The Coag-A-Mate MAX is a fully automated hemostasis instrument capable of performing coagulation assays that utilize photo-optical detection end point methodology.
The Coag-A-Mate MAX is a fully automated coagulation system with the capability of performing coagulation assays that utilize photo-optical end point detection methodology. These assays include Screening Assays such as PT, APTT, and TT; Quantitative Clot Based Assays such as Factor VIII and Factor X, Clauss Fibrinogen and Derived PT Fibrinogen; and Colorimetric Assay such as ATIII and Heparin Xa.

Device Description

The Coag-A-Mate MAX is a fully automated hemostasis instrument capable of performing coagulation assays that utilize photo-optical detection end point methodology.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Organon Teknika Corporation Coag-A-Mate MAX Coagulation System, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the demonstration of "substantial equivalence" to predicate devices, specifically the Organon Teknika MDA-180 and/or Coag-A-Mate MTX. The key metric for acceptance is a high correlation coefficient (r-value) and minimal bias in method comparison studies.

Acceptance Criteria (Implicit)	Reported Device Performance (Coag-A-Mate MAX)
Clot Based Assays (Screening: PT, APTT, TT): Substantially equivalent to predicate device (MDA 180) with high correlation and minimal bias.	Comparisons were highly correlated (r values of 0.978 to 0.994) in the presence of minimal bias.
Clot Based Assays (Quantitative: Fibrinogen, PT Derived Fibrinogen, Factor X, Factor VIII): Substantially equivalent to predicate device (MDA 180 and/or CAM MTX) with high correlation and minimal bias.	Comparisons were highly correlated (r values of 0.976 to 0.993) in the presence of minimal bias. Reportable Ranges Established: - PT Factor X Assay: 4.39% - 158% (values above 93% extrapolated) - APTT Factor VIII Assay: 7.8% - 23.1.1% (values above 87% extrapolated) - Fibrinogen Assay: 110.1 mg/dl - 759.15 mg/dl (values above 494 mg/dl extrapolated – note: original text has a typo, likely meant to say "values above 494 mg/dl were extrapolated for PT Derived Fibrinogen") - PT Derived Fibrinogen Assay: 131.3 mg/dl (values above 494 mg/dl extrapolated)
Colorimetric Assays (Chromogenic: Heparin Anti Xa, ATIII): Substantially equivalent to predicate device (MDA 180) with high correlation and minimal bias.	Method comparisons were highly correlated (r value of 0.979 and 0.992) in the presence of minimal bias.
Overall Comparison: Performance comparable to predicate devices and typical of photo-optical coagulation systems.	For clotting assays correlation coefficients ranged from 0.978 to 0.994, for Factor Assays correlation coefficients ranged from 0.976 to 0.993, and for chromogenic assays correlation coefficients were 0.979 to 0.992.

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify the sample size used for the test set. It also does not explicitly state the country of origin of the data or whether the studies were retrospective or prospective. It only refers to "comparison data" for establishing reportable ranges.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This information is not provided in the document. The studies described are method comparison studies comparing the new device against existing predicate devices, which act as the reference method rather than expert-established ground truth in a diagnostic sense.

4. Adjudication Method for the Test Set

This information is not applicable or provided. The studies are described as method comparisons, not requiring expert adjudication of results.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A MRMC comparative effectiveness study was not conducted or described. This type of study is more relevant for imaging or interpretative diagnostics where human readers evaluate cases with and without AI assistance. This device is a coagulation system, which performs automated measurements.

6. Standalone (Algorithm Only) Performance Study

Yes, the studies described are standalone performance studies of the Coag-A-Mate MAX system. The device's performance (measurements of coagulation assays) is compared directly to predicate devices (MDA-180 and Coag-A-Mate MTX) without human interaction influencing the measurement results beyond sample handling.

7. Type of Ground Truth Used

The "ground truth" for these studies is the results obtained from the predicate devices (Organon Teknika MDA-180 and Coag-A-Mate MTX). The studies are essentially method comparison studies, where the new device's measurements are correlated with those of the established, legally marketed predicate devices.

8. Sample Size for the Training Set

This information is not provided in the document. The filing describes performance studies for regulatory approval, not the internal development or training of an AI algorithm. If this device did incorporate AI (which is not explicitly stated but could be inferred from "automated hemostasis instrument" and "photo-optical detection"), the training data details are not included. However, given the date (1999) and nature of the device (coagulation system), it's more likely to rely on rule-based algorithms or calibrated physical principles rather than machine learning models requiring large training sets in the modern sense.

9. How the Ground Truth for the Training Set Was Established

This information is not provided, and as noted above, a "training set" in the context of modern AI/ML might not be applicable here. If calibration data was used for the device's internal algorithms, the method for establishing that calibration or "ground truth" is not detailed.

Summary

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K 99/101

JUN

510(k) Premarket Notification Organon Teknika Corporation Coag-A-Mate MAX Coagulation System 510(k) Summary Organon Teknika Corporation Coag-A-Mate MAX Coagulation System

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The submitter's name, address, telephone number, a contact person, and the date the (a)(1) summary was prepared;
Submitter's Name: Organon Teknika Corporation

Submitter's Address: 100 Akzo Avenue Durham, North Carolina 27712

Submitter's Telephone: (919) 620-2288

Submitter's Contact: Rebecca A. Rivas

Date 510(k) Summary Prepared: March 31, 1999

The name of the device, including the trade or proprietary name if applicable, the common (a)(2) or usual name, and the classification name, if known;
Trade or Proprietary Name: Coag-A-Mate MAX Coagulation System Common or Usual Name: Coagulation System

Classification Name: Coagulation Instrument

An identification of the legally marketed device to which the submitter claims substantial (a)(3) equivalence;
Device Equivalent to: Organon Teknika MDA- 180 Organon Teknika Coag-A-Mate MTX
A description of the device. (a)(4)
Device Description: The Coag-A-Mate MAX is a fully automated hemostasis instrument capable of performing coagulation assays that utilize photo-optical detection end point methodology.
A statement of the intended use of the device. (a)(5)
Device Intended Use: The Coag-A-Mate MAX is a fully automated hemostasis instrument capable of performing coagulation assays that utilize photo-optical detection end point methodology.

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510(k) Premarket Notification Organon Teknika Corporation Coag-A-Mate MAX Coagulation System

(a)(6)	A summary of the technological characteristics of the new device in comparison to those of the predicate device.
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FEATURES	Coag-A-Mate MAX	MDA – 180	Coag-A-MateMTX
Photo-Optical Detection	YES	YES	YES
Clotting Assays	YES	YES	YES
Chromogenic Assays	YES	YES	YES
Factor Assays	YES	YES	YES
Calibration	YES	YES	YES
Random Access	YES	YES	YES
User DefineableParameters	YES	YES	YES
Ancillary Components	Cuvette RacksPre-Dilution StripsCleaning SolutionKaolin SuspensionSyringe O-RingsReagent ContainersSyringe Plunger Tips	Test CuvettesBufferWash SolutionProbe CleanerReagent Containers	Test CuvettesCleaning SolutionProbe CleanerReagent Containers
Stat Mode Capability	YES	YES	YES

A brief discussion of the nonclinical tests submitted, referenced, or relied on in the (b)1) premarket notification submission for a determination of substantial equivalency. Clot Based Assays (Screening)

The PT, APTT and TT assay performance on the CAM MAX is substantially equivalent to the MDA 180. Comparisons were highly correlated (r values of 0.978 to 0.994) in the presence of minimal bias.

Clot Based Assays (Quantitative)

The Fibrinogen, PT Derived Fibrinogen, Factor X and Factor VIII assay performance on the CAM MAX is substantially equivalent to the MDA 180 and / or CAM MTX. Comparisons were highly correlated (r values of 0.976 to 0.993) in the presence of minimal bias. The reportable range for PT Factor X Assay based on the comparison data was established at 4.39% - 158%, vlues above 93% were extrapolated using a linear lease squares regression. The reportable range for APTT Factor VIII Assay based on the comparison data was established at 7.8% - 23.1.1%, values above 87% were extrapolated using a linear least square regression. The reportable range for Fibrinogen Assay based on the comparison data was established at 110.1 mg/dl - 759.15 mg/dl were extrapolated using a linear least square regression. The reportable range for PT Derived Fibrinogen Assay based on the comparison data was established at 131.3 mg/dl, values above 494 mg/dl were extrapolated using a linear least square regression.

Colormetric Assays (Chromogenic)

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510(k) Premarket Notification Organon Teknika Corporation Coag-A-Mate MAX Coagulation System

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The Heparin Anti Xa and ATIII assay performance on the CAM MAX is substantially equivalent to the MDA 180. Method comparisons were highly correlated (r value of 0.979 and 0.992) in the presence of minimal bias.

(b)3) The conclusions drawn from the testing demonstrating that the device is as safe, as effective, and performed as well or better than the legally marketed device identified in (a).

The Intended Use and Performance Characteristics of the Coag-A-Mate MAX are comparable to those of the predicate devices and typical of photo-optical coagulation systems in general. Comparison Studies demonstrate equivalence to the MDA-180 and the Coag-A-Mate MTX for the performance of in vitro coagulation studies. For clotting assays correlation coefficients ranged from 0.978 to 0.994, for Factor Assays correlation coefficients ranged from 0.976 to 0.993 and for chromogenic assays correlation coefficients were 0.979 to 0.992.

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510(k) Premarket Notification Organon Teknika Corporation Coag-A-Mate MAX Coagulation System PREMARKET NOTIFICATION

TRUTHFUL AND ACCURATE STATEMENT

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(As Required by 21 CFR 807.87 (j))

March 31, 1999

I certify that, in my capacity as, Regulatory Affairs Administrator, I believe to the best of my knowledge, that all data and information submitted in this premarket notification are truthful and accurate and that no material fact has been omitted.

Rebecca A. Lucas

Rebecca A. Rivas Organon Teknika Corporation 100 Akzo Avenue Durham, North Carolina 27712

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Image /page/4/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines representing its wings. The eagle's head is facing left. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle.

1 JUN

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Rebecca Rivas Regulatory Affairs Administrator Organon Teknika Corporation 100 Akzo Avenue Durham, N.C. 27712

Re: K991101 Trade Name: Coag-A-Mate® MAX Regulatory Class: II Product Code: GKP Dated: March 31, 1999 Received: April 1, 1999

Dear Ms. Rivas:

We have reviewed vour 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 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 Ouality 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 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 at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html"

Sincerely yours,

Steven Sutman

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) Premarket Notification Organon Teknika Corporation Coag-A-Mate MAX Coagulation System

Page

510(k) Number (If known): K99 | 10 |

Coag-A-Mate® MAX Device Name:

Indications For Usa:

The Coag-A-Mate MAX is a fully automated coagulation system with the capability of performing coagulation assays that utilize photo-optical end point detection methodology. These assays include Screening Assays such as PT, APTT, and TT; Quantitative Clot Based Assays such as Factor VIII and Factor X, Clauss Fibrinogen and Derived PT Fibrinogen; and Colorimetric Assay such as ATIII and Heparin Xa.

Peescription $\checkmark$

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation

Steve E. Mision

(Division Sign-Off)
Division of Clinical Laboratory Devices K991101
510(k) Number

్

Regulation Number and Section

§ 864.5400 Coagulation instrument.

(a)
Identification. A coagulation instrument is an automated or semiautomated device used to determine the onset of clot formation for in vitro coagulation studies.(b)
Classification. Class II (special controls). A fibrometer or coagulation timer intended for use with a coagulation instrument is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.