(212 days)
HemosIL ReadiPlasTin is an in vitro diagnostic thromboplastin reagent, based on recombinant human tissue factor, for the quantitative determination, in human citrated plasma, of Prothrombin Time (PT) and Fibrinogen, on the ACL TOP Family of analyzers. The product is intended to be used for the evaluation of the extrinsic coagulation pathway and the monitoring of Oral Vitamin K Antagonist Therapy.
The thromboplastin reagent included in the ReadiPlasTin kit is a liquid liposomal preparation that contains recombinant human tissue factor (RTF) in a synthetic phospholipid blend combined with calcium chloride, buffer and a preservative. In the PT test, the addition of tissue thromboplastin to the patient plasma, in the presence of calcium ions, initiates the activation of the extrinsic pathway. This results in the conversion of fibrinogen to fibrin, with the formation of a solid gel. The fibrinogen is then quantitated by relating the absorbance to a calibrator.
ReadiPlasTin can be used with II's Normal control, Routine controls 1-3, Low abnormal control, high abnormal control, ISI calibrate and INR validate.
Here's a breakdown of the requested information based on the provided text for the HemosIL ReadiPlasTin device:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Characteristic | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Precision (PT - Total %CV) | Not explicitly stated but expected to be low for clinical use. | Normal Control: 1.1 - 1.4% CV |
| Low Abnormal: 1.2 - 2.9% CV | ||
| High Abnormal: 1.4 - 1.9% CV | ||
| Precision (Fibrinogen - Total %CV) | Not explicitly stated but expected to be low for clinical use. | Normal Control: 2.0 - 2.2% CV |
| Low Abnormal: 1.8 - 2.4% CV | ||
| Low Fibrinogen: 3.1 - 3.5% CV | ||
| Fibrinogen Linearity | r ≥ 0.95 | r ≥ 0.95 (met) |
| Fibrinogen Analytical Range | Not explicitly stated but supported by linearity. | 60-700 mg/dL |
| Extrinsic Factor Linearity (II, V, VII, X) | r ≥ 0.95 | r ≥ 0.95 (met) |
| Interfering Substances (PT) | Insensitive up to specified levels. | Heparin: 1.0 IU/mL |
| LMW: 1.4 IU/mL | ||
| Hemoglobin: 500 mg/dL | ||
| Triglycerides: 1000 mg/dL | ||
| Bilirubin: 50 mg/dL | ||
| Interfering Substances (Fibrinogen) | Insensitive up to specified levels. | Heparin: 1.5 IU/mL |
| LMW: 1.7 IU/mL | ||
| Hemoglobin: 500 mg/dL | ||
| Triglycerides: 600 mg/dL | ||
| Bilirubin: 50 mg/dL | ||
| Method Comparison (PT sec) | High correlation and close agreement with predicate. | ACL TOP 700: Slope 0.913, r 0.9989 |
| ACL TOP 500: Slope 0.903, r 0.9981 | ||
| Field Site 1: Slope 0.909, r 0.9966 | ||
| Field Site 2: Slope 0.970, r 0.9972 | ||
| Field Site 3: Slope 0.889, r 0.9955 | ||
| Method Comparison (PT INR) | High correlation and close agreement with predicate. | ACL TOP 700: Slope 0.979, r 0.9975 |
| ACL TOP 500: Slope 0.937, r 0.9955 | ||
| Field Site 1: Slope 0.938, r 0.9947 | ||
| Field Site 2: Slope 0.928, r 0.9838 | ||
| Field Site 3: Slope 0.914, r 0.9945 | ||
| Method Comparison (Fibrinogen) | High correlation and close agreement with predicate. | ACL TOP 700: Slope 0.946, r 0.9955 |
| ACL TOP 500: Slope 0.975, r 0.9945 | ||
| Field Site 1: Slope 0.947, r 0.9964 | ||
| Field Site 2: Slope 0.971, r 0.9956 | ||
| Field Site 3: Slope 0.998, r 0.9931 | ||
| Fresh vs. Frozen Samples | Comparable performance expected. | Demonstrated comparable performance. |
| Normal Range Study | Not explicitly stated as acceptance criteria, but a reference range was established. | PT (sec): 10.2 - 12.9 sec |
| Fibrinogen (mg/dL): 282 - 553 mg/dL |
2. Sample Size Used for the Test Set and Data Provenance
The text describes several studies, each with specific sample sizes and implicit provenance:
- Precision/Reproducibility:
- Sample Size: 3 lots of reagent, 3 instruments (2 ACL TOP 700, 1 ACL TOP 500 CTS), 3 operators. For each control level (Normal, Low Abnormal, High Abnormal for PT; Normal, Low Abnormal, Low Fibrinogen for Fibrinogen), N=80 per instrument per lot (20 days, 2 runs/day, 2 replicates/run), totaling 240 measurements per control level per lot across all instruments.
- Data Provenance: Implied to be prospective laboratory testing conducted by the manufacturer ("utilizing 3 lots of reagent on 3 representative members of the ACL TOP Family by 3 independent operators"). Country of origin is not explicitly stated but assumed to be where the company is based (Bedford, MA, USA).
- Fibrinogen Linearity:
- Sample Size: Not explicitly stated how many samples were used, but the study was performed in accordance with CLSI EP6-A.
- Data Provenance: Implied to be retrospective (prepared linearity samples) or prospective laboratory testing. Country of origin not specified.
- Extrinsic Factor Linearity:
- Sample Size: Not explicitly stated how many samples were used for factors II, V, VII, and X.
- Data Provenance: Implied retrospective (prepared factor-deficient plasmas) or prospective laboratory testing. Country of origin not specified.
- Analytical Specificity (Interfering Substances):
- Sample Size: Not explicitly stated how many samples were tested for each interfering substance, but the study was performed according to CLSI EP7-A.
- Data Provenance: Implied retrospective (spiked samples) or prospective laboratory testing. Country of origin not specified.
- Method Comparison with Predicate Device:
- Sample Size:
- In-house: "100+ samples (Normal & Abnormal)". Specifically, n=230 for PT(sec) on ACL TOP 700, n=65 for PT (INR) on ACL TOP 700, n=241 for Fibrinogen on ACL TOP 700. Similar numbers for ACL TOP 500 CTS (n=238 for PT(sec), n=65 for PT (INR), n=242 for Fibrinogen).
- US Field Studies: Site 1: 254 for PT(sec), 76 for PT(INR), 237 for Fibrinogen. Site 2: 312 for PT(sec), 89 for PT(INR), 284 for Fibrinogen. Site 3: 135 for PT(sec), 71 for PT(INR), 129 for Fibrinogen.
- Data Provenance: The "in-house method comparison" is likely prospective or retrospective from internal lab samples. The "US field studies" are prospective patient samples from clinical sites in the US.
- Sample Size:
- Matrix Comparison (Fresh vs. Frozen):
- Sample Size: n=245 (140 normal, 105 abnormal patient samples).
- Data Provenance: Prospective patient samples. Country of origin not specified, but likely associated with the manufacturer or field sites.
- Normal Range Study:
- Sample Size: n=199 healthy subjects.
- Data Provenance: Prospective collection from healthy subjects. Country of origin not specified, but likely associated with the manufacturer or field sites.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- No "experts" in the traditional sense (e.g., radiologists interpreting images) are mentioned in this submission. This is a submission for an in vitro diagnostic reagent and system, where the "ground truth" is typically established by reference methods, accuracy against known standards, or comparison with a cleared predicate device.
- The "predicate device" (HemosIL RecombiPlasTin 2G) served as the primary comparator for establishing substantial equivalence, meaning its results were considered the "reference" or "ground truth" for comparison in the method comparison studies. The predicate device itself would have undergone its own rigorous validation.
- For the Normal Range Study, the "ground truth" was simply the biochemical values obtained from a healthy population.
4. Adjudication Method for the Test Set
- No adjudication method is described. This type of IVD submission does not typically involve human adjudication of results in the way image analysis or clinical endpoint studies might. The results are quantitative (PT in seconds/INR, Fibrinogen in mg/dL), and performance is assessed statistically by comparing the device's numerical outputs against predicate device outputs or established reference values.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No, an MRMC comparative effectiveness study was not done. This type of study is primarily relevant for diagnostic imaging interpretation or other scenarios where multiple human readers are tasked with making a subjective assessment, and the AI's impact on their performance is being evaluated. This submission is for an automated in-vitro diagnostic assay.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- Yes, the primary performance studies are standalone algorithm/device performance. This device, the HemosIL ReadiPlasTin reagent on the ACL TOP Family analyzers, is an automated system. Its performance (precision, linearity, method comparison, etc.) is measured directly by the instrument, without human intervention in the result generation process itself. Humans operate the instrument and interpret the results, but the analytical performance described is "standalone" in the sense that it reflects the device's inherent capability to produce accurate measurements.
7. The Type of Ground Truth Used
- The "ground truth" for the performance studies primarily used:
- Predicate Device Data: For the method comparison studies, the results from the HemosIL RecombiPlasTin 2G served as the comparative "truth" to demonstrate substantial equivalence.
- Reference Standards/Calibrators: Traceability is described against "ISI certified House Standard" which is calibrated against "international reference preparation according to the WHO recommendations" for PT/INR, indicating a form of metrological traceability for quantitative accuracy.
- Known Reference Samples: Clinical samples (normal and abnormal patient samples) were used to cover the operating range.
- Statistical Methodology: For precision, linearity, and interference studies, performance metrics were compared against statistical acceptance criteria (e.g., %CV, correlation coefficient r) which are based on established clinical laboratory standards (CLSI guidelines).
- Healthy Population Values: For the normal range study, the "ground truth" was derived from a statistically significant sample of healthy individuals.
8. The Sample Size for the Training Set
- The document does not explicitly mention a "training set" in the context of machine learning or AI algorithms. This is a traditional in-vitro diagnostic device (a reagent) used with an existing analyzer. The device itself is not an AI algorithm that "learns" from data.
- However, the traceability and calibration processes for the reagent involve internal "House Standards" which are themselves developed and validated using extensive data. Each batch of ReadiPlasTin is calibrated against these standards. While not a "training set" in the AI sense, this represents the historical data and standards used to ensure accurate performance of each reagent lot.
9. How the Ground Truth for the Training Set Was Established
- As noted above, there isn't a "training set" in an AI/ML context. The calibration and standardization process serves a similar function:
- House Standards: These internal reference materials are "calibrated against the corresponding international reference preparation according to the WHO recommendations." This means that the ultimate "ground truth" for the device's accuracy is established through international consensus standards and reference measurement procedures, which are the gold standard for many IVD assays.
- The "consensus values from > 200 laboratories" for INR reference values also indicate a broadly established and verified "ground truth" derived from a large number of expert laboratories.
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MAR 2 4 2013
510K SUMMARY
ASSAY ONLY TEMPLATE
A. 510(k) Number
TBD
New Assay (ReadiPlasTin only)
Instrumentation Laboratory Co.
Absorbance clot detection
HemosIL ReadiPlasTin
Prothrombin Time (PT) and Fibrinogen
-
Purpose for Submission B.
-
C. Measurand
-
D. Type of Test
-
E. Applicant
-
F. Proprietary Name
-
G. Regulatory Information
| Product Name | HemosIL ReadiPlasTin | |
|---|---|---|
| Regulation section: | 21 CFR 864.7750 | 21CFR 864.7340 |
| Classification: | Class II | Class II |
| Product code: | GJS | GIS |
| Common Name | Prothrombin Time Test | Fibrinogen Test |
| Classification name: | Test, Time, Prothrombin | Test, Fibrinogen |
| Panel: | Hematology | Hematology |
H. Intended Use
-
Intended use(s): 1.
HemosIL ReadiPlasTin is an in vitro diagnostic thromboplastin reagent, based on recombinant human tissue factor, for the guantitative determination, in human citrated plasma, of Prothrombin Time (PT) and Fibrinogen, on the ACL TOP Family of analyzers. The product is intended to be used for the evaluation of the extrinsic coagulation pathway and the monitoring of Oral Vitamin K Antagonist Therapy. -
- Indication(s) for use:
Same as intended use(s).
- Indication(s) for use:
-
Special conditions for use statement(s): 3.
For in-vitro diagnostic use only. For prescription use. -
Special instrument requirements: 4.
ACL TOP Family analyzers
I. Device Description
The thromboplastin reagent included in the ReadiPlasTin kit is a liquid liposomal preparation that contains recombinant human tissue factor (RTF) in a synthetic phospholipid blend combined with calcium chloride, buffer and a preservative. In the PT test, the addition of tissue thromboplastin to the patient plasma, in the presence of calcium ions, initiates the activation of the extrinsic pathway. This results in the conversion of fibrinogen to fibrin, with the formation of a solid gel. The fibrinogen is then quantitated by relating the absorbance to a calibrator.
ReadiPlasTin can be used with II's Normal control, Routine controls 1-3, Low abnormal control, high abnormal control, ISI calibrate and INR validate.
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J. Substantial Equivalence Information:
- Predicate device name(s): 1.
HemosIL RecombiPlasTin 2G K070005
.
-
- Predicate 510(k) #: Comparison with predicate: 3.
Table of similarities:
- Predicate 510(k) #: Comparison with predicate: 3.
| Characteristic | Predicate | Applicant |
|---|---|---|
| Company | Instrumentation Laboratory (self) | Same |
| Device Name | HemosIL RecombiPlasTin 2G | HemosIL ReadiPlasTin |
| K# | K070005 | TBD |
| Intended Use | HemosIL RecombiPlasTin 2G is ahigh sensitivity thromboplastinreagent, which is based onrecombinant human tissue factor(RTF), for the quantitativedetermination, in human citratedplasma, of Prothrombin Time(PT) on IL Coagulation andELECTRA Systems and Fibrinogenon IL Coagulation Systems only.The product is used for theevaluation of the extrinsiccoagulation pathway, and themonitoring of Oral AnticoagulantTherapy (OAT). | HemosIL ReadiPlasTin is anin vitro diagnosticthromboplastin reagent,based on recombinanthuman tissue factor (RTF),for the quantitativedetermination, in humancitrated plasma, ofProthrombin Time (PT) andFibrinogen, on the ACL TOPFamily of analyzers. Theproduct is intended to beused for the evaluation ofthe extrinsic coagulationpathway and themonitoring of Oral VitaminK Antagonist Therapy. |
| Mode of | Prothrombin MeasurementIn the PT test, the addition of thetissue thromboplastin to thepatient sample, in the presenceof calcium, initiates theactivation of the extrinsicpathway. This results in theconversion of fibrinogen to fibrin,with the formation of a solid gel.PT derived FibrinogenFibrinogen is quantitated (PTbased method) by relating theabsorbance or light scatterduring clotting to a calibrator. | Same |
| Operation | ||
| Sample Type | Citrated Plasma | Same |
Table of differences
| Characteristic | Predicate | Applicant |
|---|---|---|
| Device Name | HemosIL RecombiPlasTin 2G | HemosIL ReadiPlasTin |
| Delivery | Lyophilized | Liquid |
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K. Standard/Guidance Document Referenced (if applicable):
No FDA performance standard or FDA guidance has been established.
L. Test Principle
The thromboplastin reagent included in the ReadiPlasTin kit, after mixing with the ReadiPlasTin Diluent, is a liposomal preparation that contains recombinant human tissue factor (RTF), re-lipidated in a synthetic phospholipid blend.
In the PT test, the addition of the tissue thromboplastin (ReadiPlasTin reagent) to the patient plasma in the presence of calcium ions initiates the activation of the extrinsic pathway. This results ultimately in the conversion of fibrin, with formation of a solid gel.
The Fibrinogen is quantitated (PT-based method) by relating the absorbance or lightscatter during clotting to a calibrator.
M. Performance Characteristics
1. Analytical performance:
- Precision/Reproducibility a.
Precision and Reproducibility was assessed utilizing 3 lots of reagent on 3 representative members of the ACL TOP Family (2 ACL TOP 700 and an ACL TOP 500 CTS) by 3 independent operators. Precision was evaluated in accordance with CLSI EP05-A2, for 20 days, with 2 runs per day and 2 replicates per run for each sample level (n=80/ instrument/ lot).
Prothrombin Time (seconds)
| System | HemosILReadiPlasTin | Mean PT | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| ACL TOPFamily | Normal Control | 11.4 | 11.7 | 12.1 | ||||||
| Low Abnormal | 21.6 | 21.6 | 22.1 | |||||||
| High Abnormal | 36.2 | 35.5 | 34.8 | |||||||
| Controls | Within Run (%CV) | Between Run (%CV) | Total (%CV) | |||||||
| Normal | 0.6 | 0.6 | 0.6 | 0.1 | 0.1 | 0.1 | 1.2 | 1.4 | 1.1 | |
| Low Abnormal | 0.7 | 0.6 | 1.1 | 0.6 | 0.3 | 0.0 | 2.9 | 1.5 | 1.2 | |
| High Abnormal | 0.5 | 0.7 | 0.9 | 0.5 | 0.6 | 0.3 | 1.7 | 1.9 | 1.4 |
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Fibrinogen (mq/dL)
| Mean Fibrinogen | ||||
|---|---|---|---|---|
| System | Controls | Lot 1 Lot2 Lot3 | ||
| ACL TOP Family | Normal · | 297.5 284.6 287.9 | ||
| Low Abnormal. | 121.8 114.9 117.2 | |||
| Low Fibrinogen | 135.4 135.7 135.8 | |||
| Within Run (%CV) | Between Run (%CV) | Total (%CV) | ||
| Controls | Lot1 Lot2 Lot3 | Lot1 Lot2 Lot3 | Lot1 Lot2 Lot3 | |
| Normal | 1.21.11.2 | 1.41.41.8 | 2.02.22.0 | |
| Low Abnormal | 1.51.41.8 | 1.61.01.3 | 2.22.41.8 | |
| Low Fibrinogen | 2.93.23.4 | 0.00.00.0 | 3.53.13.5 | |
b. Linearity/assay reportable range:
Fibrinogen:
A fibrinogen linearity study was performed in accordance with CLSI EP6-A. Results met the acceptance criteria of r≥0.95, supporting the device's insert claim of a Fibrinogen Analytical Range of 60-700mg/dL.
- Traceability, Stability, Expected values (controls, calibrators, or methods): C.
Traceability
Each batch of ReadiPlasTin reagent is calibrated against an ISI certified House Standard which in turn is calibrated against the corresponding international reference preparation according to the WHO recommendations.
The reported INR Reference values were determined over multiple runs on IL coagulation systems running a specific lots of PT reagent against a House Standard ISI Calibrate, which is traceable to the current WHO International Standard identified in the INR Reference table of the product insert and consensus values from > 200 laboratories.
Stability
Unopened reagent and diluent are stable until the expiration date shown on the vial, when stored at 2-8°C. Once prepared for use, the reagent is stable for 10 days at 2-8°C in closed original vial, or for 10 days at 15°C on the ACL TOP Family in the original vial with no stirring. For optimal stability remove the reagent from the system and store it closed at 2-8°C in the original vial. Do not freeze.
- d. Detection limit:
Extrinsic Factor Linearity:
Extrinsic factor linearity studies were performed on factors II, V, VII and X. Results met the acceptance criteria at r≥0.95.
Analytical Specificity: e.
Testing for interfering substances was performed according to CLSI EP7-A. The assay was insensitive to Heparin, Hemoglobin, Triglycerides, and Bilirubin up to the following levels:
| Heparin | |||||
|---|---|---|---|---|---|
| Parameter | UFH | LMW | Hemoglobin | Triglycerides | Bilirubin |
| PT (sec) | 1.0 IU/mL | 1.4 IU/mL | 500 mg/dL | 1000 mg/dL | 50 mg/dL |
| Fibrinogen | 1.5 IU/mL | 1.7 IU/mL | 500 mg/dL | 600 mg/dL | 50 mg/dL |
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f. Assay cut-off: Not Applicable
2. Comparison studies:
Method Comparison with predicate device: a.
An in-house method comparison was performed in accordance with EP09-A2 on 100+ samples (Normal & Abnormal), comparing HemosIL ReadiPlasTin on representative members of the ACL TOP Family (ACL TOP 700 & ACL TOP 500 CTS), against HemosIL RecombiPlasTin 2G, with the following result(s)10.
| Assay | Instrument | n | Slope (95% CI) | Intercept (95% CI) | r |
|---|---|---|---|---|---|
| 'PT(sec) | ACL TOP | 230 | 0.913 (0.907-0.919) | 0.948 (0.835-1.062) | 0.9989 |
| PT (INR) | 700 | 65 | 0.979 (0.961-0.996) | 0.026 (-0.020-0.072) | 0.9975 |
| Fibrinogen | 241 | 0.946 (0.935-0.958) | -4.3 (-9.1-0.5) | 0.9955 | |
| PT(sec) | ACL | 238 | 0.903 (0.896-0.910) | 1.091(0.945-1.236) | 0.9981 |
| PT (INR) | TOP 500 | 65 | 0.937 (0.914-0.959) | 0.016 (0.100-0.232) | 0.9955 |
| Fibrinogen | CTS | 242 | 0.975 (0.962-0.988) | -7.6 (-12.9--2.2) | 0.9945 |
In US field studies, the following data were obtained using a specific lot of ReadiPlasTin on the ACL TOP:
| Parameter | Site | n | Slope (95% CI) | Intercept (95% CI) | r |
|---|---|---|---|---|---|
| PT(sec) | Site 1 | 254 | 0.909 (0.900-0.918) | 0.45 (0.24-0.66) | 0.9966 |
| Site 2 | 312 | 0.970 (0.962-0.978) | 0.51 (0.34-0.68) | 0.9972 | |
| Site 3 | 135 | 0.889 (0.874-0.903) | 1.76 (1.40-2.12) | 0.9955 | |
| PT (INR) | Site 1 | 76 | 0.938 (0.916-0.961) | 0.138 (0.079-0.197) | 0.9947 |
| Site 2 | 89 | 0.928 (0.892-0.963) | 0.119 (0.033-0.205) | 0.9838 | |
| Site 3 | 71 | 0.914 (0.891-0.937) | 0.120 (0.060-0.181) | 0.9945 | |
| Fibrinogen | Site 1 | 237 | 0.947 (0.936-0.957) | 4.5 (-0.3-9.3) | 0.9964 |
| Site 2 | 284 | 0.971(0.961-0.982) | 0.56 (-4.4-5.5) | 0.9956 | |
| Site 3 | 129 | 0.998 (0.978-1.019) | -4.2 (-13.6 to 5.2) | 0.9931 |
- b. Matrix comparison:
A fresh versus frozen sample study was performed (n=245) on both normal (n=140) and abnormal (n=105) patient samples. The results demonstrated comparable performance on fresh and once-thawed samples.
3. Clinical studies:
- Clinical Sensitivity: NA a.
- Clinical Specificity: NA b.
- Other clinical supportive data (when a. and b. are not applicable): NA C.
- Clinical cut-off: NA 4.
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5. Expected values/Reference range *:
A normal range study (n=199), was performed in accordance with CLSI C28-A3, testing healthy subjects who were not coagulated, with ReadiPlasTin reagent, on a representative member of the ACL TOP Family (ACL TOP 700). The reference range was established as:
| Assay | NR Reference Interval* | Lower Limit (95% CI) | Upper Limit (95% CI) |
|---|---|---|---|
| PT (sec) | 10.2 (9.7-10.4) | 12.9 (12.7-14.1) | |
| Fibrinogen (mg/dL) | 282 (274-332) | 553 (531-562) |
*These results were obtained using a specific lot of reagent. Due to many variables which may affect clotting times, each laboratory should verify its own normal range.
N. Proposed Labeling
The labeling is sufficient and satisfies the requirements of 21 CFR Part 809.10.
0. Conclusion
The submitted information in this premarket notification is complete and supports a substantial equivalence decision.
P. Administrative Information
Applicant Contact Information
| Name of applicant: | Instrumentation Laboratory Co. |
|---|---|
| Mailing address: | 180 Hartwell RoadBedford, MA 01730, USA |
| Phone #: | 781-861-4350 |
| Fax #: | 781-861-4207 |
| E-mail address: | jemery@ilww.com |
| Contact: | Jacqueline Emery, BSEERegulatory Affairs Manager |
Date Prepared
August 21, 2012
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles an abstract human figure or a caduceus, which is a traditional symbol of medicine.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 24, 2013
Instrumentation Laboratory Co. c/o Ms. Jacqueline Emery Regulatory Affairs Manager 180 Hartwell Road Bedford, MA 01730
Re: K122584
Trade/Device Name: HemosIL® ReadiPlasTin Regulation Number: 21 CFR § 864.7750 Regulation Name: Prothrombin time test Regulatory Class: Class II Product Code: GJS, GIS Dated: March 15, 2013 Received: March 18, 2013
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
{7}------------------------------------------------
Page 2 - Ms. Jacqueline Emery
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Leonthena R. Carrington -S
for
Maria Chan, Ph.D. Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
510(k) Number (if known): _K122584
HemosIL ReadiPlasTin Device Name:
Indications for Use:
HemosIL ReadiPlasTin is an in vitro diagnostic thromboplastin reagent, based on recombinant human tissue factor, for the quantitative determination, in human citrated plasma, of Prothrombin Time (PT) and Fibrinogen, on the ACL TOP® Family of analyzers. The product is intended to be used for the evaluation of the extrinsic coagulation pathway and the monitoring of Oral Vitamin K Antagonist Therapy.
Prescription Use V (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 In Vitro Diagnostic Devices (OIVD)
Leonthena R. Carrington -S
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k)_K122584
§ 864.7750 Prothrombin time test.
(a)
Identification. A prothrombin time test is a device used as a general screening procedure for the detection of possible clotting factor deficiencies in the extrinsic coagulation pathway, which involves the reaction between coagulation factors III and VII, and to monitor patients receiving coumarin therapy (the administration of one of the coumarin anticoagulants in the treatment of venous thrombosis or pulmonary embolism).(b)
Classification. Class II (performance standards).