RAICHEM MULTI-ANALYTE CALIBRATOR

K012250 · Hemagen Diagnostics, Inc. · JIX · Sep 24, 2001 · Clinical Chemistry

Device Facts

• Record ID: K012250
• Device Name: RAICHEM MULTI-ANALYTE CALIBRATOR
• Applicant: Hemagen Diagnostics, Inc.
• Product Code: JIX · Clinical Chemistry
• Decision Date: Sep 24, 2001
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 862.1150
• Device Class: Class 2

Intended Use

Mult-Analyte Serum Calibrator is used for the calibration of clinical chemistry assays. The material is well suited for automated analyzers.

Device Story

RAICHEM Multi-Analyte Calibrator is a serum-based material used to calibrate clinical chemistry assays on automated analyzers. It serves as a reference standard to ensure accuracy and consistency of clinical chemistry test results. Used in clinical laboratory environments by laboratory technicians and medical professionals. The calibrator is processed by the analyzer to establish a calibration curve, which is then applied to patient sample measurements to determine analyte concentrations. This process ensures the reliability of diagnostic testing, aiding in clinical decision-making.

Clinical Evidence

Bench testing only.

Technological Characteristics

Serum-based multi-analyte calibrator; liquid or lyophilized form factor; designed for use with automated clinical chemistry analyzers; no specific materials or software algorithms described.

Indications for Use

Indicated for the calibration of clinical chemistry assays in clinical laboratory settings using automated analyzers.

Regulatory Classification

Identification

A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)

Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.

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 border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with a bird-like shape formed by the negative space between the profiles.

Re:

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

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

SEP 2 4 2001

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

k012250 Trade/Device Name: RAICHEM® Multi-Analyte Calibrator Regulation Number: 21 CFR 862.1150 Regulation Name: Calibrator Regulatory Class: Class II Product Code: JIX Dated: July 16, 2001 Received: July 17, 2001

Dear 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 (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) that do not require approval of a premarket approval application (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 such 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.

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.

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

Page 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 regulation (21 CFR Part 801 and i 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" (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 [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Steven Gutman

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

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

## Attachment 2

## INDICATIONS FOR USE STATEMENT

**510(K) Number** K012250

Device Name: RAICHEM® Multi-Analyte Calibrator

Indications for Use: Mult-Analyte Serum Calibrator is used for the calibration of clinical chemistry assays. The material is well suited for automated analyzers.

(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) | |
|---------------------------------------|--|
|---------------------------------------|--|

OR

| Over-The-Counter-Use | |
|----------------------|--|
|----------------------|--|

(Division Sign-Off)

Division of Clinical Laboratory Devices

| 510(k) Number | K012250 |
|---------------|---------|
|---------------|---------|