |
Description
Wortham Laboratories Thrombin Reagent is a liquid stable preparation of activated bovine proteins (Factor IIa).
Intended Use
Wortham Laboratories Thrombin Reagent is intended for thrombin to convert fibrinogen in the quantitative determination of fibrinogen in plasma samples.
Labeling
{26}------------------------------------------------
| CharacteristicsIntended Use | New DeviceTo determine quantitative level offibrinogen in plasma sample. | PredicateTo determine quantitative level offibrinogen in plasma sample. |
|---|---|---|
| ReagentComposition | Liquid bovine thrombin | Lypholyzed bovine thrombin |
| Stability | 12 months @≤ -2° C30 days @ 2-4° C | 28 months @ 2-8° C, lypholyzed1 day @ 2-8° C, rehydrated |
| Reference Values | CV%within-run 0.67%run-run 0.68% | CV%within-run 0.68%run-run 0.71% |
| Expected Range | Mechanical Mean + 2SD119 118-120 IU/ml | Mechanical Mean + 2SD119 118-120 IU/ml |
| Storage | < -2° C | 2 - 8° C |
| Assay Factors | Fibrinogen | Fibrinogen |
Conclusion
Wortham Laboratories Thrombin Reagent and Pacific Hemostasis Thrombin Reagent have the same intended use, as normal reagents for reactive coagulation assays. Both are preparations of activated bovine protein (Factor IIa). The performance data presented here, as well as the indistinguishable intended use and technological characteristics, support the substantial equivalence claim for Wortham Laboratories Thrombin Reagent to Pacific Hemostasis Thrombin Reagent. Based on the data provided, it is our conclusion that these two products are substantially equivalent.
{27}------------------------------------------------
MAY 15 2007
Premarket Notification 510 (k) Summary
Heparin Control Plasma
The assigned 510K number is: K060968
| Applicant: | Wortham Laboratories, Inc. |
|---|---|
| 6340 Bonny Oaks Dr | |
| Chattanooga, TN 37416 | |
| Tel: (423) 296-0090 | |
| Fax: (423) 296-0188 | |
| Contact: | Leon Wortham |
| Date: | April 6, 2007 |
| Device Name: | Wortham Laboratories Heparin Control Plasma Level 1 (0.25 U/ml) |
| Common Name: | Heparin Control Plasma Level |
| Classification Name: | Plasma, Coagulation Control, is a class II device as per 21 CFR 864.5425 (Product Code GGN). This device is intended for clinical use in conjunction with an analyzer to measure clot formation. |
| Predicate: | Pacific Hemostasis Heparin Control Level I (K992278) |
Description
Wortham Laboratories Heparin Control Level 1 is a liquid stable preparation of citrated plasma obtained from healthy donors, which contains sodium heparin, stabilizers and buffers. Each unit of source material used in the preparation of the control has been tested by an FDA approved method and found non-reactive for HBsAg and negative for antibodies to HIV and HCV.
Intended Use
Wortham Laboratories Heparin Control Level 1, is intended as a quality control of the Activated Partial Thromboplastin Time (APTT) during heparin monitoring.
Labeling
{28}------------------------------------------------
| CharacteristicsIntended Use | New Device | Predicate | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| ControlComposition | Liquid Human citrated plasma with heparin | Lypholyzed Human citrated plasma with heparin | ||||||||||||||||||
| Stability | 12 months @ ≤ -2° C30 days @ 2-4° C | 36 months @ 2-8° C, lypholyzed8 hours @ 2-8° C, rehydrated | ||||||||||||||||||
| ReferenceValues | within-run | within-run | ||||||||||||||||||
| 0.25 U/ml 1.82% 0.35 U/ml 1.77% | 0.25 U/ml 2.14% 0.35 U/ml 2.04% | |||||||||||||||||||
| run-run | run-run | |||||||||||||||||||
| 0.25 U/ml 1.92% 0.35 U/ml 1.81% | 0.25 U/ml 2.27% 0.35 U/ml 2.07% | |||||||||||||||||||
| Expected Range | Mechanical Mean ± 2SD Level 1 46.82 45.2-48.5 sec Level 2 63.49 62.4-64.6 sec | Mechanical Mean ± 2SD Level 1 46.94 44.8-49.1 sec Level 2 62.64 60.1-65.2 sec | ||||||||||||||||||
| Storage | ≤ -2° C | 2 - 8° C | ||||||||||||||||||
| Assay Factors | Heparin | Heparin |
Conclusions
Wortham Laboratories Heparin Control Level 1 and Pacific Hemostasis Heparin Control Level 1 have the same intended use, as for quality control in monitoring heparin therapy with APTT testing. Both are prepared from porcine heparin in normal human citrated plasma. The APTT value will be in the slightly abnormal range for Level 1 Heparin Control.
Mechanical assays produced a within-run standard deviation of 0.8296 and a 0.8930 run-run standard deviation for Wortham Laboratories Level 1 Heparin Control, compared to the predicate control of 1.0640 and 1.0859 standard deviation, respectively.
Reproducibility of the two controls yielded a 1.33% within-run coefficient of variation and a run-run 1.92% CV for Wortham Laboratories Heparin Control Level 1, compared respectively to the predicate control of 2.15% CV and 2.27% CV.
The performance data presented here, as well as the undistinguishable intended use and technological characteristics support the substantial equivalence claim for Wortham Laboratories Heparin Control Level I to Pacific Hemostasis Heparin Control Level 1. Based on the data provided, it is our conclusion that these two products are substantially equivalent.
{29}------------------------------------------------
K0600968
MAY 15 2007
Premarket Notification 510 (k) Summary
Heparin Control Plasma
The assigned 510K number is: K060968
| Applicant: | Wortham Laboratories, Inc.6340 Bonny Oaks DrChattanooga, TN 37416Tel: (423) 296-0090Fax: (423) 296-0188 |
|---|---|
| Contact: | Leon Wortham |
| Date: | April 6, 2007 |
| Device Name: | Wortham Laboratories Heparin Control Plasma Level 2 (0.35 U/ml). |
| Common Name: | Heparin Control Plasma Level 2 |
| Classification Name: | Plasma, Coagulation Control, is a class II device as per 21 CFR 864.5425(Product Code GGN). This device is intended for clinical use in conjunctionwith an analyzer to measure clot formation. |
| Predicate: | Pacific Hemostasis Heparin Control Level II (K992279) |
Description
Wortham Laboratories Heparin Control Level 2 is a liquid stable preparation of citrated plasma obtained from healthy donors, which contains sodium heparin, stabilizers and buffers. Each unit of source material used in the preparation of the control has been tested by an FDA approved method and found non-reactive for HBsAg and negative for antibodics to HIV and HCV.
Intended Use
Wortham Laboratories Heparin Control Level 2, is intended as a quality control of the Activated Partial Thromboplastin Time (APTT) during heparin monitoring.
Labeling
{30}------------------------------------------------
| CharacteristicsIntended Use | New DeviceUsed in heparin assay for quality control inmonitoring heparin therapy with APTT testing,yielding slightly abnormal range for Level 1(0.25 U/ml) and marked abnormal range forLevel 2 (0.35 U/ml) | PredicateUsed in heparin assay for quality control inmonitoring heparin therapy with APTTtesting, yielding slightly abnormal range forLevel 1 (0.25 U/ml) and marked abnormalrange for Level 2 (0.35 U/ml) | |||||
|---|---|---|---|---|---|---|---|
| ControlComposition | Liquid Human citrated plasma with heparin | Lypholyzed Human citrated plasma withheparin | |||||
| Stability | 12 months @ ≤ -2° C30 days @ 2-4° C | 36 months @ 2-8° C, lypholyzed8 hours @ 2-8° C, rehydrated | |||||
| ReferenceValues | within-run | CV% | within-run | CV% | |||
| 0.25 U/ml | 1.82% | 0.25 U/ml | 2.14% | ||||
| 0.35 U/ml | 1.77% | 0.35 U/ml | 2.04% | ||||
| run-run | CV% | run-run | CV% | ||||
| 0.25 U/ml | 1.92% | 0.25 U/ml | 2.27% | ||||
| 0.35 U/ml | 1.81% | 0.35 U/ml | 2.07% | ||||
| Expected Range | Mechanical | Mean | ± 2SD | Mechanical | Mean | ± 2SD | |
| Level 1 | 46.82 | 45.2-48.5 sec | Level 1 | 46.94 | 44.8-49.1 sec | ||
| Level 2 | 63.49 | 62.4-64.6 sec | Level 2 | 62.64 | 60.1-65.2 sec | ||
| Storage | ≤ -2° C | 2 - 8° C | |||||
| Assay Factors | Heparin | Heparin | |||||
Conclusions
Wortham Laboratories Heparin Control Level 2 and Pacific Hemostasis Heparin Control Level 2 have the same intended use, as for quality control in monitoring heparin therapy with APTT testing. Both are prepared from porcine heparin in normal human citrated plasma. The APTT value will be in the slightly abnormal range for Level 2 Heparin Control.
Mechanical assays produced a within-run standard deviation of 1.1205 and a 1.1496 run-run standard deviation for Wortham Laboratories Level 2 Heparin Control, compared to the predicate control of 1.2775 standard deviation, respectively.
Reproducibility of the two controls yiclded a 1.77% within-run coefficient of variation and a run-run 1.81% CV for Wortham Laboratories Heparin Control Level 2, compared respectively to the predicate control of 2.047% CV and 2.07% CV.
The performance data presented here, as well as the undistinguishable intended use and technologival characteristics support the substantial equivalence claim for Wortham Laboratories Heparin Control Level 2 to Pacific Hemostasis
{31}------------------------------------------------
Heparin Control Level 2. Based on the data provided, it is our conclusion that these two products are substantially equivalent.
:
:
:
.
:
:
{32}------------------------------------------------
16600768
WORTHAM LABORATORIES, INC.
MAY 1 5 2007
DRAFT Calcium Chloride 0.02 M
Intended Use
Wortham Laboratories Calcium Chloride Solution 0.02 M (CaCl2) is intended for quantitative use with ellagic acid (Intrin-EA) or silicon particulate activators (Intrin-SI) in performing the activated partial thromboplastin time (APTT) on citrated plasma.
| Refer to Catalogue Number 4002-03-1 | (Intrin-SI) |
|---|---|
| Refer to Catalogue Number 4002-03-2 | (Intrin-EA) |
Reagents
IVD
For in vitro diagnostic use
Composition : 0.222% M calcium chloride, 0.1% sodium azide.
Warning: Calcium Chloride Solution contains sodium azide under acid conditions yields hydrozoic acid, an extremely toxic compound. Dilute with running water before discarding, and then flush with a large volume of water. These precautions are recommended to avoid deposits in metal pipetting in which explosive conditions may develop.
Store this product at ≤ - 2º C.
Materials Provided:
Calcium Chloride (0.02M), 1 x 10 ml
Ordering Information
| Cat. No. | Description | Contents |
|---|---|---|
| 4002-04-1 | CaCl2 (0.02M) | 10 ml |
| 4002-03-1 | Intrin-SI | 10 ml |
| 4002-03-2 | Intrin-EA | 10 ml |
| WORTHAM LABORATORIES, INC. |
|---|
| CHATTANOOGA, TN 37416 USA |
D()C:2019 ()2/07 Catalogue No. 4002-04-1 ( E
{33}------------------------------------------------
K0600968
Premarket Notification 510 (k) Summary
Fibrinogen Assay Set
The assigned 510K number is: K060968
| Applicant: | Wortham Laboratories, Inc.6340 Bonny Oaks DrChattanooga, TN 37416Tel: (423) 296-0090Fax: (423) 296-0188 |
|---|---|
| Contact: | Leon Wortham |
| Date: | April 6, 2007 |
| Device Name: | Wortham Laboratories Fibrinogen Assay Set |
| Common Name: | Fibrinogen Control Plasma |
| Classification Name: | Plasma, Coagulation Control, is a class II device as per 21 CFR 864.5425(Product Code GHH). This device is intended for clinical use in conjunctionwith an analyzer to measure clot formation. |
| Predicate: | Pacific Hemostasis Fibrinogen Assay (K800826) |
Description
Wortham Laboratories Fibrinogen Assay Set contains a liquid stable preparation of citrated plasma obtained from healthy donors, which contains stabilizers, buffers, and a bovine reagent and buffer solution which are also provided in the set. Each unit of source material used in the preparation of the control has been tested by an EDA approved method and found non-reactive for HBsAg and negative for antibodies to HIV and HCV.
Intended Use
Wortham Laboratories Fibrinogen Assay Set, containing a complete set of Normal Fibrinogen Control (200-400 mg/dl), Thrombin Reagent (100 IU/ml), and Fibrinogen Buffer, is intended for use in the quantitative determination of fibrinogen in plasma samples.
Labeling
{34}------------------------------------------------
| CharacteristicsIntended Use | New DeviceTo determine quantitative level of fibrinogen inplasma sample, and for quality control inmonitoring heparin therapy with APTT testing | PredicateTo determine quantitative level of fibrinogenin plasma sample, and for quality control inmonitoring heparin therapy with APTTtesting | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| ReagentComposition | Liquid Bovine Thrombin | Lypholyzed Bovine Thrombin | ||||||||||||||||||||||||
| Stability | 12 months @≤ -2° C30 days @ 2-4° C | 24 months @ 2-8° C, lypholyzed16 hours @ 2-8° C, rehydrated | ||||||||||||||||||||||||
| ReferenceValues | within-runCV% Normal 0.56% Low 0.60% CV% Normal 0.57% Low 0.58% | within-runCV% Normal 0.59% Low 0.63% CV% Normal 0.60% Low 0.67% | ||||||||||||||||||||||||
| Expected Range | MechanicalMean ± 2SD Normal 306.3 301-313 g/dl Low 99.1 97-103 g/dl | MechanicalMean ± 2SD Normal 306.3 297-315 g/dl Low 99.8 97-104 g/dl | ||||||||||||||||||||||||
| Storage | ≤ - 2° C | 2 - 8° C | ||||||||||||||||||||||||
| Assay Factors | Fibrinogen | Fibrinogen |
Conclusions
Wortham Laboratories Fibrinogen Assay Set and Pacific Hemostasis Fibrinogen Assay Set have the same intended use, as for the quantitative measurement of fibrinogen levels in human plasma. Both are preparations of citrated human plasma, obtained from normal donors with added stabilizers and using bovine thrombin as the activating reagent.
Mechanical assays produced a standard deviation of 0.085 for Wortham Laboratories Fibrinogen Control, compared to a 0.089 standard deviation for Pacific Hemostasis Fibrinogen Control.
Reproducibility of the two controls yielded a 0.56% within-run coefficient of variation and a run-run 0.53% CV for Wortham Laboratories Fibrinogen Control compared respectively to the predicate control of 0.59% CV and 0.60% CV.
The performance data presented here, as well as the undistinguishable intended use and technological characteristics support the substantial equivalence claim for Wortham Laboratories Fibrinogen Assay Set to Pacific Hemostasis Fibrinogen Assay Set. Based on the data provided, it is our conclusion that these two products are substantially equivalent.
{35}------------------------------------------------
WORTHAM LABORATORIES, INC.
MAY 15 2007
DRAFT
Fibrinogen Buffer
Intended Use
Buffer is designed as a diluent for fibrinogen studies.
Reagents
For in vitro diagnostic use IVD
Fibrinogen Buffer : 1.3% TAPSO Buffer. 0.9% sodium chloride, 0.1% sodium azide and stabilizers; pH 7.35 ± 0.05.
Store at ≤ - 2º C. Unused portions of open bottles will remain stable when stored at 2-4ºC unless contaminated.
A void contamination by exercising care during multiple pipettings. Physical signs of deterioration are limited to visual microbial contamination.
Warning: Fibrinogen Buffer contains sodium azide under acidic conditions yields hydrozoic acid, and extremely toxic compounds should be flushed with large volumes of water. Those precautions are recommended to avoid deposits in metal pipes in which explosive conditions may develop.
Ordering Information
| Cat No. | Description | Contents |
|---|---|---|
| 4002-05-3 | Fibrinogen Buffer | 100 ml |
| 4002-05-1 | Fibrinogen Control, Normal | 10 ml |
| 4002-05-2 | Fibrinogen Control, Low | 10 ml |
| 4002-05-3 | Fibrinogen Assay Set | |
| Fibrinogen Control Normal | 5 ml | |
| Thrombin Reagent | 5 ml | |
| Fibrinogen Buffer | 200 ml |
WORTHAM LABORATORIES, INC. CHATTANOOGA, TN 37416 USA
DOC:2026 02/07 Catalogue No. 4002-05-3 ( €
{36}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES.
Image /page/36/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around the perimeter. Inside the circle is an image of an eagle with its wings spread, clutching a caduceus in its talons. The eagle is facing to the left.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
MAY 1 5 2007
Mr. Leon Wortham, President and CEO Wortham Laboratories, Inc. 6340 Bonny Oaks Drive Chattanooga, TX 37416
Re: K060968
Trade/Device Name: Wortham Laboratories Stasis 1 Coagulation Control (Normal) Regulation Number: 21 CFR 864.5425 Regulation Name: Multipurpose System for in vitro coagulation studies. Regulatory Class: Class II Product Code: GIZ, GGC, GGN, GJS, GFO, GIL, KQJ Dated: April 05, 2007 Received: April 09, 2007
Dear Mr. Wortham:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA), You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
{37}------------------------------------------------
Page 2 -
If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0484. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html
Sincerely yours,
Robert Beckerh
Robert L. Becker, Jr., MD, PHD Director Division of Immunology and Hematology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
{38}------------------------------------------------
510(k) Number (if known): K060968
Device Name: Wortham Laboratories Stasis 1 Coagulation Control (Normal)
Indications For Use:
Wortham Laboratories Stasis 1 Coagulation Control (Normal) is intended for use as a quality control to monitor the performance of Prothrombin Time (PT), Activated Partial Thromboplastin Time (APTT) and Fibrinogen assays. It will yield PT, APTT, and Fibrinogen values in the normal range.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Duschin Bautista
Division Sign-Off
Divisibi
Office of In Vitro Diagnostic Device Evaluation and Safety
Page 1 of --------------------------------------------------------------------------------------------------------------------------------------------------------------------
510(k) K060968
{39}------------------------------------------------
510(k) Number (if known): K060968
Device Name: Wortham Laboratories Stasis 2 Coagulation Control (Abnormal)
Indications For Use:
Wortham Laboratories Stasis 2 Coagulation Control (Abnormal) is intended for use as a quality control to monitor the performance of Prothrombin Time (PT), Activated Partial Thromboplastin Time (APTT). It will yield PT, and APTT values in the moderate abnormal range.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Josephine Bautista
Division Sign Off
Office of In Vitro Diagnostic Device Evaluation and Safety
10(k) K060968
{40}------------------------------------------------
510(k) Number (if known): K060968
Device Name: Wortham Laboratories Stasis 3 Coagulation Control (Abnormal)
Indications For Use:
Wortham Laboratories Stasis 3 Coagulation Control (Abnormal) is intended for use as a quality control to monitor the performance of Prothrombin Time (PT), Activated Partial Thromboplastin Time (APTT). It will yield PT, and APTT values in the strongly abnormal range.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Souphene Bautister
Division Sigh-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
Page 1 of ____________________________________________________________________________________________________________________________________________________________________
10(k) K060968
{41}------------------------------------------------
510(k) Number (if known): K060968
Device Name: Wortham Laboratories Serathan-B PT Reagent
Indications For Use:
Wortham Laboratories Serathan-B PT reagent is an in-vitro diagnostic reagent intended in a clinical laboratory for the quantitative determination of Prothrombin Time (PT) testing for the detection of coagulation abnormalities in the extrinsic pathway. Serathan-B is a moderately sensitive thromboplastin reagent.
Prescription Use AND/OR X (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Josephine Bautista
Division Sign Off
Office of In Vitro Diagnostic Device Evaluation and Safety
{42}------------------------------------------------
510(k) Number (if known): K060968
Device Name: Wortham Laboratories Serathan-A PT Reagent
Indications For Use:
Wortham Laboratories Serathan-A PT reagent is an in-vitro diagnostic reagent intended in a clinical laboratory for the quantitative determination of Prothrombin Time (PT) testing for the detection of coagulation abnormalities in the extrinsic pathway. Serathan-A is a highly senstive thromboplastin reagent.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH) Office of Device Evaluation (ODE)
Juzhini Kuatita
Division Sign Off
Office of In Vitro Diagnostic Device Evaluation and Safety
106(k) K060968
{43}------------------------------------------------
510(k) Number (if known): K060968
Device Name: Wortham Laboratories Intrin-EA APTT Reagent
Indications For Use:
Wortham Laboratories Intrin-EA APTT is an in-vitro diagnostic reagent used in the clinical laboratory for the quantitative determination of Activated Partial Thromboplastin Time (APTT) testing for the detection of coagulation abnormalities in the intrinsic pathway. Intrin-EA reagent is sensitive to mild coagulopathies.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH Office of Device Evaluation (ODE)
Josephine Bautista
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
{44}------------------------------------------------
510(k) Number (if known): K060968
Device Name: Wortham Laboratories Intrin-SI APTT Reagent
Indications For Use:
Wortham Laboratories Intrin-SI is an in-vitro diagnostic reagent used in the clinical laboratory for the quantitative determination of Activated Partial Thromboplastin Time (APTT) testing for the detection of coagulation abnormalities in the intrinsic pathway. Intrin-SI reagent is sensitive to heparin and lupus anticoagulant plasmas.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Josephine Bautista
Office of In Vitro Diagnostic Device Evaluation and Safety
{45}------------------------------------------------
510(k) Number (if known): K060968
Device Name: Wortham Laboratories Fibrinogen Control Plasma Low
Indications For Use:
Wortham Laboratories Fibrinogen Control Low, a quantitative control plasma, is intended for use in the quality control of fibrinogen assays.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Josephine Bautista
Division Sign Off
Office of In Vitro Diagnostic Device Evaluation and Safety
{46}------------------------------------------------
510(k) Number (if known): K060968
Device Name: Wortham Laboratories Fibrinogen Control Plasma Normal
Indications For Use:
Wortham Laboratories Fibrinogen Control Normal, a quantitative control plasma, is intended for use in the quality control of fibrinogen assays.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) |
|---|
| -------------------------------------------------------- |
Josephine Bautista
Office of In Vitro Diagnostic Device Evaluation and Safety
Kobag68
Page 1 of ____________________________________________________________________________________________________________________________________________________________________
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510(k) Number (if known): K060968
Device Name: Wortham Laboratories Thrombin Reagent
Indications For Use:
Wortham Laboratories Thrombin Reagent is intended for thrombin to convert fibrinogen in the quantitative determination of fibrinogen in plasma samples.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) .
Concurrence of CDRH, Office of Device Evaluation (ODE)
Josephine Bautista
Office of In Vitro Diagnostic Device Evaluation and Safety
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510(k) Number (if known): K060968
Device Name: Wortham Laboratories Fibrinogen Assay Set
Indications For Use:
Wortham Laboratories Fibrinogen Assay Set, containing a complete set of Normal Fibrinogen Control (200-400 mg/dl), Thrombin Reagent (100 IU/ml), and Fibrinogen Buffer, is intend for use in the quantitative determination of fibrinogen in plasma samples.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Josephine Bautista
Office of In Vitro Diagnostic Device Evaluation and Safety
Page 1 of
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510(k) Number (if known): K060968
Device Name: Wortham Laboratories Heparin Control Plasma Level 1
Indications For Use:
Wortham Laboratories Heparin Control Level 1, is intended as a quality control of the Activated Partial Thromboplastin Time (APTT) during heparin monitoring.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Josephine Bautista
Office of In Vitro Diagnostic Device Evaluation and Safety
Page I of
Ko60968
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510(k) Number (if known): K060968
Device Name: Wortham Laboratories Heparin Control Plasma Level 2
Indications For Use:
Wortham Laboratories Heparin Control Level 2, is intended as a quality control of the Activated Partial Thromboplastin Time (APTT) during heparin monitoring.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Josephine Bautista
for Sign Off
ffice of In Vitro Diagnostic Device valuation and Safety
Ks6 0968
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510(k) Number (if known): K060968
Device Name: Wortham Laboratories Calcium Chloride Solution 0.02 M
Indications For Use:
Wortham Laboratories Calcium Chloride Solution 0.02 M (CaCl2) is intended for quantitative use with ellagic acid (Intrin-EA) or silicon particulate activators (Intrin-SI) in performing the activated partial thromboplastin time (APTT) on citrated plasma.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Josephine Bautista
e of In Vitro Diagnostic Device ation and Safe
Page 1 of ____________________________________________________________________________________________________________________________________________________________________
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510(k) Number (if known): K060968
Device Name: Wortham Laboratories Fibrinogen Buffer
Indications For Use:
Wortham Laboratories Fibrinogen Buffer is designed as a diluent for fibrinogen studies.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Josephine Bautista
Page 1 of
Tice of In Vitro Diagnostic Device ruluation and Safe
§ 864.5425 Multipurpose system for in vitro coagulation studies.
(a)
Identification. A multipurpose system for in vitro coagulation studies is a device consisting of one automated or semiautomated instrument and its associated reagents and controls. The system is used to perform a series of coagulation studies and coagulation factor assays.(b)
Classification. Class II (special controls). A control intended for use with a multipurpose system for in vitro coagulation studies is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.