510(k) · Cleared
ClearedImmunodip Urinary Albumin Screen, Model 790-01, 790-15
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Diagnostic Chemicals, Ltd. · JIR Indicator Method, Protein Or Albumin (Urinary, Non-Quant.)
Cleared on Feb 1, 2000 as substantially equivalent to K972337 (Diagnostic Chemicals, Ltd., 1997) and 6 other predicates after a 64-day review. Its family tree reaches back 2 generations to 1995.
- Decided
- Feb 1, 2000
- Review
- 64 days
- Class
- Class I
- Product code
- JIR
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 2 generations to K951538 (1995). 9 ancestors in all, the oldest K894579 (1989). No later device cites it as a predicate yet.
- Root · 2 generations backK951538 Besure One-=Step Home Ovulation Predictor KitSyntron Bioresearch, Inc. · 1995
- 1 generation backK983113 Besure Plus One-Step Home Ovulation Predictor KitSyntron Bioresearch, Inc. · 1998
- This deviceK994035 Immunodip Urinary Albumin Screen, Model 790-01, 790-15Diagnostic Chemicals, Ltd. · 2000
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K951538 | Besure One-=Step Home Ovulation Predictor Kit | Syntron Bioresearch, Inc. | 1995 | — |
| −1 | K983113 | Besure Plus One-Step Home Ovulation Predictor Kit | Syntron Bioresearch, Inc. | 1998 | — |
| 0 (this device) | K994035 | Immunodip Urinary Albumin Screen, Model 790-01, 790-15 | Diagnostic Chemicals, Ltd. | 2000 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1992 | 1 | 0 |
| 1994 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in JIR? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new JIR device
- #1 K210069 Minuteful - kidney testscore 7.5 · 4 generations · no Class I recall
- #2 Held for the reportin the report
What was it cleared against? (7)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K972337 | Dclare Immunodip Stickfor MicroalbuminuriaSummary page 1…ical Chemistrfi Classification Code- 75 JIR (Urinary Protein or Albumin) Predicate Devices: DCLare™ ImmunoDip™ stick for Microalbuminuria (Diagnostic Chemicals Limited- K972337), Microalbumin Assay/Array® Analyzer (Beckman Instruments Inc.- K922273), N-Assay TIA Microalbumin (Crestat Diagnostics/Kamiya B… | 1997 |
| * | K922273 | Array (R) 360Summary page 1…Predicate Devices: DCLare™ ImmunoDip™ stick for Microalbuminuria (Diagnostic Chemicals Limited- K972337), Microalbumin Assay/Array® Analyzer (Beckman Instruments Inc.- K922273), N-Assay TIA Microalbumin (Crestat Diagnostics/Kamiya Biomedical Company- K934146), BeSure Plus OneStep Ovulation Prediction te… | 1992 |
| * | K934146 | N-Assay Tia MicroalbuminSummary page 1…als Limited- K972337), Microalbumin Assay/Array® Analyzer (Beckman Instruments Inc.- K922273), N-Assay TIA Microalbumin (Crestat Diagnostics/Kamiya Biomedical Company- K934146), BeSure Plus OneStep Ovulation Prediction test (Syntron Bioresearch, Inc, K983113), One Step Ovulation Predictor (Selfcare, In… | 1994 |
| * | K983113 | Besure Plus One-Step Home Ovulation Predictor KitSummary page 1….- K922273), N-Assay TIA Microalbumin (Crestat Diagnostics/Kamiya Biomedical Company- K934146), BeSure Plus OneStep Ovulation Prediction test (Syntron Bioresearch, Inc, K983113), One Step Ovulation Predictor (Selfcare, Inc.-K991386B MiniClinic Ovulation Predictor (Vanguard Biomedical- K960233), and Clea… | 1998 |
| * | K991386 | Early Ovulation Predictor (Stick), One Step Ovulation Predictor (Stick), Ovulation…Summary page 1…cs/Kamiya Biomedical Company- K934146), BeSure Plus OneStep Ovulation Prediction test (Syntron Bioresearch, Inc, K983113), One Step Ovulation Predictor (Selfcare, Inc.-K991386B MiniClinic Ovulation Predictor (Vanguard Biomedical- K960233), and Clearplan Easy Ovulation Test (Whitehall Labs- K981271). De… | 1999 |
| * | K960233 | Miniclinic Ovulation PredictorSummary page 1…ulation Prediction test (Syntron Bioresearch, Inc, K983113), One Step Ovulation Predictor (Selfcare, Inc.-K991386B MiniClinic Ovulation Predictor (Vanguard Biomedical- K960233), and Clearplan Easy Ovulation Test (Whitehall Labs- K981271). Device Description: ImmunoDip™ Urinary Albumin Screen is an immu… | 1996 |
| * | K981271 | Clearplan Easy Ovulation TestSummary page 1…One Step Ovulation Predictor (Selfcare, Inc.-K991386B MiniClinic Ovulation Predictor (Vanguard Biomedical- K960233), and Clearplan Easy Ovulation Test (Whitehall Labs- K981271). Device Description: ImmunoDip™ Urinary Albumin Screen is an immunochromatographic test strip which is encased in a plastic ho… | 1998 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 5 years and passes through 2 companies; a new generation was cleared every 3.4 years on median.
- None of the 9 ancestors has a recall.
How does its category compare?
All JIR devicesJIR Indicator Method, Protein Or Albumin (Urinary, Non-Quant.): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JIR
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · JIR
Too few JIR 510(k)s in any year since 2007 to give a median.
Recalls per year · JIR
2so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JIR
2in 2025
MAUDE reports naming product code JIR, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 1 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 0 | — | 0 | 1 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 9 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 4 |
| 2016 | 0 | — | 0 | 5 |
| 2017 | 0 | — | 0 | 2 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 2 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 2 |
| 2024 | 0 | — | 0 | 4 |
| 2025 | 0 | — | 0 | 2 |
| 2026 | 0 | — | 2 | — |
What is it indicated for?
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…
Read the full statement (211 words)
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).
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K994035 · printed Nov 5, 2026
Cite this page
510(k) Report. “K994035: Immunodip Urinary Albumin Screen, Model 790-01, 790-15.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K994035
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026