510(k) · Cleared
ClearedHemochek Urine Collection Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Osborn Group, Inc. · JIQ Turbidimetric Method, Protein Or Albumin (Urinary, Non-Quant.)
Cleared on Sep 24, 1999 as substantially equivalent to K984361 (Osborn Laboratories, Inc., 1999) and 1 other predicate after a 121-day review. Its family tree reaches back 3 generations to 1997.
- Decided
- Sep 24, 1999
- Review
- 121 days
- Class
- Class I
- Product code
- JIQ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K970357 (1997). 5 ancestors in all, the oldest K800947 (1980). No later device cites it as a predicate yet.
- Root · 3 generations backK970357 EpiscreenEpitope, Inc. · 1997
- 2 generations backK973395 Episcreen Oral Specimen Collection DeviceEpitope, Inc. · 1998
- 1 generation backK984361 Oral-Eze Oral Fluid Collection SystemOsborn Laboratories, Inc. · 1999 · Recalled
- This deviceK991800 Hemochek Urine Collection KitOsborn Group, Inc. · 1999
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K970357 | Episcreen | Epitope, Inc. | 1997 | — |
| −2 | K973395 | Episcreen Oral Specimen Collection Device | Epitope, Inc. | 1998 | — |
| −1 | K984361 | Oral-Eze Oral Fluid Collection System | Osborn Laboratories, Inc. | 1999 | 1 |
| 0 (this device) | K991800 | Hemochek Urine Collection Kit | Osborn Group, Inc. | 1999 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1995 | 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 JIQ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K984361 | Oral-Eze Oral Fluid Collection SystemSummary page 1…oup, Inc. Oral-Eze™ Oral Fluid Collection System (primary predicate device) and the Sage Products Inc. Midstream Collection Kit , cleared for commercial distribution per K984361and K800947, respectively. Device Description: The HemoChek Urine Collection Kit is a device used by a person under the supervis… | 1999 |
| * | K800947 | Midstream Collection KitSummary page 1…ral-Eze™ Oral Fluid Collection System (primary predicate device) and the Sage Products Inc. Midstream Collection Kit , cleared for commercial distribution per K984361and K800947, respectively. Device Description: The HemoChek Urine Collection Kit is a device used by a person under the supervision of a tr… | 1980 |
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 2 years and passes through 3 companies; a new generation was cleared every 11 months on median.
- 1 of the 5 ancestors has a recall of any class.
How does its category compare?
All JIQ devicesJIQ Turbidimetric Method, Protein Or Albumin (Urinary, Non-Quant.): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · JIQ
1in 2014
2026 to Oct 25, outlined.
Median 510(k) review, days · JIQ
Too few JIQ 510(k)s in any year since 2007 to give a median.
Recalls per year · JIQ
1in 2012
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JIQ
9in 2025
MAUDE reports naming product code JIQ, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 1 |
| 2012 | 0 | — | 1 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 3 |
| 2025 | 0 | — | 0 | 9 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The HemoChek Urine Collection Kit is a prescription device intended to collect a urine specimen in midstream or by dipping the absorbent pad in a cup containing urine, contain the specimen, and preserve the specimen after collection and during mailing from the collection area to the laboratory for testing of creatinine and microalbumin concentrations.
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/K991800 · printed Nov 6, 2026
Cite this page
510(k) Report. “K991800: Hemochek Urine Collection Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K991800
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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