510(k) · Cleared
ClearedAccu-Chek A1C Hemoglobin Test
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Boehringer Mannheim Corp. · LCP Assay, Glycosylated Hemoglobin
Cleared on May 13, 1998 as substantially equivalent to K934070 (Boehringer Mannheim Corp., 1994) and 1 other predicate after a 166-day review. Its family tree reaches back 2 generations to 1986. 1 later device descends from it.
- Decided
- May 13, 1998
- Review
- 166 days
- Class
- Class II
- Product code
- LCP
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K861697 (1986). 3 ancestors in all. 1 later device descends 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 deviceK974491 Accu-Chek A1C Hemoglobin TestBoehringer Mannheim Corp. · 1998
- Descendant · cites it directly · 0 of its ownK983253 Precision A1C Home HBA1C Sample Collection KitMedisense, Inc. · 1998
Most influential descendants
Showing 1 of 1 · See all- K983253Precision A1C Home HBA1C Sample Collection KitMedisense, Inc. · 1998 · cites it directly0descendants
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) | K974491 | Accu-Chek A1C Hemoglobin Test | Boehringer Mannheim Corp. | 1998 | — |
| +1 | K983253 | Precision A1C Home HBA1C Sample Collection Kit | Medisense, Inc. | 1998 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 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? (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 |
|---|---|---|---|
| * | K934070 | Tina-Quant Hemoglobin A1CSummary page 1…Classification name: Glycosylated Hemoglobin Assay The device is an accessory to our Tina Quant Hemoglobin A, Assay. We claim our own device as the predicate device (#k934070). In addition, a secondary predicate device may be considered. The role of the Accu-Chek A;. Hemoglobin Test in the overall proc… | 1994 |
| * | K971919 | Ezchek/Hba Blood Collection KitSummary page 1…of the Accu-Chek A;. Hemoglobin Test in the overall process is substantially equivalent to the intended use of the Flexsite Diagnostics EZCHEK/HBA Blood Collection Kit (#k971919). The device is a kit containing the materials required to collect a whole blood sample on a test strip and mail it to a laborat… | 1997 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| 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?
- The line of descent spans 12 years and passes through 3 companies; a new generation was cleared every 11.0 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K983253 (Medisense, Inc., 1998) has gone furthest, with 0 descendants of its own.
- 5 other devices also cite its predicate K934070.
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 Accu-Chek A;.™ Hemoglobin Test is designed for use with BMC Hitachi reagents that
measure glycosylated hemoglobin. The test has not been evaluated using any other
methodology. The device is intended for at-home or in-office use to collect a whole blood
sample. The product will be marketed over-the-counter. Test results should be evaluated
together with a personal doctor.
Measurement of glycosylated hemoglobin is used to assess the level of control of a patient’s
diabetes and to determine the proper insulin dosage for a patient. Elevated levels of
glycosylated hemoglobin indicate uncontrolled diabetes in a patient. 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/K974491 · printed Nov 4, 2026
Cite this page
510(k) Report. “K974491: Accu-Chek A1C Hemoglobin Test.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K974491
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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