STAR AUTOMATED MULTI-PARAMETRIC ANALYZER

K983460 · American Bioproducts Co. · JPA · Nov 12, 1998 · Hematology

Device Facts

• Record ID: K983460
• Device Name: STAR AUTOMATED MULTI-PARAMETRIC ANALYZER
• Applicant: American Bioproducts Co.
• Product Code: JPA · Hematology
• Decision Date: Nov 12, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.5425
• Device Class: Class 2

Intended Use

STA-R® Automated Multi-Parametric Analyzer is a fully automatic laboratory analyzer for the performance of tests on human plasma the results of which aid in the diagnosis of coagulation abnormalities or in monitoring anticoagulant therapy.

Device Story

STA-R® is a fully automatic laboratory analyzer for coagulation testing; performs clot-based and photometric assays on human plasma samples. System automates sample handling, reagent delivery, analysis, and result reporting; features 'walk-away' capability. Central processing unit manages patient results, quality control, maintenance scheduling, and workload organization. Uses bar-coded reagents, calibrators, and controls for simplified management; supports manual entry for non-barcoded reagents. Operated by laboratory personnel in clinical settings. Provides automated diagnostic data to clinicians to assist in identifying coagulation disorders or adjusting anticoagulant therapy.

Clinical Evidence

Bench testing only. Performance demonstrated through validation of automated sample handling, reagent delivery, and analysis. Sample-to-sample carry-over was demonstrated to be undetectable.

Technological Characteristics

Fully automatic laboratory analyzer; performs clot-based and photometric assays at predetermined wavelengths. Features bar-code reader for reagents, calibrators, and controls. Central processing unit for system control and data management. Open system for adaptation of third-party reagents.

Indications for Use

Indicated for use in clinical laboratory settings to perform diagnostic tests on human plasma to aid in the diagnosis of coagulation abnormalities or to monitor anticoagulant therapy.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• STA® analyzer (K942117)

Submission Summary (Full Text)

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K983460

NOV 1 2 1998

## AMERICAN BIOPRODUCTS COMPANY Premarket 510(k) Notification STA-R® Automated Multi-Parametric Analyzer

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## SAFETY AND EFFECTIVENESS SUMMARY IX.

The STA-R® instrument is a fully automatic laboratory analyzer designed to perform tests which aid in the diagnosis of coagulation abnormalities or in monitoring anticoagulant therapy. Once test samples and reagents are loaded onto the instrument, sample handling, reagent delivery, analysis and reporting of test results are performed automatically, making the STA-R® instrument a true "walk-away" system. A central processing unit controls instrument functions, including management of patient results, quality control, scheduling of instrument maintenance and workload organization.

The instrument utilizes Diagnostica Stago (France) reagents, and is open to adaptation of other reagents currently commercially available from third-party manufacturers. Bar-coding of test reagents, calibrators and controls facilitates their use on the system and makes reagent management simple. Manual entry of reagent information enables the utilization of non barcoded reagents.

The instrument performs multiple test methodologies in random access (as selected by the user); these include clot-based tests and photometric assays at predetermined wavelengths.

Sample-to-sample carry-over has been demonstrated to be so low as to be undetectable.

The STA-R® instrument is substantially equivalent to the commercially available STA® analyzer, also from the same manufacturer (Diagnostica Stago, France), that received 510(k) clearance under K942117.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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 caduceus, which is a symbol of medicine, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular pattern around the caduceus. The caduceus is depicted in black and white, and the text is also in black.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

NOV 1 2 1998 Andrew Loc B. Le, Ph.D. Director, Regulatory Affairs and Quality Assurance American Bioproducts Company Five Century Drive Parsippany, New Jersey 07054

Re : K983460 STA-R® Automated Multiparametric Analyzer Trade Name: Requlatory Class: II Product Code: JPA Dated: September 30, 1998 Received: September 30, 1998

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 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, Druq, 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 aqainst 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 Requlations, 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 Druq Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory 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 obliqation 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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Paqe 2

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 requlation (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 requlation 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 [phone], 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 1 of 1

## Attachment A

510(k) Number (if known):_K983460

Device Name: STA-R® Automated Multi-Parametric Analyzer

Indications for Use:

STA-R® Automated Multi-Parametric Analyzer is a fully automatic 311 TV Tratomated for the performance of tests on human ellinear in the results of which aid in the diagnosis of coagulation abnormalities or in monitoring anticoagulant therapy.

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

| | (Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|-----------------------------------------|----------------------------------------------------------------------------------------|--|
| | <div> <img alt="Signature" src="signature.png"/> </div> <div>(Division Sign-Off)</div> | |
| Division of Clinical Laboratory Devices | | |
| 510(k) Number | K983460 | |

| Prescription Use | <div>✓</div> | OR | Over-The-Counter Use_ |
|----------------------|--------------|----|--------------------------|
| (Per 21 CFR 801.109) | | | (Optional Format 1-2-96) |