CATACHEM, INC., BILE ACIDS REAGENTS AND/OR BILE ACIDS TEST KIT by CATACHEM, INC.

Catachem, Inc. Bile Acids assay is an In-Vitro diagnostic enzymatic assay for the quantitative determination of total bile acids in human serum. Measurement of bile acids in human serum, and increased reported levels are representative of specific liver disease. For In-Vitro diagnostic use only

Bile Acids Calibrator. (For In-Vitro diagnostic use only) The bile acids assay contains a calibrator designed for the calibration of the Bile Acids method.

Bile Acids Controls (For In-Vitro diagnostic use only) The bile acids assay also contains control Level-I and control Level-II. These controls are designed to monitor the performance of the Bile Acids assay.

Device Description

Not Found

AI/ML Overview

This looks like a 510(k) clearance letter for an In-Vitro Diagnostic (IVD) enzymatic assay for detecting bile acids in human serum. The document explicitly states it's for diagnostic use only.

Given the nature of the device (an IVD assay) and the provided text:

Acceptance Criteria & Reported Device Performance: These are typically found in the submission itself, not the clearance letter. The letter confirms substantial equivalence, which implies the device met performance criteria comparable to a predicate device. We cannot extract specific numerical acceptance criteria or performance metrics from this document.
Study Details: Information regarding sample size, data provenance, expert involvement, adjudication, MRMC studies, standalone performance, ground truth types, and training set details are all part of the underlying studies submitted for 510(k) clearance. This information is not present in the clearance letter or the "Indications for Use" statement.

Therefore, I cannot provide a detailed answer to your request based solely on the provided text. The provided document is a regulatory clearance letter, not a scientific study report.

What can be extracted from the document related to the device:

Device Name: BILE ACIDS (Liquid Reagents)
Intended Use: In-Vitro diagnostic enzymatic assay for the quantitative determination of total bile acids in human serum.
Clinical Significance: Measurement of bile acids in human serum, and increased reported levels are representative of specific liver disease.
Components: Bile Acids Calibrator and Bile Acids Controls (Level-I and Level-II).
Regulatory Information:
- Regulation Number: 21 CFR 862.1177
- Regulation Name: Cholylglycine test system
- Regulatory Class: Class II
- Product Code: KWW, JIS, JJX
- 510(k) Number: K062503
- Predicate Device: The clearance letter states substantial equivalence to legally marketed predicate devices, but doesn't name them.

Summary

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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services, USA. The seal features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" are arranged in a circular pattern around the eagle. The seal is black and white.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Luis P. Leon, President CATACHEM, Inc. 955 Connecticut Avenue Suite No. 4106 Bridgeport, CT 06607

JAN 1 9 2007

K062503 Re:

Trade/Device Name: Bile Acids (Liquid Reagents) Regulation Number: 21 CFR 862.1177 Regulation Name: Cholylglycine test system Regulatory Class: Class II Product Code: KWW, JIS, JJX Dated: December 20, 2006 Received: December 26, 2006

Dear Mr. Leon:

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 Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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This letter will allow you to begin 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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0490. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address at http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Jean m. Cooper, M.S., D.V.M.

Yean M. Cooper, M.S., D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(K) Number (if Known): K062503

Device Name: BILE ACIDS

Bile Acids Calibrator. (For In-Vitro diagnostic use only) The bile acids assay contains a calibrator designed for the calibration of the Bile Acids method.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over The Counter use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Division Sign-Off

Office of In Vitm Diagnostic Device Evaluation and Safety

062503

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Regulation Number and Section

§ 862.1177 Cholylglycine test system.

(a)
Identification. A cholylglycine test system is a device intended to measure the bile acid cholylglycine in serum. Measurements obtained by this device are used in the diagnosis and treatment of liver disorders, such as cirrhosis or obstructive liver disease.(b)
Classification. Class II.