← Product Code [DHN](/productcode/DHN) · K012163

# POLYTITER SYSTEM (K012163)

_Polymedco, Inc. · DHN · Aug 20, 2001 · Immunology · SESE_

**Canonical URL:** https://fda-staging.innolitics.com/device/K012163

## Device Facts

- **Applicant:** Polymedco, Inc.
- **Product Code:** [DHN](/productcode/DHN.md)
- **Decision Date:** Aug 20, 2001
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 866.5100
- **Device Class:** Class 2
- **Review Panel:** Immunology

## Indications for Use

The PolyTiter Immunofluorescent Titration System including the calibrator solutions is designed to assist in the semiquantitative determination (titer/pattern) of the and no Te-aDiscRips System may be in the in vitro microscopic immuno-fluorescent assay. The PolyTiter System may be used as an aid in the diagnosis and management of autoimmune diseases.

## Device Story

PolyTiter Immunofluorescent Titration System is an in vitro diagnostic device used in clinical laboratory settings. It assists clinicians in determining titers and patterns for immunofluorescent assays. The system utilizes calibrator solutions to standardize the semiquantitative analysis of patient samples. By providing standardized titration results, the device aids healthcare providers in the diagnosis and management of autoimmune diseases. It is intended for prescription use only.

## Clinical Evidence

No clinical data provided; bench testing only.

## Technological Characteristics

In vitro diagnostic system for immunofluorescent titration; includes calibrator solutions; intended for microscopic assay analysis.

## Regulatory Identification

An antinuclear antibody immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the autoimmune antibodies in serum, other body fluids, and tissues that react with cellular nuclear constituents (molecules present in the nucleus of a cell, such as ribonucleic acid, deoxyribonucleic acid, or nuclear proteins). The measurements aid in the diagnosis of systemic lupus erythematosus (a multisystem autoimmune disease in which antibodies attack the victim's own tissues), hepatitis (a liver disease), rheumatoid arthritis, Sjögren's syndrome (arthritis with inflammation of the eye, eyelid, and salivary glands), and systemic sclerosis (chronic hardening and shrinking of many body tissues).

## Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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AUG 2 0 2001

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Helen Landicho, RAC Polymedco, Inc. 510 Furnace Dock Road, Cortlandt Manor, New York 10567

K012163 Re:

Trade Name: PolyTiter Immunofluorescent Titration System Regulation Number: 21 CFR § 866.5100 Regulatory Class: II Product Code: DHN Dated: July 6, 2001 Received: July 11, 2001

Dear Ms. Landicho:

We have reviewed your Section 510(k) notification of intent to market the device referenced we have reviewed your booms of substantially equivalent (for the indications for use above and we nave decommod the actected predicate devices marketed in interstate commerce stated in the encrosure) to regarly and date of the Medical Device Amendments, or to devices that provision in the roll be recordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls Cosment Act (Act. The general controls provisions of the Act include requirements for annual provisions of the rec. "The general smanufacturing 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 (Frediation Applovary, it may be oubject Code of Federal Regulations, Title 21, Parts 800 to 895. alloomig your ac 1100 vient determination assumes compliance with the Current Good A subscliming 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 mspoonoms, the Food and 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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This letter will allow you to begin marketing your device as described in your 510(k) premarket I site lotter will and in your ding 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 11 you desire spooline arin vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, (Joase contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrb/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

V

Enclosure

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510(k) submission

PolyTiter Immunofluorescent System

## SECTION 12.0 INDICATIONS FOR USE STATEMENT

510(k) NumberKO12163

Device Name: PolyTiter Immunofluorescent Titration System

Indications For Use:

The PolyTiter Immunofluorescent

Titration System including the calibrator solutions is designed to assist in the semiquantitative determination (titer/pattern) of the and no Te-aDiscRips System may be in the in vitro microscopic immuno-fluorescent assay. The PolyTiter System may be used as an aid in the diagnosis and management of autoimmune diseases. en al

C Donson

(Division Sign-Off)
Division of Clinical Laboratory Devices

510(k) Number K012163

(PLEASE NO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

V Prescription Use (Per 21 CFR 801.109) OR

## Over-The-Counter Use

Polymedco, Inc.

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**Source:** [https://fda-staging.innolitics.com/device/K012163](https://fda-staging.innolitics.com/device/K012163)

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