510(k) · Cleared
ClearedHemochek Sample Collection Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Osborn Laboratories, Inc. · LCP Assay, Glycosylated Hemoglobin
Cleared on Jan 28, 1999 as substantially equivalent to K971919 (Flexsite Diagnostics, Inc., 1997) after a 38-day review. Its family tree reaches back 2 generations to 1986. 4 later devices descend from it.
- Decided
- Jan 28, 1999
- Review
- 38 days
- Class
- Class II
- Product code
- LCP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K861697 (1986). 4 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK861697 Self Assure/GHB (Capillary-Blood Collection Kit)Awareness Technology, Inc. · 1986
- 1 generation backK971919 Ezchek/Hba Blood Collection KitFlexsite Diagnostics, Inc. · 1997
- This deviceK984529 Hemochek Sample Collection KitOsborn Laboratories, Inc. · 1999
- Descendant · cites it directly · 3 of its ownK990899 Hemochek-A1C Sample Collection KitOsborn Group, Inc. · 1999 · Recalled
- Descendant · 2 generations on · 2 of its ownK141944 Home Access Aic TestHome Access Health Corp. · 2015
- Descendant · 3 generations on · 0 of its ownK231465 Q-Pad Test SystemQurasense · 2023
- Descendant · 3 generations on · 0 of its ownK183230 OneDraw A1C Test SystemDrawbridge Health, Inc. · 2019
Most influential descendants
Showing 4 of 4 · See all- K990899Hemochek-A1C Sample Collection KitOsborn Group, Inc. · 1999 · cites it directly3descendants
- K141944Home Access Aic TestHome Access Health Corp. · 2015 · 2 generations on2descendants
- K231465Q-Pad Test SystemQurasense · 2023 · 3 generations on0descendants
- K183230OneDraw A1C Test SystemDrawbridge Health, Inc. · 2019 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K861697 | Self Assure/GHB (Capillary-Blood Collection Kit) | Awareness Technology, Inc. | 1986 | — |
| −1 | K971919 | Ezchek/Hba Blood Collection Kit | Flexsite Diagnostics, Inc. | 1997 | — |
| 0 (this device) | K984529 | Hemochek Sample Collection Kit | Osborn Laboratories, Inc. | 1999 | — |
| +1 | K990899 | Hemochek-A1C Sample Collection Kit | Osborn Group, Inc. | 1999 | 34 |
| +2 | K141944 | Home Access Aic Test | Home Access Health Corp. | 2015 | — |
| +3 | K231465 | Q-Pad Test System | Qurasense | 2023 | — |
| +3 | K183230 | OneDraw A1C Test System | Drawbridge Health, Inc. | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2015 | 1 | 0 |
| 2019 | 1 | 0 |
| 2023 | 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 LCP? 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 LCP device
- #1 K221326 Nova Allegro HbA1c Assay, Nova Allegro Analyzerscore 9.6 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K971919 | Ezchek/Hba Blood Collection KitSummary page 1…d Hemoglobin Assay Predicate Device Equivalence: Substantial equivalence is claimed to the EZCHEK™/HbA1c Sample Collection Kit, cleared for commercial distribution per K971919. Device Description: The HemoChek Sample Collection Kit is a kit which is sent to the patient's home after the patient has bee… | 1997 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K990899 | Hemochek-A1C Sample Collection Kit | 1999 | 3 |
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 13 years and passes through 3 companies; a new generation was cleared every 11.0 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K990899 (Osborn Group, Inc., 1999) has gone furthest, with 3 descendants of its own.
- 5 other devices also cite its predicate K971919.
How does its category compare?
All LCP devicesLCP Assay, Glycosylated Hemoglobin: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LCP
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · LCP
269in 2019
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LCP
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LCP
22in 2025
MAUDE reports naming product code LCP, 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 | 7 | 133 | 1 | 5 |
| 2008 | 5 | 206 | 3 | 11 |
| 2009 | 6 | 158 | 6 | 15 |
| 2010 | 2 | — | 5 | 4 |
| 2011 | 10 | 176 | 51 | 27 |
| 2012 | 9 | 143 | 0 | 51 |
| 2013 | 2 | — | 4 | 193 |
| 2014 | 8 | 127 | 2 | 182 |
| 2015 | 3 | 239 | 2 | 64 |
| 2016 | 2 | — | 6 | 29 |
| 2017 | 5 | 218 | 1 | 149 |
| 2018 | 2 | — | 1 | 1,911 |
| 2019 | 4 | 269 | 0 | 114 |
| 2020 | 1 | — | 0 | 13 |
| 2021 | 0 | — | 0 | 7 |
| 2022 | 0 | — | 1 | 8 |
| 2023 | 2 | — | 0 | 27 |
| 2024 | 1 | — | 1 | 39 |
| 2025 | 0 | — | 1 | 22 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The HemoChek Sample Collection Kit is indicated for use in the measurement of HbA1c on blood specimens which can be collected at the patient’s home or at a physician’s office on a filter paper and delivered to the laboratory by mail. The HbA1c test is used in the assessment of the average blood glucose over an 8-12 week period. The results are to be evaluated by the patient's physician. The product is not indicted for the diagnosis of diabetes mellitus.
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/K984529 · printed Nov 4, 2026
Cite this page
510(k) Report. “K984529: Hemochek Sample Collection Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K984529
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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