510(k) · Cleared
ClearedEzchek/Hba Blood Collection Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Flexsite Diagnostics, Inc. · LCP Assay, Glycosylated Hemoglobin
Cleared on Sep 5, 1997 as substantially equivalent to K861697 (Awareness Technology, Inc., 1986) after a 105-day review. Its family tree reaches back 1 generation to 1986. 11 later devices descend from it.
- Decided
- Sep 5, 1997
- Review
- 105 days
- Class
- Class II
- Product code
- LCP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K861697 (1986). 11 later devices descend from it, 6 citing it directly.
- Root · 1 generation backK861697 Self Assure/GHB (Capillary-Blood Collection Kit)Awareness Technology, Inc. · 1986
- This deviceK971919 Ezchek/Hba Blood Collection KitFlexsite Diagnostics, Inc. · 1997
- Descendant · cites it directly · 4 of its ownK984529 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 · cites it directly · 2 of its ownK983172 Accu-Base Hemoglobin A1C Sample Collection KitDiabetes Technologies, Inc. (Dti) · 1998
- Descendant · 2 generations on · 1 of its ownK993787 Appraise-Cardio Sample Collection KitOsborn Group, Inc. · 2000 · Recalled
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K984529Hemochek Sample Collection KitOsborn Laboratories, Inc. · 1999 · cites it directly4descendants
- K990899Hemochek-A1C Sample Collection KitOsborn Group, Inc. · 1999 · cites it directly3descendants
- K141944Home Access Aic TestHome Access Health Corp. · 2015 · 2 generations on2descendants
- K983172Accu-Base Hemoglobin A1C Sample Collection KitDiabetes Technologies, Inc. (Dti) · 1998 · cites it directly2descendants
- K993787Appraise-Cardio Sample Collection KitOsborn Group, Inc. · 2000 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K861697 | Self Assure/GHB (Capillary-Blood Collection Kit) | Awareness Technology, Inc. | 1986 | — |
| 0 (this device) | K971919 | Ezchek/Hba Blood Collection Kit | Flexsite Diagnostics, Inc. | 1997 | — |
| +1 | 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 | — |
| +1 | K983172 | Accu-Base Hemoglobin A1C Sample Collection Kit | Diabetes Technologies, Inc. (Dti) | 1998 | — |
| +2 | K993787 | Appraise-Cardio Sample Collection Kit | Osborn Group, Inc. | 2000 | 3 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 3 | 0 |
| 1999 | 3 | 0 |
| 2000 | 1 | 0 |
| 2002 | 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 |
|---|---|---|---|
| * | K861697 | Self Assure/GHB (Capillary-Blood Collection Kit)Summary page 1…ample Collection Kit Self-monitoring glycohemoglobin (hemoglobin A capillary blood collection kit. Glycosylated Hemoglobin Assay (21C.F.R. 864.7470) Self-Assure®/GHb; K861697/A. The device is a kit containing the materials required to collect a capillary blood sample from a finger-stick on a piece of f… | 1986 |
What descends from it? (11)
See all 116 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K984529 | Hemochek Sample Collection Kit | 1999 | 4 |
| K990899 | Hemochek-A1C Sample Collection Kit | 1999 | 3 |
| K983172 | Accu-Base Hemoglobin A1C Sample Collection Kit | 1998 | 2 |
| K974491 | Accu-Chek A1C Hemoglobin Test | 1998 | 1 |
| K991850 | Safe at-Home Test Kit for Monitoring Hemoglobin Alc | 1999 | 0 |
| K983253 | Precision A1C Home HBA1C Sample Collection Kit | 1998 | 0 |
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?
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?
For over-the-counter at home or doctor's office use to obtain a finger stick whole blood sample for laboratory testing to monitor jong-term (4-8 weeks) blood sugar control in diabetes. Test results should be evaluated together with a personal doctor. This product 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/K971919 · printed Nov 4, 2026
Cite this page
510(k) Report. “K971919: Ezchek/Hba Blood 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/K971919
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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