MICROALBUMIN MULTI-CALIBRATOR SET

K042243 · Diagnostic Chemicals , Ltd. · JIX · Oct 4, 2004 · Clinical Chemistry

Device Facts

• Record ID: K042243
• Device Name: MICROALBUMIN MULTI-CALIBRATOR SET
• Applicant: Diagnostic Chemicals , Ltd.
• Product Code: JIX · Clinical Chemistry
• Decision Date: Oct 4, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1150
• Device Class: Class 2

Intended Use

For IN VITRO diagnostic use as a calibrator for the DCL Microalbumin Assay for quantitation of albumin in human urine. For Prescription Use Only

Device Story

The Microalbumin Multi-Calibrator Set is an in vitro diagnostic product used to establish reference points for the DCL Microalbumin Assay. It is intended for professional laboratory use to ensure accurate quantitation of albumin levels in human urine samples. By providing known concentration values, the calibrator allows the assay system to generate a standard curve, enabling the determination of albumin concentrations in patient specimens. This process supports clinical decision-making regarding renal function and the detection of microalbuminuria.

Clinical Evidence

No clinical data. Bench testing only. Stability validated via accelerated studies (12-month shelf life) and ongoing real-time studies. Value assignment validated using internal standards and recovery rates (1.00 +/- 0.03).

Technological Characteristics

Liquid solution calibrator set; 6 levels (1-300 mg/L). Human donor-derived material tested for HBsAG, HCV, and HIV. Traceable to Scripps Lab (Cat # A0213) Human Serum. Stability: 30 days opened at 2-8 °C; 12-month shelf life.

Indications for Use

Indicated for use as a calibrator in the DCL Microalbumin Assay for the quantitative measurement of albumin in human urine specimens.

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)

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Public Health Service

OCT 4 - 2004

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Nancy Olscamp Regulatory Affairs Coordinator, External, Diagnostic Division Diagnostic Chemicals Limited 16 McCarville Street Charlottetown, PE Canada CIE 2A6

Re: k042243 Trade/Device Name: Microalbumin Multi-Calibrator Set, Cat. No. SE-252 Regulation Number: 21 CFR 862.1150 Regulation Name: Calibrator Regulatory Class: Class II Product Code: JIX Dated: August 16, 2004 Received: August 19, 2004

Dear Ms. Olscamp:

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 [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Jean M. Cooper, M.S., DVM.

Tean 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 Health

Enclosure

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#### Diagnostic Chemicals Limi

510(K) Notification

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#### Microalbumin Multi-Calibrator Set

Product Cat. No. SE-2

# INDICATIONS FOR USE

11 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1

510(k) Number:

Device Name:

# Microalbumin Multi-Calibrator Set, Cat. No. SE-252

For IN VITRO diagnostic use as a calibrator for the DCL Microalbumin Assay for quantitation of albumin in human urine,

Indications for Use:

# PART 862--CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES

Subpart B -- Clinical Chemistry Test Systems

# Sec. 862.1150 Calibrator

- The DCL Microalbumin Multi-Calibrator Set, Cat. No. SE-252 is a device intended for medic: ldentification. (a) purposes for use in an albumin test system to establish points of reference that are used in th determination of values in the measurement of substances in human specimens.
- Classification. Class II. (b)

Prescription Use: (Part 21 CFR 801 Subpart D)

And/or

Over-the-Counter Use (OTC): (21 CFR 807 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)

Alfred S. A'
Division Sign-Off

Office of In Vitro Dia Device Evaluation and Safety

510(k) K04/2243