(69 days)
Mult-Analyte Serum Calibrator is used for the calibration of clinical chemistry assays. The material is well suited for automated analyzers.
Not Found
This is a notification from the FDA regarding the 510(k) premarket notification for the RAICHEM® Multi-Analyte Calibrator. The document states that the device is substantially equivalent to legally marketed predicate devices and can be marketed subject to general controls.
The document does not contain any information about acceptance criteria, device performance, results of a study, sample sizes, data provenance, expert qualifications, ground truth establishment, or any comparative effectiveness studies.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided text. The document is a regulatory approval letter, not a scientific study report.
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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.
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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 (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" (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/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
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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 |
|---|---|
| --------------- | --------- |
§ 862.1150 Calibrator.
(a)
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.)(b)
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.