WAKO AUTOKIT MICRO ALBUMIN, WAKO AUTOKIT MICRO CALIBRATOR SET, MICRO ALBUMIN CONTROL SET

K030320 · Wako Chemicals USA, Inc. · JIS · Apr 11, 2003 · Clinical Chemistry

Device Facts

• Record ID: K030320
• Device Name: WAKO AUTOKIT MICRO ALBUMIN, WAKO AUTOKIT MICRO CALIBRATOR SET, MICRO ALBUMIN CONTROL SET
• Applicant: Wako Chemicals USA, Inc.
• Product Code: JIS · Clinical Chemistry
• Decision Date: Apr 11, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1150
• Device Class: Class 2

Intended Use

A urinary protein or albumin (nonquantitative) test system is a device intended to identify proteins or albumin in urine. Idetnification of urinary protein or albumin (nonquantitative) is used in the diagnosis and treatment of disease conditions such as renal or heart diseases or thyroid disorders, which are characterized by proteinuria or albuminuria.

Device Story

Wako Autokit Micro Albumin is an in vitro diagnostic assay for measuring albumin in urine. The device utilizes an immunoturbidimetric principle: patient urine samples are mixed with a buffer and anti-human albumin antibody (goat); albumin in the sample binds to the antibody to form insoluble aggregates, increasing solution turbidity. This turbidity is measured optically, with the signal intensity proportional to the albumin concentration. The assay is intended for clinical laboratory use to detect microalbuminuria, a marker for early diabetic nephropathy. Healthcare providers use the quantitative results to monitor diabetes control and assess the risk of progressive kidney damage. The device provides a minimum detectable level of 0.33 ug/dL.

Clinical Evidence

Bench testing only. Precision studies confirmed acceptable day-to-day performance. Comparison studies against the predicate device (Wako Micro Albumin B assay) yielded a correlation coefficient of 0.9984 and a regression equation of y = 1.0179x - 0.9619. The minimum detectable level is 0.33 ug/dL.

Technological Characteristics

Immunoturbidimetric assay. Reagents include buffer and goat anti-human albumin antibody. Optical measurement of turbidity proportional to albumin concentration. Standalone diagnostic reagent kit for use with clinical chemistry analyzers.

Indications for Use

Indicated for the identification of urinary protein or albumin in patients to assist in the diagnosis and treatment of disease conditions characterized by proteinuria or albuminuria, such as renal disease, heart disease, or thyroid disorders.

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.

Predicate Devices

• Wako Micro Albumin B assay

Submission Summary (Full Text)

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APR 1 1 2003

# Nako

## Wako Diagnostics

1600 Bellwood Road, Richmond, VA 23237 U.S.A.

K030320

### 510(k) Summary of Safety and Effectiveness

Diabetic nephropathy, which is accompanied by irreversible kidney damage and persistent proteinuria, is a major cause of death in persons with insulin-dependent diabctes mellitus and a main reason to initiate hemodialysis. Therefore, detection of kidney (glomerular) damage that is minimal and reversible is important. Microalbuminuria is a condition characterized by increased urinary excretion of albumin in the absence of overt nephropathy. It has been reported in several sludies to predict development of diabetic nephropathy and its mortality risk in both diabetes mellitus of insulin-dependent and non-insulin-dependent.

Because micro-albuminuria may be reversible if diabctes is well controlled, its early detection may be very beneficial in treatment programs for diabetes.

#### Principle of the method

When a sample is mixed with Buffer and Antibody, albumin in the sample combines specificaaly with anti-human albumin antibody (goat) in the Antibody to yeild an insoluble aggregate that causes increases turbidity in the solution. The degree of the turbidity of solution can be measured optically and is proportional to the concentration of albumin in the patient's sample.

Precision studies indicate acceptable values can be obtained on a day to day basis. The minimum detectable level of this method is estamiated to be 0.33 ug/dL. In comparison studies against the prodicate, Wako Micro Albumin B assay, a correlation cocfficient of 0.9984 and a regression cquation of y = 1.0179x - 0.9619 was obtained.

TELEPHONE [phone] FACSIMILE [phone] E-MAIL [e-mail] WEBSITE www.wakousa.com

A division of Wako Chernicals USA, Inc

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#### References:

Burtis, C.A. and Ashwood, E.R., Ed.: Tietz Textbook of Clinical Chemistry, 200 Ed., Sanuders, Philadelphia, 1994.

Lothar Thomas, M.D., Ed.: Clinical Laboratory Diagnostics DG Klinische Chemie Mitteilungen 26 (1995) page 5 Mount.J.N. : Journal of Clinical Pathology, 22, 12 (1986) Rosenstock, j. and Raskin, P .: Diabetes Care, 9, 529 (1986) Mogensen, Christensen, C.K. and Vittinghus, E .: Diabetes, 32 (Suppl.2), 64 (1983) Viberti, G.C. et al : Kidney International, 21, 714 (1982) Schmitz, A. and Vaeth, M. : Diabetic Medicine, 5, 126 (1988) Mogensen, C.E. et al : N.. Engl. J. Med., 311, 89 (1984) Mogensen, C.E.:N. Engl. J. Med., 310, 356 (1984)

Kuzellallory

---

Tonya Mallory, Executive Man
April 17, 2003

April 7, 2003 Wako Diagnostics Wako Chemicals USA, Inc. . 1600 Bellwood Road Richmond, VA 23237

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

APR 1 1 2003

Ms. Lori Creasy Regulatory Affairs Specialist Wako Diagnostics 1600 Bellwood Road Richmond, VA 23237

Re: k030320

> Trade/Device Name: Wako Autokit Micro Albumin Regulation Number: 21 CFR 862.1645 Regulation Name: Urinary protein or albumin (nonquantitative) test system Regulatory Class: Class II Product Code: JIS; JIQ; JJX Dated: January 29, 2003 Received: January 30, 2003

Dear Ms. Creasy:

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,

Steven Sutman

Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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K630320

## Indications for Use:

A urinary protein or albumin (nonquantitative) test system is a device intended to identify proteins or albumin in urine. Idetnification of urinary protein or albumin (nonquantitative) is used in the diagnosis and treatment of disease conditions such as renal or heart diseases or thyroid disorders, which are characterized by proteinuria or albuminuria.

Proprietary Name: Wako Autokit Micro Albumin

Established Registration Number: 1627434

Premarket Notification 510 (k) Number:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

OR

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

Sean Cooper

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K030320