IMMUNODIP URINARY ALBUMIN SCREEN ASSAY, CATALOGUE NUMBER 790-25

K022538 · Diagnostic Chemicals, Ltd. (Usa) · JIR · Aug 23, 2002 · Clinical Chemistry

Device Facts

• Record ID: K022538
• Device Name: IMMUNODIP URINARY ALBUMIN SCREEN ASSAY, CATALOGUE NUMBER 790-25
• Applicant: Diagnostic Chemicals, Ltd. (Usa)
• Product Code: JIR · Clinical Chemistry
• Decision Date: Aug 23, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1645
• Device Class: Class 1

Intended Use

For IN VITRO diagnostic use. There are several kidney disease conditions that can produce high levels of albumin in urine (1). Deternining alburnin in the urine at the low levels measured by this test is helpful for early detection and treatment of patients at risk for renal (kidney) disease. Low but clevated urinary albumin levels, or microalbuminuria, refers to a level of the human protcin albumin in urine above about 18 mg/L . Levels above 18 mg/L are not normally found in healthy individuals. These low but significant levels are not detectable with older dipstick assays. The ImmunoDip™ Urinary Albumin Test classifics samples as positive based on their boing above or below a level of 18 mg/L. Conditions in which clovated levels of albumin in urine may be present include: Type 1 and Type 2 diabetes (2-8): hypertension (9, 10); and renal disease found in pregnancy (11). There are other less common causes as well. Diabetes is the largest single cause. One study found 45% of the insulin-dependent diabetics develop serious kidney disease (3). Testing for elevated levels of albumin in urinc hclps to identify those diabetics who are prone to kidney disease. Scientific studics indicate that proper control of blood glucose (blood sugar) levels and blood pressure help slow or prevent kidney damage (1, 9).

Device Story

ImmunoDip™ Urinary Albumin Test is an in vitro diagnostic dipstick assay. It detects human albumin in urine samples. The device functions as a semi-quantitative test, classifying samples as positive or negative based on a threshold of 18 mg/L. It is designed to identify microalbuminuria, which is not detectable by traditional dipstick assays. The test is used by healthcare professionals to screen patients at risk for kidney disease, such as those with diabetes or hypertension. By identifying elevated albumin levels, the test assists clinicians in monitoring patients and implementing early interventions, such as blood glucose and blood pressure control, to slow or prevent the progression of renal damage.

Clinical Evidence

No clinical data provided. The document focuses on the diagnostic utility of detecting microalbuminuria (>18 mg/L) for early renal disease identification in high-risk populations.

Technological Characteristics

In vitro diagnostic dipstick assay for urinary albumin. Operates via immunochemical detection of albumin at a 18 mg/L threshold. Standalone, single-use manual test format.

Indications for Use

Indicated for in vitro diagnostic use to detect microalbuminuria (urinary albumin >18 mg/L) in patients at risk for renal disease, including those with Type 1 or Type 2 diabetes, hypertension, or pregnancy-related renal conditions.

Regulatory Classification

Identification

A urinary protein or albumin (nonquantitative) test system is a device intended to identify proteins or albumin in urine. Identification 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.

Submission Summary (Full Text)

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

AUG 2 3 2002

Mr. Mike Berg Diagnostic Chemicals Limited 2637 Eva Street Laguna Hills, CA 92656

k022538 Re: Trade/Device Name: ImmunoDip™ Urinary Albumin Test Regulation Number: 21 CFR 862.1645 Regulation Name: Urinary protein or albumin (nonquantitative) test system Regulatory Class: Class I Product Code: JIR Dated: July 30, 2002 Received: August 1, 2002

Dear Mr. Berg:

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 the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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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 1 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" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained 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/cdrb/dsmaldsmamain.html".

Sincerely yours,

Steven Butman

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): | K022538<br>and and and the commend of the first and the first and the first and the many of the may be any and the may be any and<br>Comments of Children Andrews of the Art Advanced Annual Comments |
|---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
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ImmunoDip™ Urinary Albumin Tost Device Name:

Indications for Use:

For IN VITRO diagnostic use.

There are several kidney disease conditions that can produce high levels of albumin in urine (1). Deternining alburnin in the urine at the low levels measured by this test is helpful for early detection and treatment of patients at risk for renal (kidney) disease. Low but clevated urinary albumin levels, or microalbuminuria, refers to a level of the human protcin albumin in urine above about 18 mg/L . Levels above 18 mg/L are not normally found in healthy individuals. These low but significant levels are not detectable with older dipstick assays. The ImmunoDip™ Urinary Albumin Test classifics samples as positive based on their boing above or below a level of 18 mg/L.

Conditions in which clovated levels of albumin in urine may be present include: Type 1 and Type 2 diabetes (2-8): hypertension (9, 10); and renal disease found in pregnancy (11). There are other less common causes as well. Diabetes is the largest single cause. One study found 45% of the insulin-dependent diabetics develop serious kidney disease (3). Testing for elevated levels of albumin in urinc hclps to identify those diabetics who are prone to kidney disease. Scientific studics indicate that proper control of blood glucose (blood sugar) levels and blood pressure help slow or prevent kidney damage (1, 9).

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## Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109

OR

Over-The-Counter Use

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(Division Sign-Off)

ivision Sion-Off Division of Clinical 510(k) Number

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