← Product Code [GMP](/submissions/MI/subpart-d%E2%80%94serological-reagents/GMP) · K980638

# ADI SYPHILIS RPR LIQUID CONTROLS (K980638)

_Ampcor Diagnostics, Inc. · GMP · Jul 6, 1998 · Microbiology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/MI/subpart-d%E2%80%94serological-reagents/GMP/K980638

## Device Facts

- **Applicant:** Ampcor Diagnostics, Inc.
- **Product Code:** [GMP](/submissions/MI/subpart-d%E2%80%94serological-reagents/GMP.md)
- **Decision Date:** Jul 6, 1998
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 866.3820
- **Device Class:** Class 2
- **Review Panel:** Microbiology

## Indications for Use

Ampcor RPR control kit is designed as an unassayed control material to monitor the precision of AMPCOR RPR (Carbon-Particle) Liquid Reagent or other RPR tests at three reaction levels.

## Device Story

ADI Syphilis RPR Liquid Controls serve as quality control material for RPR diagnostic assays. The device consists of liquid reagents provided at three distinct reaction levels to monitor test precision. Used in clinical laboratory settings by laboratory technicians or medical technologists. The controls are processed alongside patient samples in RPR testing workflows; results allow the operator to verify assay performance and ensure the reliability of patient test outcomes. By monitoring precision, the device helps maintain the accuracy of syphilis screening and diagnostic procedures.

## Clinical Evidence

No clinical data provided; bench testing only.

## Technological Characteristics

Liquid control material formulated for RPR (Rapid Plasma Reagin) testing. Provided at three reaction levels for monitoring assay precision. Non-automated, standalone diagnostic control.

## Regulatory Identification

Treponema pallidum nontreponemal test reagents are devices that consist of antigens derived from nontreponemal sources (sources not directly associated with treponemal organisms) and control sera (standardized sera with which test results are compared) used in serological tests to identify reagin, an antibody-like agent, which is produced from the reaction of treponema microorganisms with body tissues. The identification aids in the diagnosis of syphilis caused by microorganisms belonging to the genus Treponema and provides epidemiological information on syphilis.

## Submission Summary (Full Text)

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## JUL C 1698

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Raymond Miller Official Correspondent Ampcor Diagnostics, Inc. 603 Heron Drive, Bldg. 3 Bridgeport, NJ 08014

Re: K980638 Trade Name: ADI Syphilis RPR Liquid Controls Regulatory Class: II Product Code: GMP Dated: May 13, 1998

Received: May 14, 1998

Dear Mr. Miller:

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, 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 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 Autman

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

то

510(k) Number (if known): 4980638

Device Name: ADI Syphilis RPR Liquid Controls

Indications For Use:

Ampcor RPR control kit is designed as an unassayed control material to monitor the precision of AMPCOR RPR (Carbon-Particle) Liquid Reagent or other RPR tests at three reaction levels.

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

## Concurrence of CDRH, Office of Device Evaluation (ODE)

Woody Dubac

(Division Sign Off) Division of Clinical Laboratory Devices

510(k) Number K980638

Prescription Use (Per 21 CFR 801.109)

OR

Over-The-Counter Use

(Optional Format 1-2-96)

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