BILIRUBIN, TOTAL AND DIRECT, PRODUCT NO, 122-01, 122-02, 122-03, 122-04

K991866 · A.P. Total Care, Inc. · CIG · Aug 2, 1999 · Clinical Chemistry

Device Facts

• Record ID: K991866
• Device Name: BILIRUBIN, TOTAL AND DIRECT, PRODUCT NO, 122-01, 122-02, 122-03, 122-04
• Applicant: A.P. Total Care, Inc.
• Product Code: CIG · Clinical Chemistry
• Decision Date: Aug 2, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1110
• Device Class: Class 2

Intended Use

The total and direct bilirubin reagents, product No. 122-01,122-02,122-03 and 122-04 are intended for Invitro Diagnostic use in the automated, quantitative determination of total and direct bilirubin in serum, or plasma.

Device Story

Device consists of chemical reagents for the quantitative measurement of total and direct bilirubin in serum or plasma samples. Used in clinical laboratory settings by trained personnel on automated chemistry analyzers. Reagents react with bilirubin in the sample to produce a measurable color change; intensity of color is proportional to bilirubin concentration. Results are used by clinicians to assess liver function and diagnose/monitor hepatobiliary disorders. Benefits include rapid, automated diagnostic information for patient management.

Clinical Evidence

No clinical data provided; device relies on bench testing and performance validation typical for in vitro diagnostic reagents.

Technological Characteristics

In vitro diagnostic chemical reagents for automated spectrophotometric analysis. Reagent-based colorimetric assay. No electronic components, software, or energy sources integral to the reagent kit itself; intended for use on standard automated clinical chemistry analyzers.

Indications for Use

Indicated for the in vitro diagnostic, automated, quantitative determination of total and direct bilirubin in human serum or plasma for clinical laboratory use.

Regulatory Classification

Identification

A bilirubin (total or direct) test system is a device intended to measure the levels of bilirubin (total or direct) in plasma or serum. Measurements of the levels of bilirubin, an organic compound formed during the normal and abnormal distruction of red blood cells, if used in the diagnosis and treatment of liver, hemolytic hematological, and metabolic disorders, including hepatitis and gall bladder block.

Submission Summary (Full Text)

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

AUG - 2 1999

A.P. Total Care, Inc. c/o Mr. Luis P. Leon Catachem, Inc. P.O. Box 6216 Bridgeport, Connecticut 06606

Re: K991866 Trade Name: Bilirubin, Total and Direct Regulatory Class: II Product Code: CIG Dated: May 27, 1999 Received: June 1, 1999

Dear Mr. Leon:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing 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 comply with the GMP regulation 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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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at [phone].

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 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"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone], or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely vours.

Steven Sutman

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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# 510 (k) NUMBER (IF KNOWN): K 99/8VA م

## DEVICE NAME: BILIRUBIN

#### (Total and Direct)

### IDICATIONS FOR USE:

The total and direct bilirubin reagents, product No. 122-01,122-02,122-03 and 122-04 are intended for Invitro Diagnostic use in the automated, quantitative determination of total and direct bilirubin in serum, or plasma.

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

Concurrence of CDRH, Office of Device Evaluation (OED)

**Prescription Use**
(Per 21 CFR 801.109

OR

Over-The-Counter-Use (Optional Format 1-2-96)