# K994035: Immunodip Urinary Albumin Screen, Model 790-01, 790-15

- Pathway: 510(k) (Traditional)
- Applicant: Diagnostic Chemicals, Ltd.
- Decided: Feb 1, 2000 after 64 days
- Product code: JIR (Indicator Method, Protein Or Albumin (Urinary, Non-Quant.))
- Device class: 1
- Regulation: 21 CFR 862.1645
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K951538 (1995). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K972337: Dclare Immunodip Stickfor Microalbuminuria, Diagnostic Chemicals, Ltd. (1997) Summary page 1.
- K922273: Array (R) 360, Beckman Instruments, Inc. (1992) Summary page 1.
- K934146: N-Assay Tia Microalbumin, Crestat Diagnostics, Inc. (1994) Summary page 1.
- K983113: Besure Plus One-Step Home Ovulation Predictor Kit, Syntron Bioresearch, Inc. (1998) Summary page 1.
- K991386: Early Ovulation Predictor (Stick), One Step Ovulation Predictor (Stick), Ovulation Predictor (Stick), Selfcare, Inc. (1999) Summary page 1.
- K960233: Miniclinic Ovulation Predictor, Vanguard Biomedical Corp. (1996) Summary page 1.
- K981271: Clearplan Easy Ovulation Test, Unipath, Ltd. (1998) Summary page 1.

## Indications for use
There are several kidney disease conditions that can produce high levels of albumin in urine (1). Determining albumin in the wine st the low levels measured by this test is helpful for sarly detection and trestment of pstients st risk for zenal (kidney) disease. Low but elevated ucinary albumin Jevels, or microalbuminuria, refees to a level of the human protein albumin in urine sbove about 18 mg/L. Levels above 18 mg/L are not normally found in heslthy individuals. These low but significant Isvels are not detectable with older dipstick assays. The ImmunoDip™ Urinary Albumin Screen classifies samples a5 positive or nepative based on their being above or below 2 level of 18 mg/L. Coaditions in Which elevated levels of albumin in urine may be present include: Type 1 and Type 2 diabetes (2-3), _hypertension (9, 10); and renal disease found in pregnancy (11). There aze other Jess common csusos as well. Diabetes is the largest single cause. One study found 45% of the insulin-dependent disbetics develop serious kidney disease (3). Testing for alevated levels of albumin in urine helps to identify those diabetics who are prone to kidney disease. Scisutific studies indicate that proper control of blood glucose (blood sugar) levels and blood pressure help slow or prevent kidney damage (1,9).

Source page: https://510kreport.com/device/K994035
Methodology: https://510kreport.com/methodology