(403 days)
Not Found
No
The device description and intended use are focused on chemical reagents and controls for coagulation testing, with no mention of software, algorithms, or data processing that would suggest AI/ML.
No
The devices listed are in-vitro diagnostic reagents and controls used to monitor the performance of coagulation assays in a clinical laboratory setting, not to treat patients.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that many of the reagents are "in-vitro diagnostic reagent intended in a clinical laboratory for the quantitative determination of Prothrombin Time (PT) testing for the detection of coagulation abnormalities" or "for the detection of coagulation abnormalities in the intrinsic pathway," which are direct diagnostic purposes. Even the control materials are for quality control of these diagnostic assays.
No
The device description clearly indicates that the devices are liquid stable preparations of plasma, reagents, and solutions, which are physical substances used in laboratory testing. These are not software-only components.
Based on the provided text, yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statements: Several of the product descriptions explicitly state that they are "in-vitro diagnostic reagent" (e.g., Wortham Laboratories Serathan-B PT reagent, Wortham Laboratories Intrin-EA APTT).
- Intended Use: The intended use of all the listed products is to monitor the performance of or perform assays (PT, APTT, Fibrinogen) on biological samples (plasma) in a clinical laboratory setting. This aligns directly with the definition of an in vitro diagnostic device, which is intended for use in the diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae.
- Device Description: The device descriptions detail the composition of the reagents and controls, which are designed to be used in laboratory tests.
- Performance Studies: The mention of performance studies conducted to demonstrate substantial equivalence to predicate devices, and the evaluation of metrics like Coefficient of Variation and Standard Deviation, are typical for IVD submissions.
- Predicate Devices: The listing of predicate devices with K numbers (FDA premarket notification numbers) further confirms that these products are being submitted as IVDs.
Therefore, the collective information strongly indicates that the Wortham Laboratories products described are intended for in vitro diagnostic use.
N/A
Intended Use / 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.
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 senstive 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.
Product codes (comma separated list FDA assigned to the subject device)
GIZ, GGC, GGN, GJS, GFO, GIL, KQJ
Device 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.
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 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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Clinical laboratory
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Stasis 1: Mechanical assays 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. APTT measurements produced a within-run 0.0863 and a 0.1792 standard deviation for Stasis 1, 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. Fibrinogen levels 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 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.
Stasis 2: Mechanical assays 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. APTT measurements produced a 0.4135 and a 0.2341 standard deviation for Stasis 2, 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 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.
Stasis 3: Mechanical assays 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. APTT measurements produced a 0.5278 and a 0.4928 standard deviation for Stasis 3, 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 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.
Serathan-B: 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. Precision in 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 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.
Serathan-A: 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. Precision in 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 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.
Intrin-EA: 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. 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. Precision in 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 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.
Intrin-SI: 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. 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. Precision in 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 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.
Fibrinogen Control Plasma (Low): 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 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.
Fibrinogen Control Plasma (Normal): 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 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.
Thrombin Reagent: Mechanical assays and reproducibility of the two controls yielded a 0.67% within-run coefficient of variation and a run-run 0.68% CV for Wortham Laboratories Thrombin Reagent, compared respectively to the predicate control of 0.68% CV and 0.71% CV.
Fibrinogen Assay Set: 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.
Heparin Control Plasma Level 1: 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 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.
Heparin Control Plasma Level 2: 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 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Pacific Hemostasis Coagulation Control Level I (K984129)
Pacific Hemostasis Coagulation Control Level II (K984130)
Pacific Hemostasis Coagulation Control Level III (K984131)
Pacific Hemostasis Thromboplastin-D (K994100)
Pacific Hemostasis Thromboplastin-DS (K940082)
Pacific Hemostasis APTT-LS (K891337)
Pacific Hemostasis Kontact (K023362)
Pacific Hemostasis Fibrinogen Assay (K800826)
Pacific Hemostasis Thrombin Reagent (K970645)
Pacific Hemostasis Heparin Control Level I (K992278)
Pacific Hemostasis Heparin Control Level II (K992279)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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 Dr
Chattanooga, TN 37416
Tel: (423) 296-0090
Fax: (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 use
in 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
| Characteristics
| Intended 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 | |
| Control | ||
| Composition | Liquid Human citrated plasma | Lypholyzed human citrated plasma |
| Stability | 12 months @≤ -2° C | |
| 30 days @ 2-4° С | 35 months @ 2-8° C, lypholyzed | |
| 8 hours @ 2-8° C, rehydrated | ||
| Reference | ||
| Values | 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 Dr
Chattanooga, TN 37416
Tel: (423) 296-0090
Fax: (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 use
in 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
| Characteristics
Intended Use | New Device
Routine coagulation for PT, PTT, assays in the
moderately abnormal range | Predicate
Routine coagulation for PT, PTT, assays in
the moderately abnormal range | | | | | |
|---------------------------------|-------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------|---------------------------|------------|-------|---------------|--|
| Control
Composition | Liquid Human citrated plasma | Lypholyzed human citrated plasma | | | | | |
| Stability | 12 months @ ≤ -2° C
30 days @ 2-4° C | 34 months @ 2-8° C, lypholyzed
8 hours @ 2-8° C, rehydrated | | | | | |
| Reference
Values | 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 Dr
Chattanooga, TN 37416
Tel: (423) 296-0090
Fax: (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 use
in 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° C | |||||||
| 30 days @ 2-4° C | 35 months @ 2-8° C, lypholyzed | |||||||
| 8 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 Dr
Chattanooga, TN 37416
Tel: (423) 296-0090
Fax: (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 with
an 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
:
:
| Characteristics
Intended Use | New Device
Performance of Prothrombin Time (PT) testing
for the detection of coagulation abnormalities in
the extrinsic pathway | | | | Predicate
Performance of Prothrombin Time (PT) testing
for the detection of coagulation abnormalities in
the extrinsic pathway | | | | |
|---------------------------------|------------------------------------------------------------------------------------------------------------------------------------------|-------|------------|-------|-----------------------------------------------------------------------------------------------------------------------------------------|-------|------------|-------|-------|
| Reagent
Composition | Liquid Rabbit Thromboplastin | | | | Lypholyzed Rabbit Thromboplastin | | | | |
| Stability | 12 months @ ≤ -2° C
30 days @ 2-4° C | | | | 30 months @ 2-8° C, lypholyzed
7 days @ 2-8° C, rehydrated | | | | |
| Reference
Values | | | 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% | |
| Expected
Range | 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 Dr
Chattanooga, TN 37416
Tel: (423) 296-0090
Fax: (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 with
an 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
| Characteristics
Intended Use | New Device
Performance of Prothrombin Time (PT) testing
for the detection of coagulation abnormalities in
the extrinsic pathway | Predicate
Performance of Prothrombin Time (PT) testing
for the detection of coagulation abnormalities in
the extrinsic pathway |
|---------------------------------|------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|
| Reagent
Composition | Liquid Rabbit Thromboplastin | Lypholyzed Rabbit Thromboplastin |
| Stability | 12 months @ ≤ -2° C
30 days @ 2-4° C | 30 months @ 2-8° C, lypholyzed
7 days @ 2-8° C, rehydrated |
| Reference
Values | 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% |
| Expected
Range | 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, Factors
II, V, VII, X | PT, Fibrinogen, Factors
II, 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 Dr
Chattanooga, TN 37416
Tel: (423) 296-0090
Fax: (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 conjunction
with 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 Equivalence
| Characteristics | New Device | Predicate | ||
|---|---|---|---|---|
| Intended Use | Performance of Activated Partial | |||
| Thromboplastin Time (APTT) testing for the | ||||
| detection of coagulation abnormalities in the | ||||
| intrinsic pathway | Performance of Activated Partial Thromboplastin | |||
| Time (APTT) testing for the detection of | ||||
| coagulation abnormalities in the intrinsic pathway | ||||
| Reagent | ||||
| Composition | Liquid Rabbit Thromboplastin with ellagic | |||
| acid activator | Liquid Rabbit Thromboplastin with ellagic acid | |||
| activator | ||||
| Stability | 12 months @ ≤ -2° C | |||
| 30 days @ 2-4° С | 22 months @ 2-8° C, lypholyzed | |||
| 30 days @ 2-8° C, rehydrated | ||||
| Reference | ||||
| Values | 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% | |
| Expected | ||||
| Range | 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 |