510(k) · Cleared
ClearedHome Access Aic Test
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Home Access Health Corp. · LCP Assay, Glycosylated Hemoglobin
Cleared on Mar 13, 2015 as substantially equivalent to K990899 (Osborn Group, Inc., 1999) after a 239-day review. Its family tree reaches back 4 generations to 1986. 2 later devices descend from it.
- Decided
- Mar 13, 2015
- Review
- 239 days
- Class
- Class II
- Product code
- LCP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K861697 (1986). 2 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK861697 Self Assure/GHB (Capillary-Blood Collection Kit)Awareness Technology, Inc. · 1986
- 3 generations backK971919 Ezchek/Hba Blood Collection KitFlexsite Diagnostics, Inc. · 1997
- 2 generations backK984529 Hemochek Sample Collection KitOsborn Laboratories, Inc. · 1999
- 1 generation backK990899 Hemochek-A1C Sample Collection KitOsborn Group, Inc. · 1999 · Recalled
- This deviceK141944 Home Access Aic TestHome Access Health Corp. · 2015
- Descendant · cites it directly · 0 of its ownK231465 Q-Pad Test SystemQurasense · 2023
- Descendant · cites it directly · 0 of its ownK183230 OneDraw A1C Test SystemDrawbridge Health, Inc. · 2019
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K861697 | Self Assure/GHB (Capillary-Blood Collection Kit) | Awareness Technology, Inc. | 1986 | — |
| −3 | K971919 | Ezchek/Hba Blood Collection Kit | Flexsite Diagnostics, Inc. | 1997 | — |
| −2 | K984529 | Hemochek Sample Collection Kit | Osborn Laboratories, Inc. | 1999 | — |
| −1 | K990899 | Hemochek-A1C Sample Collection Kit | Osborn Group, Inc. | 1999 | 34 |
| 0 (this device) | K141944 | Home Access Aic Test | Home Access Health Corp. | 2015 | — |
| +1 | K231465 | Q-Pad Test System | Qurasense | 2023 | — |
| +1 | K183230 | OneDraw A1C Test System | Drawbridge Health, Inc. | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K990899 | Hemochek-A1C Sample Collection KitSummary page 4…ES Proprietary Name: HemoChek-A1c Sample Collection Kit (sold under the brand ReliOn A1c Test) 510(k) Number: K990899 Classification Name: Assay, glycosylated hemoglobin Regulation Number: 21 CFR §864.7470 Product Code:… | 1999 |
| † | K063852 | Accessa Cholesterol Panel | 2007 |
| † | K961274 | Olympus AU600 Clinical Chemistry Analyzer | 1996 |
| † | K031380 | Olympus HBA1C Reagent, (Catalog Number OSR6192), Olympus HBA1C Calibrator, (Catolog… | 2003 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 29 years and passes through 5 companies; a new generation was cleared every 11.0 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K231465 (Qurasense, 2023) has gone furthest, with 0 descendants of its own.
How does its category compare?
All LCP devicesLCP Assay, Glycosylated Hemoglobin: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
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 Home Access® A1C Test is an in vitro test method for the quantitative measurement of Hemoglobin Alc using capillary blood collected from the fingertip, collected onto filter paper via the Home Access collection cassette. The Home Access A1C Test is for measurement of HbAlc on blood specimens which can be collected at the patient's home or in a healthcare professional setting and delivered to the laboratory by mail. Measurements obtained through this method can be used for monitoring the long-term control of blood sugar (glucose) in people with diabetes.
This test is not to be used to diagnose or screen for diabetes. Not for use on neonates.
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/K141944 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141944: Home Access Aic Test.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141944
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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