RAICHEM ASSAYED CONTROL SERUM LEVEL 1 & 2

K031101 · Hemagen Diagnostics, Inc. · JJY · Jun 16, 2003 · Clinical Chemistry

Device Facts

• Record ID: K031101
• Device Name: RAICHEM ASSAYED CONTROL SERUM LEVEL 1 & 2
• Applicant: Hemagen Diagnostics, Inc.
• Product Code: JJY · Clinical Chemistry
• Decision Date: Jun 16, 2003
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Intended Use

The RAICHEM Assayed Control Serum is a general purpose chemistry control for use in monitoring the accuracy and precision of clinical chemistry assays..

Device Story

RAICHEM Assayed Control Serum Level 1 & 2 functions as a quality control material for clinical chemistry assays. It is used by laboratory professionals to monitor the accuracy and precision of analytical test systems. The device provides known values for specific analytes, allowing clinicians to verify that their diagnostic equipment is performing within established parameters. By comparing measured results against the provided assayed values, laboratories can identify potential systematic errors or instrument drift, ensuring reliable patient test results.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Assayed control serum; liquid or lyophilized form factor; intended for use with clinical chemistry analyzers; general purpose quality control material.

Indications for Use

Indicated for use as a general purpose chemistry control to monitor the accuracy and precision of clinical chemistry assays in a clinical laboratory setting.

Regulatory Classification

Identification

A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.

Submission Summary (Full Text)

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

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three human profiles incorporated into its body.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

FEB 2 6 2004

Mr. Jose A. Montanez Official Correspondent Hemagen Diagnostics, Inc. Raichem Division 9033 Red Branch Road Columbia, MD 21045

Re: k031101

> Trade/Device Name: RAICHEM® Assayed Control Serum Level 1 & 2 Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: Class I Product Code: JJY Dated: April 2, 2003 Received: April 15, 2003

Dear Mr. Montanez:

This letter corrects our substantially equivalent letter of June 16, 2003 regarding the Regulatory Class changing from II to I and the Product Code changing from JIX to JJY and the address changing from Dr. Edds to Mr. Montanez.

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent [{{or 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) that do not require approval of a premarket approval (PMA). 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 (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to continue marketing your device as described in your Section 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 Part 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]. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at their toll free number [phone] or at [phone] or at its Internet address http://www.fda.qov/cdrh/dsma/dsmamain.html.

Sincerely vours.

Carol C. Benson/or

Jean M. Cooper, MS. D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological He

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

## Attachment 2

## INDICATIONS FOR USE STATEMENT

510(K) Number K031101

Device Name: RAICHEM® Assayed Control Serum Level 1 & 2

Indications for Use: The RAICHEM Assayed Control Serum is a general purpose chemistry control for use in monitoring the accuracy and precision of clinical chemistry assays..

Stan Cooper

---

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K03110

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

concurrence of CDHR, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

: 小

OR

Over-The-Counter-Use _________________________________________________________________________________________________________________________________________________________