STA LIATEST CONTROL [N]+[P] KIT by AMERICAN BIOPRODUCTS CO.

The STA® Liatest® Control [N]+[P] kit is intended for use as control plasmas (Normal and Abnormal levels) for von Willebrand Factor (vWF) and D-dimer antigen assays by the immuno-turbidimetric method performed on STA® analyzers (Diagnostica Stago, France: STA® full-size model, K942117; STA® Compact model, K961579).

Device Description

The STA®-Liatest® Control [N]+[P] kit provides two citrated human plasmas intended for use as normal and abnormal controls for von Willebrand Factor (vWF) and D-dimer antigen assays by the immino-turbidimetric method performed on STA® analyzers (Diagnostic Stago, France: STA® full-size model and STA® Compact model).

Each STA®-Liatest® Control [N]+[P] kit provides 12 x 1-ml vials of freeze-dried human plasma containing vWF and D-dimer at normal levels (STA®-Liatest® Control [N]) and 12 x 1-ml vials of freeze-dried human plasma containing vWF and D-dimer at abnormal levels (STA®-Liatest® Control [P]).

Both the normal and abnormal plasmas in the freeze-dried state are stable for 24 months after the date of manufacture, when stored at 2°-8°C; after reconstitution with water, both plasmas are stable for 8 hours on board STA® analyzers.

AI/ML Overview

The provided text does not contain typical acceptance criteria and study results in the format expected for medical device performance evaluation. This document is a 510(k) Premarket Notification for a control kit (STA®-Liatest® Control [N]+[P] Kit), which is used to ensure the proper functioning of other assays, specifically for von Willebrand Factor (vWF) and D-dimer antigen.

For a control kit, "acceptance criteria" usually relate to the stability and consistency of the control material itself, rather than performance metrics like sensitivity, specificity, or AI accuracy that would be expected for a diagnostic device. The provided text describes the product, its intended use, and its stability.

Here's the breakdown of what can be extracted or inferred, and what is missing based on your requested format:

What can be inferred from the provided text:

Device: STA®-Liatest® Control [N]+[P] Kit
Intended Use: Normal and abnormal controls for vWF and D-dimer antigen assays by the immuno-turbidimetric method performed on STA® analyzers.
Purpose of the "Study" mentioned (implicitly): To demonstrate the stability of the control plasmas.

What is present regarding "Acceptance Criteria" (interpreted for a control kit):

Acceptance Criteria (Inferred from text)	Reported Device Performance (from text)
Stability (Freeze-dried state): Control plasmas should be stable for a specified duration at a given temperature.	24 months after the date of manufacture, when stored at 2°-8°C.
Stability (After reconstitution): Control plasmas should be stable for a specified duration after reconstitution.	8 hours on board STA® analyzers.

Missing Information (as per your request, because this is for a control kit, not a diagnostic device with AI):

The following points are not applicable or not provided in the context of this 510(k) submission for a control kit:

Sample size for the test set and data provenance: Not explicitly stated for performance validation. The "study" here is likely internal manufacturing/stability testing, not a clinical trial with a "test set" of patients.
Number of experts used to establish the ground truth for the test set and qualifications: Not applicable for a control kit. Ground truth for a control kit refers to the known concentrations of its analytes, established during manufacturing.
Adjudication method for the test set: Not applicable.
Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable. This kit controls human readers of an assay, it is not an AI algorithm assisting human readers.
Standalone (algorithm-only) performance: Not applicable, as this is a physical control substance, not an algorithm.
Type of ground truth used: For a control, the "ground truth" would be the assayed values of vWF and D-dimer established during manufacturing, possibly against a reference standard. The text doesn't specify how these were established.
Sample size for the training set: Not applicable. Control kits don't have "training sets."
How the ground truth for the training set was established: Not applicable.

In summary: The provided document is a regulatory approval for a control kit, not a performance study of a diagnostic device with AI. Therefore, most of your requested detailed study information is not available and not relevant to this specific type of device. The document primarily focuses on the product description and its stability claims.

Summary

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KA64716

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AMERICAN BIOPRODUCTS COMPANY Premarket 510(k) Notification STA®-Liatest® Control [N]+[P] Kit

JUN 2 6 1997

VII. Safety and Effectiveness Summary

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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 is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

00:10 26 pg

Andrew Loc B. Le., Ph.D. Director, Regulatory Affairs and Quality Assurance American BioProducts Company Five Century Drive Parsippany, New Jersey 07054

Re: K964716 STA®-Liatest® Control [N]+[P] Kit Regulatory Class: II Product Code: GGN Dated: April 24, 1997 Received: April 28, 1997

Dear Dr. Le:

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 requirement, 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 Requlations.

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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 labelinq 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" (21 CFR 807.97). Other qeneral 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 Gutman

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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510(k) Number (if known):

Device Name: STA® Liatest® Control [N]+[P] Kit

Indications for Use:

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number .	6964716

(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)

Over-The-Counter Use_

(Optional Format 1-2-96)

Regulation Number and Section

§ 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.