(77 days)
Pacific Hemostasis Thromboplastin D 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).
Pacific Hemostasis Thromboplastin D is intended for use for performing the one-stage Prothrombin Time test (PT) and PT-based factor assays.
Pacific Hemostasis Thromboplastin D is a lyophilized extract of rabbit brain thromboplastin containing calcium, stabilizer and buffer.
Acceptance Criteria and Study for Pacific Hemostasis Thromboplastin D
This device is a Thromboplastin reagent intended for in vitro diagnostic use to perform Prothrombin Time (PT) testing and quantitative PT-based factor assays, as well as for monitoring oral anticoagulant (OAC) therapy. The study demonstrates substantial equivalence to a predicate device, Dade Thromboplastin C Plus.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Intended Use | Identical intended use as predicate device (Dade Thromboplastin C Plus): detect deficiencies in factors II, V, VII, and X (PT and PT-based factor assays); monitoring oral anticoagulant (OAC) therapy. | Met: Pacific Hemostasis Thromboplastin D has identical intended use, being formulated to detect deficiencies in factors II, V, VII and X (PT and PT-based factor assays) and for monitoring OAC therapy. |
| Technological Characteristics | Similar technological characteristics as predicate device. | Met: The device is described as a lyophilized extract of rabbit brain thromboplastin containing calcium, stabilizer, and buffer, similar to the predicate. |
| Correlation with Predicate Device (PT Testing) | High correlation coefficients (R) for PT testing of specimens from normal, abnormal, and OAC-treated patients. | Met: Correlation coefficients (R) ranging from 0.96-0.97 were obtained across two sites on multiple instruments. |
| Slope of Correlation (PT Testing) | Slopes of correlation consistent with clinical acceptance ranges for PT testing compared to predicate. | Met: Slopes ranging from 0.74-0.85 were observed. While this shows a potential bias in raw PT values, the subsequent INR conversion addresses this. |
| Bias Elimination (INR Conversion) | Elimination of bias when PT results are converted to INR, demonstrating accurate INR reporting. | Met: Bias was eliminated when results were converted to INR. |
| Correlation with Predicate Device (INR) | High correlation coefficients (R) for INR values compared to predicate device. | Met: Correlation coefficients (R) ranging from 0.95-0.97 were obtained for INR values. |
| Slope of Correlation (INR) | Slopes of correlation close to 1.0 for INR values compared to predicate device. | Met: Slope values between 0.98-1.04 were obtained for INR values, indicating excellent agreement. |
| Within-run Precision | Coefficient of Variation (CV) for within-run precision demonstrating high repeatability for the proposed device. | Met: CVs less than 3% were obtained for the proposed device. |
| Between-run Precision | Coefficient of Variation (CV) for between-run precision demonstrating high reproducibility for the proposed device. | Met: CVs less than 3% were obtained for the proposed device. |
| Precision compared to Predicate | Proposed device precision comparable to or better than predicate device. | Met: The predicate device (Dade Thromboplastin C Plus) showed CVs less than 4% for within-run and between-run precision, while the proposed device achieved CVs less than 3%, indicating superior or equivalent precision. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state a numerical sample size for the test set. It mentions "specimens from normal and abnormal patients, as well as samples from patients receiving OAC therapy."
The data provenance is not explicitly stated in terms of country of origin. However, the study was conducted at "two sites" using "multiple instruments," suggesting a multi-site correlation study. It is a retrospective clinical specimen study using collected patient samples.
3. Number of Experts and Qualifications for Ground Truth
Not applicable. This study focuses on the analytical performance and equivalence of a laboratory reagent rather than the diagnostic interpretation by experts. The "ground truth" here is the established measurement performance of the predicate device, not an expert's assessment of patient condition.
4. Adjudication Method
Not applicable, as this is an analytical performance study comparing a new reagent to a predicate, not a study involving expert review of diagnostic cases.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, an MRMC comparative effectiveness study was not done. This is not a diagnostic imaging or interpretation device that would involve human readers.
6. Standalone (Algorithm Only) Performance
Yes, the performance is essentially "standalone" as it refers to the analytical performance of the regent itself when used on laboratory instruments, without human interpretive input beyond following the testing protocol. The correlation and precision metrics directly assess the reagent's performance.
7. Type of Ground Truth Used
The ground truth for this study is implicitly established by the performance of the legally marketed predicate device (Dade Thromboplastin C Plus). The acceptance criteria are based on demonstrating analytical equivalence (correlation, bias, precision) to this established gold standard in the PT testing domain.
8. Sample Size for the Training Set
The document does not explicitly mention a "training set" as this is an analytical validation study of a reagent, not a machine learning model. The samples described in section 2 ("specimens from normal and abnormal patients, as well as samples from patients receiving OAC therapy") served as the study set for performance evaluation.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As noted in section 8, there isn't a "training set" in the context of a machine learning model. The principle of ground truth in this study is the analytical results obtained when testing samples with the predicate device, which is a widely accepted and legally marketed reagent.
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Premarket Notification 510(K) Thromboplastin D
8.0 PREMARKET NOTIFICATION 510(K) SUMMARY
| Applicant: | Laura A. Worfolk, Ph.D.Pacific Hemostasis11515 Vanstory DriveHuntersville, NC 28078(704) 875-0494 or (704) 948-3276Fax # (704) 875-2092 |
|---|---|
| Contact: | Same as above. |
| Date: | December 2, 1999 |
| Trade Name: | Pacific Hemostasis Thromboplastin D |
| Common Name: | Thromboplastin D |
| Classification Name: | Prothrombin Time Test, per 21 CFR section 864.7750 |
| Comparison Device: | Dade Thromboplastin C Plus, K901325 |
Description of the Device and Intended Use
Pacific Hemostasis Thromboplastin D is a lyophilized extract of rabbit brain thromboplastin containing calcium, stabilizer and buffer. Thromboplastin D 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).
Summary of Substantial Equivalence Comparisons
Pacific Hemostasis Thromboplastin D is substantially equivalent in intended use and performance to Dade Thromboplastin C Plus. Both the predicate device and the proposed product are formulated to detect deficiencies in factors II, V, VII and X (PT and PT-based factor assays). Further, both reagents can be used for monitoring oral anticoagulant (OAC) therapy. In correlation studies, PT testing of specimens from normal and abnormal patients, as well as samples from patients receiving OAC therapy were tested using both reagents. PT testing at two sites on multiple instruments yielded correlation coefficients ranging from 0.96-0.97 ( R ) and slopes ranging from 0.74-0.85. The bias was eliminated when the results were converted to INR, with correlation coefficients obtained ranging from 0.95-0.97 and slope values between 0.98-1.04. Within-run and between-run precision studies were also performed and CV's less than 3% were obtained for the proposed device, and less than 4% for the predicate device.
In summary, the identical intended use, similar technological characteristics and the performance data provided in this premarket notification demonstrate that Pacific Hemostasis Thromboplastin D is substantially equivalent to Dade Thromboplastin C Plus.
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around it. Inside the circle is a stylized symbol that resembles a bird or a human figure with outstretched arms, composed of three curved lines.
FEB 1 8 2000
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Laura A. Worfolk, Ph.D. Principal Scientist Pacific Hemostasis 11515 Vanstory Drive, Suite 125 Huntersville, North Carolina 28078-8144
Re: K994100 Trade Name: Pacific Hemostasis Thromboplastin D Regulatory Class: II Product Code: GJS Dated: February 3, 2000 Received: February 4, 2000
Dear Dr. Worfolk:
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 reguirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations. Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS 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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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 regulation (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" (21CFR 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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Page__________________________________________________________________________________________________________________________________________________________________________
510(k) Number (if known): 5994/00
Device Name:
Indications For Use:
Pacific Hemostasis Thromboplastin D is intended for use for performing the one-stage Prothrombin Time test (PT) and PT-based factor assays.
Peter E. Mapes
(Division Sign-Off) (Division of Clinical Laboratory Devices 510(k) Number -
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use_
(Optional Format 1-2-96)
§ 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).