DCL MICROALBUMIN ASSAY, MODEL 252-20

K051191 · Diagnostic Chemicals , Ltd. · DCF · Jul 5, 2005 · Immunology

Device Facts

• Record ID: K051191
• Device Name: DCL MICROALBUMIN ASSAY, MODEL 252-20
• Applicant: Diagnostic Chemicals , Ltd.
• Product Code: DCF · Immunology
• Decision Date: Jul 5, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5040
• Device Class: Class 2

Intended Use

For the quantitative determination of low levels of albumin in urine. For IN VITRO diagnostic use.

Device Story

Microalbumin Assay is an in vitro diagnostic reagent kit for quantitative measurement of low-level albumin in urine samples. It utilizes an immunoturbidimetric assay format to detect albumin concentrations that are typically below the sensitivity limits of traditional protein assays. The assay is intended for use by laboratory professionals to identify microalbuminuria, which serves as an early clinical marker for glomerular disease and a predictor of nephropathy risk in patients with Type I diabetes. By enabling early detection, the assay supports clinical decision-making regarding diabetes management and treatment programs aimed at potentially reversing renal damage. The device provides quantitative results that assist clinicians in assessing patient renal health.

Clinical Evidence

No clinical data. Performance established via bench testing, including precision (NCCLS EP5-A), linearity (NCCLS EP6-P2), and interference studies (NCCLS EP7-P). Method comparison against predicate device (N=64) showed high correlation (r=0.9981).

Technological Characteristics

Immunoturbidimetric assay format. Designed for quantitative measurement of albumin (molecular weight 50,000) in urine. Reagent-based diagnostic system.

Indications for Use

Indicated for the quantitative determination of low levels of albumin in urine for in vitro diagnostic use. Used as an early indicator of glomerular disease and as a predictor of impending nephropathy in Type I diabetic patients.

Regulatory Classification

Identification

An albumin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the albumin (a plasma protein) in serum and other body fluids. Measurement of albumin aids in the diagnosis of kidney and intestinal diseases.

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 § 866.9.

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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**JUL 5 - 2005**

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Penny J. White Regulatory Affairs, Coordinator, External Diagnostic Chemicals Limited 16 McCarville Street Charlottetown, PE CIA 2E6

k051191 Re:

Trade/Device Name: Microalbumin Assay Regulation Number: 21 CFR 866.5040 Regulation Name: Albumin immunological test system Regulatory Class: Class II Product Code: DCF Dated: May 5, 2005 Received: May 10, 2005

Dear Ms. White:

We have reviewed your Section 510(k) premarket notification of intent to market the device w o nave reviewed your 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) rms lotter will anon " you we cognifinding of substantial equivalence of your device to a legally prematicated 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 or questions on the promie 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 Tou may other built beatherers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Carol C. Benam

Carol C. Benson, M.A. Acting 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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510(K) Notification

Diagnostic Chemicals Limited

Microalbumin Assay, Cat. No. 252-2

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## INDICATIONS FOR USE

510(k) Number (if known):

K05119.1.

Device Name:

Microalbumin Assay

Indications for Use:

For the quantitative determination of low levels of albumin in urine.

For IN VITRO diagnostic use.

Low levels of protein are normally excreted in the of healthy individuals. The uriniferous tubules and glomentifiter out m of these excreted mucoproteins. Albumin, a protein of molecular weight of 50,000, is not easily filtered out and small .1s are excreted into the urine. Increased excretion of albuminuria) is an early indicator of glomerular aı. disease (1,2).

Microalbuminuria is characterized by increased urinary excretion of albumin in the absence of overt nephropathy (3,4). Microalbumin is recognized as a strong predictor of impending nephropathy in Type I Diabetics and its mortality risk in diabetic patients (5). Early detection of microalbuminuria may be beneficial for treatment programs for diabetics because renal damage may be reversible if diabetes is well controlled at this stage.

Many of the methods traditionally used for measuring albumin lack the sensitivity and precision required for measuring microalbumin. The DCL Microalbumin Assay uses an immunoturbidimetric format which provides the sensitivity required for accurate determination of urinary microalbumin.

Prescription Use ---------V

AND/OR

Over the Counter Use

(Part 21 CFR 801 Subpart D)

(21 CFR 801 Subpart C)

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Concurrence of CDRH, Office of In Vitro Diagnostic Devices (IVD)
Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

Kos1191 510(k) __