510(k) · Cleared
ClearedSafe at-Home Test Kit for Monitoring Hemoglobin Alc
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biosafe Laboratories, Inc. · LCP Assay, Glycosylated Hemoglobin
Cleared on Nov 26, 1999 as substantially equivalent to K971919 (Flexsite Diagnostics, Inc., 1997) after a 178-day review. Its family tree reaches back 2 generations to 1986.
- Decided
- Nov 26, 1999
- Review
- 178 days
- Class
- Class II
- Product code
- LCP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K861697 (1986). No later device cites it as a predicate yet.
- 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 deviceK991850 Safe at-Home Test Kit for Monitoring Hemoglobin AlcBiosafe Laboratories, Inc. · 1999
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) | K991850 | Safe at-Home Test Kit for Monitoring Hemoglobin Alc | Biosafe Laboratories, Inc. | 1999 | — |
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…ing Glycohemoglobin Blood Collection Kit Classification Name: Glycosylated Hemoglobin Assay (21 CFR 864.7470) EZCHEK/HBA Blood Collection Kit by Flexsite Diagnostics (#K971919), currently marketed by Becton Dickinson as the BD A/c At Home Test™ The device is a kit containing the materials necessary to c… | 1997 |
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 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.
- 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 Safe at-Home Test Kit for Hemoglobin Alc is intended as a home-use or office-use device for collection of capillary blood for in vitro diagnostic quantitative determination of hemoglobin Alc (glycosylated hemoglobin). The device will be used for monitoring long-term glucose control in people with diabetes. This kit is not indicated 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/K991850 · printed Nov 4, 2026
Cite this page
510(k) Report. “K991850: Safe at-Home Test Kit for Monitoring Hemoglobin Alc.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K991850
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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