(13 days)
Pacific Hemostasis Coagulation Control Level 1 is intended for use as a control to monitor the performance of routine coagulation assays, i.e. Prothrombin Time (PT), Activated Partial Thromboplastin Time (APTT) and Fibrinogen assays. It will yield PT, APTT and Fibrinogen values in the normal range.
Pacific Hemostasis Coagulation Control Level 1 (Normal) is a lyophilized preparation of citrated plasma obtained from healthy donors. Stabilizers and buffers have been added to the plasma prior to lyophilization. Each unit of source material used in the preparation of the reagent has been tested by an FDA approved method and found non-reactive for HBsAG and negative for antibodies to HIV and HCV.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Coagulation Control Level 1 (Normal) device:
1. Table of Acceptance Criteria and Reported Device Performance
The device is a Coagulation Control (Level 1, Normal) and its performance is assessed based on precision (between-run and within-run) for Prothrombin Time (PT) and Activated Partial Thromboplastin Time (APTT) assays, and the expected range for Fibrinogen. The acceptance criteria are implicitly derived from the "substantially equivalent" claim to the predicate device (Dade Ci-Trol Coagulation Control Level 1). The study demonstrates that the Pacific Hemostasis device falls within similar precision limits and expected Fibrinogen ranges as the predicate.
| Assay | Performance Metric | Acceptance Criteria (Implicit - based on predicate's performance and "substantially equivalent" claim) | Reported Device Performance (Pacific Hemostasis) | Predicate Device Performance (Dade) |
|---|---|---|---|---|
| Prothrombin Time (PT) | Between-run Precision (CV%) | Less than 2.0% | 1.22% | 1.39% |
| Within-run Precision (Avg CV%) | Less than 1.5% | 1.39% | 1.20% | |
| Activated Partial Thromboplastin Time (APTT) | Between-run Precision (CV%) | Less than 2.0% | 0.79% | 1.52% |
| Within-run Precision (Avg CV%) | Less than 1.0% | 0.70% | 0.70% | |
| Fibrinogen | Result Range | In the normal range | 287 mg/dL | 268 mg/dL |
Notes on Acceptance Criteria: The document directly states that "For both controls a CV of less than 2.0% was obtained for PT and APTT between-run testing" and "The average CV's obtained for within-run precision were less than 1.5% for PT testing, and less than 1.0% for APTT testing of both products." These statements are presented as observed performance but implicitly serve as the benchmark for substantial equivalence.
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size:
- Between-run Precision: 20 duplicate measurements over a 10-day period. This means 20 measurements for PT and 20 for APTT for both the Pacific Hemostasis product and the Dade product.
- Within-run Precision: 3 runs of 20 duplicate measurements. The average %CV is reported. This implies 60 original measurements for PT and 60 for APTT for both products to calculate the average.
- Fibrinogen: The sample size for Fibrinogen is not explicitly stated in terms of number of measurements, but a single representative value (287 mg/dL for Pacific Hemostasis and 268 mg/dL for Dade) is given.
- Data Provenance: The document does not explicitly state the country of origin of the data. However, the applicant (Pacific Hemostasis) is based in Huntersville, NC, USA. The study is a prospective performance study conducted specifically for this premarket notification.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This type of study for a coagulation control material does not typically involve human experts establishing a "ground truth" in the way a medical image diagnosis aid would. The "ground truth" here is the performance characteristics of a known, legally marketed predicate device (Dade Ci-Trol Coagulation Control Level 1) and the established normal ranges for PT, APTT, and Fibrinogen in a laboratory setting.
4. Adjudication Method for the Test Set
Not applicable. This is a laboratory performance study of a control material, not a clinical study requiring adjudication of diagnoses or interpretations.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size
No, an MRMC comparative effectiveness study was not done. This study is focused on the device's analytical performance (precision and expected range) compared to a predicate device, not on human reader performance with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, this is essentially a standalone performance study of the coagulation control material. The device itself (the control plasma) is being evaluated for its inherent analytical characteristics (precision and consistency), not as an algorithm or with human interaction once the test is set up.
7. The Type of Ground Truth Used
The "ground truth" is established by:
- The known, validated performance characteristics of the legally marketed predicate device (Dade Ci-Trol Coagulation Control Level 1).
- Clinically accepted normal ranges for PT, APTT, and Fibrinogen assays, which the control is designed to fall within.
8. The Sample Size for the Training Set
Not applicable. This is a premarket notification for a control material, not a machine learning model that requires a training set. The "development" of the product would have involved internal testing and formulation, but not in the context of a "training set" for an algorithm.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set mentioned or implied for this device.
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DEC 1 1998
510(K) Summarv Coagulation Control Level 1 (Normal)
PREMARKET NOTIFICATION 510(K) SUMMARY 7.0
Applicant: ·
Laura A. Worfolk, Ph.D. Pacific Hemostasis 11515 Vanstory Drive Huntersville, NC 28078 (704) 948-3276
Contact Person:
Trade Name:
Common Name:
Classification Name:
Equivalent Device:
Date:
Mark Ellis, Regulatory Manager, phone #(704) 948-32 Fax # (704) 875-2092 November 12, 1998 Coagulation Control Level 1 (Normal) Normal Coagulation Control Plasma, Coagulation Control (per 21 CFR section 864.5425) Dade Ci-Trol Coagulation Control Level 1, a pre-amendment device
Description of Coagulation Control Level 1 (Normal)
Pacific Hemostasis Coagulation Control Level 1 (Normal) is a lyophilized preparation of citrated plasma obtained from healthy donors. Stabilizers and buffers have been added to the plasma prior to lyophilization. Each unit of source material used in the preparation of the reagent has been tested by an FDA approved method and found non-reactive for HBsAG and negative for antibodies to HIV and HCV.
Intended Use of Coagulation Control Level 1 (Normal)
Pacific Hemostasis Coagulation Control Level 1 is intended for use as a control to monitor the performance of routine coagulation assays, i.e. Prothrombin Time (PT), Activated Partial Thromboplastin Time (APTT) and Fibrinogen assays. It will yield PT, APTT and Fibrinogen values in the normal range.
Summary of Performance Data for Substantial Equivalence Comparisons
Between-run and within-run precision studies yielded substantially equivalent data for Pacific Hemostasis and Dade Brand Coagulation Controls Level 1(I) (Table 1). For both controls a CV of less than 2.0% was obtained for PT and APTT between-run testing. The average CV's obtained for within-run precision were less than 1.5% for PT testing, and less than 1.0% for APTT testing of both products. Fibrinogen testing yielded values of 287 and 268 mg/dL for Pacific Hemostasis and Dade brands, respectively, which are both in the normal range for fibrinogen.
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| Prothrombin Time Testing | Activated PartialThromboplastin Time Testing | |||
|---|---|---|---|---|
| PH | Dade | PH | Dade | |
| Between-run Precision(20 duplicatemeasurements over a 10day period) | mean = 12.9SD = 0.16CV% = 1.22 | mean = 14.1SD = 0.20CV% = 1.39 | mean = 25.7SD = 0.20CV% = 0.79 | mean = 26.7SD = 0.40CV% = 1.52 |
| Within-run Precision(3 runs of 20 duplicatemeasurements, average%CV shown.) | 1.39 | 1.20 | 0.70 | 0.70 |
Conclusion
Pacific Hemostasis and Dade brand Coagulation Control Level I(I) have the same intended use, as normal controls for routine coagulation assays. Both are preparations of citrated plasma obtained from normal donors with added stabilizers and buffers. The performance data presented here, as well as the indistinguishable intended use and technological characteristics support the substantial equivalence claim for Pacific Hemostasis Coagulation Control Level 1 to Dade Ci-Trol Coagulation Control Level I. Based on the data provided, it is our conclusion that these two products are substantially equivalent.
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PREMARKET NOTIFICATION
TRUTHFUL AND ACCURATE STATEMENT [As required by 21 CFR 807.87(j)]
I certify that, in my capacity as a Research Scientist at Pacific Hemostasis, a Fisher Scientific Company, I believe to the best of my knowledge, that all data and information submitted in the premarket notification are truthful and accurate and that no material fact has been omitted.
Saura A. Worfolk
Laura A. Worfolk, Ph.D.
11/12/98
(Premarket Notification [510(k)] Number)
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Image /page/3/Picture/2 description: The image is a black and white seal for the Department of Health & Human Services USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
DEC 1 1998
Mark Ellis Regulatory Manager Pacific Hemostasis 11515 Vanstory Drive Huntersville, NC 28078
Re: K984129 Trade Name: Coagulation Control Level 1 (Normal) Regulatory Class: II Product Code: GIZ Dated: November 16, 1998 November 18, 1998 Received:
Dear Mr. Ellis:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 reqistration, listing of devices, qood 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal A substantially Requlations, Title 21, Parts 800 to 895. equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Steven Butman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Statement of Indications for Use
_ 澳门
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. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Pacific Hemostasis Coagulation Control Normal, Level 1, is intended for use as a control to monitor the performance of three routine coagulation assays: Prothrombin Time (PT), Activated Partial Thromboplastin Time (APTT), and fibrinogen concentration in the normal range.
Cure E. Main
Prescription.
§ 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.