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 Description

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.

AI/ML Overview

The provided text describes a 510(k) summary for the "Wako Autokit Micro Albumin" device, which is a urinary protein or albumin (nonquantitative) test system. Here's a breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criterion	Reported Device Performance
Minimum Detectable Level	0.33 ug/dL
Correlation Coefficient (vs. predicate device)	0.9984
Regression Equation (vs. predicate device)	y = 1.0179x - 0.9619
Precision (day-to-day)	Acceptable values can be obtained

2. Sample size used for the test set and the data provenance

The document states "In comparison studies against the predicate, Wako Micro Albumin B assay". However, it does not specify the sample size used for these comparison studies. It also does not specify the country of origin of the data or whether the studies were retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided in the document. The comparison is made against a predicate device (Wako Micro Albumin B assay), implying the predicate device's results serve as the reference, but there's no mention of expert involvement in establishing ground truth for the test set.

4. Adjudication method for the test set

This information is not provided in the document.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

A multi-reader multi-case (MRMC) comparative effectiveness study was not performed or described. This device is an in-vitro diagnostic test for albumin measurement, not an AI-assisted diagnostic tool that would involve human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Yes, the performance reported (minimum detectable level, correlation, regression) represents the standalone performance of the Wako Autokit Micro Albumin device when quantitatively measuring albumin, likely through its optical turbidity measurement method. There is no human-in-the-loop component for the direct measurement reported.

7. The type of ground truth used

The ground truth for the comparison studies was established using results from a legally marketed predicate device, the "Wako Micro Albumin B assay". This implies a comparison to an established, presumably accurate, laboratory method.

8. The sample size for the training set

This information is not provided in the document. The device is a laboratory assay, not a machine learning algorithm that typically undergoes a training phase with a dedicated training set.

9. How the ground truth for the training set was established

This information is not applicable as the device is not a machine learning algorithm. If a "training set" were to refer to samples used during the development of the assay's reagents or method, the document does not elaborate on how ground truth for such samples would have been established.

Summary

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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

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 (877) 714-1924 FACSIMILE (804) 271-7791 E-MAIL diagnostics@wakousa.com 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 (301) 594-3084. 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 (301) 443-6597 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:

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)

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

Sean Cooper

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

Regulation Number and Section

§ 862.1150 Calibrator.

(a)
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.)(b)
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.