(162 days)
In vitro diagnostic reagent for the determination of the activity of coagulation factor V and for the detection of Factor V Leiden in citrated human plasma when used in conjunction with the Dade Behring ProC APC Method.
Coagulation Factor V Deficient Plasma is a lyophilized human plasma with a residual Factor V activity of less than or equal to 1% and contains activities of the remaining coagulation factors of more than 40%.
Here's a breakdown of the acceptance criteria and study information for the Dade Behring Coagulation Factor V Deficient Plasma based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria (from predicate) | Reported Device Performance (Dade Behring Coagulation Factor V Deficient Plasma) |
|---|---|---|
| Sensitivity (for Factor V Leiden detection) | 100% (from Coatest APC Resistance VS assay with V-Def Plasma) | 99% (when used with Dade Behring ProC APC assay) |
| Specificity (for Factor V Leiden detection) | 99% (from Coatest APC Resistance VS assay with V-Def Plasma) | 100% (when used with Dade Behring ProC APC assay) |
| Reproducibility (Precision) - Normal Sample | Not explicitly stated, implied to be comparable to predicate (Chromogenix V-Def Plasma) | 2.3% CV |
| Reproducibility (Precision) - Pathological Sample | Not explicitly stated, implied to be comparable to predicate (Chromogenix V-Def Plasma) | 4.9% CV |
| Residual Factor V activity | Not explicitly stated, implied to be comparable to predicate (Chromogenix V-Def Plasma) | ≤ 1% |
| Activities of remaining coagulation factors | Not explicitly stated, implied to be comparable to predicate (Chromogenix V-Def Plasma) | > 40% |
Note: The acceptance criteria for sensitivity and specificity are inferred from the performance of the predicate device (Coatest APC Resistance VS assay with V-Def Plasma) as reported in the comparative analysis. The other criteria are inherent properties of the device or evaluated against general precision expectations for such assays, aiming for substantial equivalence to the predicate.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 300 patient samples
- 88 samples from individuals with Factor V Leiden
- 212 samples from healthy blood donors
- Data Provenance: Not explicitly stated (e.g., country of origin). The study is retrospective, as it uses "patient samples" that imply they were collected prior to the study for testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. The text does not describe how the Factor V Leiden status or healthy status of the 300 patient samples was definitively established.
4. Adjudication Method for the Test Set
This information is not provided in the document.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance
This information is not applicable and not provided. The device is an in vitro diagnostic reagent, not an AI-assisted diagnostic tool that involves human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
This information is not applicable. The device is a diagnostic reagent, which inherently functions "stand-alone" in its chemical application, but its results are interpreted by human users within a clinical context. The "standalone" concept as typically applied to AI algorithms (algorithm-only performance) does not directly apply here. The study did evaluate the reagent's performance in detecting Factor V Leiden without human influence on the detection itself, but in conjunction with an "appropriate APC Resistance assay" (Dade Behring ProC APC assay).
7. The Type of Ground Truth Used
The ground truth for the test set appears to be clinical diagnosis or confirmed genetic status for Factor V Leiden and confirmed healthy status for the control group. The text mentions "88 Factor V Leiden samples" and "212 healthy blood donors," implying a pre-established "true" status for these samples, likely determined by a definitive genetic test for Factor V Leiden mutation or a clear health assessment.
8. The Sample Size for the Training Set
This information is not provided. The document describes a "comparative analysis" and a "reproducibility study," which are essentially validation or performance studies, not training. For an in vitro diagnostic reagent, the concept of a "training set" for an algorithm is generally not applicable in the same way it is for AI/machine learning. The reagent itself is formulated based on scientific principles, not "trained" on data.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as there is no "training set" in the context of an in vitro diagnostic reagent. The reagent's properties and composition (e.g., "residual Factor V activity of less than or equal to 1%" and "activities of the remaining coagulation factors of more than 40%") are established through manufacturing and quality control processes based on biochemical standards, not through a data-driven training process.
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1981709
Dade Behring
DADE BEHRING INC. P.O. Box 6101 Newark, DE 19714
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirement of SMDA 1990 and 21CFR 807.92.
Coagulation Factor V Deficient Plasma
Summary of Safety and Effectiveness
Coagulation Factor V Deficient Plasma is a Class II device and has a classification name of coagulation factor deficient plasma (21 CFR 864.7290 ). It is intended as an in vitro reagent for the determination of the activity of coagulation factor V, as indicated for the diagnosis of congenital or acquired Factor V deficiency states. When used with the Dade Behring ProC APC assay, the factor V deficient plasma is suitable for detecting Factor V Leiden mutation.
Coagulation Factor V Deficient Plasma is a lyophilized human plasma with a residual Factor V activity of less than or equal to 1% and contains activities of the remaining coagulation factors of more than 40%. This composition is similar to the Chromogenix V-Def Plasma, the predicate device, which consists of lyophilized human plasma deficient in Factor V. In addition, both deficient plasmas contain a heparin antagonist. When both reagents are used with an appropriate APC Resistance assay, highly sensitive determination of the Factor V Leiden mutation is possible.
Comparative Analysis: In a study of 300 patient samples (88 Factor V Leiden + 212 healthy blood donors), Coagulation Factor V Deficient Plasma used with the Dade Behring ProC APC assay yielded a specificity of 100% and a sensitivity of 99% for Factor V Leiden. In comparison, the Coatest APC Resistance VS assay (used with the V-Def Plasma) vielded a specificity of 99% and a sensitivity of 100% for Factor V Leiden.
Precision: A reproducibility study for Factor V was run on the Behring Coagulation Timer with samples in both normal and pathological ranges. Samples were run over a five day period with one run per day in replicates of eight. Precision data were calculated in a manner consistent with NCCLS Guideline EP5. The reproducibility study resulted in a 2.3% CV for the normal sample and 4.9% CV for the pathological sample.
Dade Behring considers the Coagulation Factor V Deficient Plasma to be substantially equivalent to the Chromogenix V-Def Plasma in terms of intended use, reagent composition and overall performance characteristics. When used with the Dade Behring ProC APC assay, sensitive determination of Factor V Leiden is possible.
Carolyn K. George
Carolyn K. George Manager, Regulatory Affairs, Biology
September 15, 1998
Date
510K
Summer
(Revis.
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Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle with three lines representing its wings or feathers. The eagle is positioned above a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES".
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
OCT 1 3 1998
Carolyn K. George Regulatory Affairs and Compliance Manager Dade Behring Inc. P.O. Box 6101 Newark, Delaware 19714
Re : K981709 Coagulation Factor V Deficient Plasma Requlatory Class: II Product Code: GJT September 15, 1998 Dated: Received: September 16, 1998
Dear Ms. George:
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 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 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 (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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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.
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 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/dsmamain.html".
Sincerely yours,
Steven Ditman
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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Indications Statement
Ravi
Ind.
Use
Device Name: Dade Behring Coagulation Factor V Deficient Plasma
Indications for Use: In vitro diagnostic reagent for the determination of the activity of coagulation factor V and for the detection of Factor V Leiden in citrated human plasma when used in conjunction with the Dade Behring ProC APC Method.
Carly K. George
Carolyn K. George Manger, Regulatory Affairs
September 15, 1998
Date
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Petul. Mauri.
Division of Clinical Laboratory Devices
510(k) Number K981709
510(k) Number
Division Sign-Off Office of Device Evaluation
prescription use
§ 864.7290 Factor deficiency test.
(a)
Identification. A factor deficiency test is a device used to diagnose specific coagulation defects, to monitor certain types of therapy, to detect coagulation inhibitors, and to detect a carrier state (a person carrying both a recessive gene for a coagulation factor deficiency such as hemophilia and the corresponding normal gene).(b)
Classification. Class II (performance standards).