COAG-A-MATE MAX

K991101 · Organon Teknika Corp. · GKP · Jun 1, 1999 · Hematology

Device Facts

• Record ID: K991101
• Device Name: COAG-A-MATE MAX
• Applicant: Organon Teknika Corp.
• Product Code: GKP · Hematology
• Decision Date: Jun 1, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.5400
• Device Class: Class 2

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.

Device Story

Coag-A-Mate MAX is a fully automated hemostasis instrument for clinical laboratory use. It processes patient samples to perform coagulation assays using photo-optical detection end point methodology. The system supports clotting, chromogenic, and factor assays. It features random access and STAT mode capability. Operators (laboratory technicians) load samples and reagents into the system; the device automates the assay process, including calibration and measurement. Output consists of quantitative coagulation results, which clinicians use to assess patient hemostasis and guide clinical decision-making. The device benefits patients by providing rapid, automated diagnostic information for coagulation disorders.

Clinical Evidence

Bench testing only. Performance evaluated via method comparison studies against MDA-180 and Coag-A-Mate MTX. Clot-based screening assays (PT, APTT, TT) showed correlation coefficients of 0.978–0.994. Quantitative factor assays (Fibrinogen, PT Derived Fibrinogen, Factor X, Factor VIII) showed correlation coefficients of 0.976–0.993. Chromogenic assays (Heparin Anti Xa, ATIII) showed correlation coefficients of 0.979–0.992. Minimal bias reported across all comparisons.

Technological Characteristics

Fully automated hemostasis instrument; photo-optical detection principle; random access; supports clotting, chromogenic, and factor assays. Ancillary components include cuvette racks, pre-dilution strips, cleaning solution, kaolin suspension, syringe O-rings, reagent containers, and syringe plunger tips. Connectivity and software details not specified.

Indications for Use

Indicated for use as a fully automated coagulation system to perform coagulation assays including screening assays (PT, APTT, TT), quantitative clot-based assays (Factor VIII, Factor X, Clauss Fibrinogen, Derived PT Fibrinogen), and colorimetric assays (ATIII, Heparin Xa).

Regulatory Classification

Identification

A coagulation instrument is an automated or semiautomated device used to determine the onset of clot formation for in vitro coagulation studies.

Special Controls

*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.

Predicate Devices

• Organon Teknika MDA-180
• Organon Teknika Coag-A-Mate MTX

Submission Summary (Full Text)

{0}------------------------------------------------

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

ﺮ ﺍﻟﻤﺮ

- 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: [phone]

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.

{1}------------------------------------------------

## 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. |
|--------|------------------------------------------------------------------------------------------------------------------|
|--------|------------------------------------------------------------------------------------------------------------------|

ﻣﺜﺎ ﺮ

| FEATURES | Coag-A-Mate MAX | MDA – 180 | Coag-A-Mate<br>MTX |
|-------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------|---------------------------------------------------------------------------|
| 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 Defineable<br>Parameters | YES | YES | YES |
| Ancillary Components | Cuvette Racks<br>Pre-Dilution Strips<br>Cleaning Solution<br>Kaolin Suspension<br>Syringe O-Rings<br>Reagent Containers<br>Syringe Plunger Tips | Test Cuvettes<br>Buffer<br>Wash Solution<br>Probe Cleaner<br>Reagent Containers | Test Cuvettes<br>Cleaning Solution<br>Probe Cleaner<br>Reagent 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)

{2}------------------------------------------------

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

ﻬﻤﺎ ﻢ

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.

.

{3}------------------------------------------------

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

# TRUTHFUL AND ACCURATE STATEMENT

ﺎ ﻳﺮ ﺍﻟﻤﺮﺍﺟﻊ

(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

1

{4}------------------------------------------------

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.

{5}------------------------------------------------

#### Page 2

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 [phone].

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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or at [phone] 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

{6}------------------------------------------------

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

్