510(k) · Cleared
ClearedAccu-Base Hemoglobin A1C Sample Collection Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Diabetes Technologies, Inc. (Dti) · LCP Assay, Glycosylated Hemoglobin
Cleared on Nov 30, 1998 as substantially equivalent to K973365 (Express-Med, Inc., 1998) and 3 other predicates after an 81-day review. Its family tree reaches back 2 generations to 1986. 2 later devices descend from it.
- Decided
- Nov 30, 1998
- Review
- 81 days
- Class
- Class II
- Product code
- LCP
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 2 generations to K861697 (1986). 4 ancestors in all, the oldest K851636 (1985). 2 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 deviceK983172 Accu-Base Hemoglobin A1C Sample Collection KitDiabetes Technologies, Inc. (Dti) · 1998
- Descendant · cites it directly · 1 of its ownK993787 Appraise-Cardio Sample Collection KitOsborn Group, Inc. · 2000 · Recalled
- Descendant · 2 generations on · 0 of its ownK021698 MY Allergy TestImmunetech Corporation · 2002 · Recalled
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 |
|---|---|---|---|---|---|
| −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) | K983172 | Accu-Base Hemoglobin A1C Sample Collection Kit | Diabetes Technologies, Inc. (Dti) | 1998 | — |
| +1 | K993787 | Appraise-Cardio Sample Collection Kit | Osborn Group, Inc. | 2000 | 3 |
| +2 | K021698 | MY Allergy Test | Immunetech Corporation | 2002 | 6 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2002 | 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? (4)
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 |
|---|---|---|---|
| * | K973365 | Aic - Chek (Hbaic-I)Summary page 1…Kit. Common Name; Glycohemoglobin (HbA1c) Test Kit Classification name: Glycated Hemogiobin Assay (21 C.F.R. 864.7470 and 81LCP Predicate Device: 1. Alc-CHEK (HbA1c-1), K973365, Express Med, Inc., 2. EZCHEK™/HbAc Sample Collection Kit, FLEXSITE Diagnostics, Inc., K971919 3. Self Assure/GHb, Awareness Tech… | 1998 |
| * | K971919 | Ezchek/Hba Blood Collection KitSummary page 1…say (21 C.F.R. 864.7470 and 81LCP Predicate Device: 1. Alc-CHEK (HbA1c-1), K973365, Express Med, Inc., 2. EZCHEK™/HbAc Sample Collection Kit, FLEXSITE Diagnostics, Inc., K971919 3. Self Assure/GHb, Awareness Technology, Inc., K861697A 4, Diamat Glycosylated Hemoglobin analyzer Reagent System, Bio-Rad labo… | 1997 |
| * | K861697 | Self Assure/GHB (Capillary-Blood Collection Kit)Summary page 1…lc-CHEK (HbA1c-1), K973365, Express Med, Inc., 2. EZCHEK™/HbAc Sample Collection Kit, FLEXSITE Diagnostics, Inc., K971919 3. Self Assure/GHb, Awareness Technology, Inc., K861697A 4, Diamat Glycosylated Hemoglobin analyzer Reagent System, Bio-Rad laboratories., K851636 The Accu-Base Hemoglobin Aic Sample… | 1986 |
| * | K851636 | Diamat Glycoslated Hemoglobin Analyzer SystemSummary page 1…TE Diagnostics, Inc., K971919 3. Self Assure/GHb, Awareness Technology, Inc., K861697A 4, Diamat Glycosylated Hemoglobin analyzer Reagent System, Bio-Rad laboratories., K851636 The Accu-Base Hemoglobin Aic Sample Collection Kit is packaged in two sizes or configurations designed for professional use. One… | 1985 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K993787 | Appraise-Cardio Sample Collection Kit | 2000 | 1 |
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 4 ancestors has a recall.
- Of its descendants, K993787 (Osborn Group, Inc., 2000) has gone furthest, with 1 descendant 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.
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 intended use of the Accu-Base Hemoglobin Aic Sample Collection Kit is for the determination of the relative percent (%) hemoglobin Aic in human whole blood (capillary) samples, using high performance liquid chromatography (HPLC) as the analytical method. The Accu-Base Hemoglobin Aic Sample Collection Kit will be available to patients through Point of Care Offices and/or Centers, for the purpose of monitoring individual, long-term diabetes control as…
Read the full statement (149 words)
The intended use of the Accu-Base Hemoglobin Aic Sample Collection Kit is for the determination of the relative percent (%) hemoglobin Aic in human whole blood (capillary) samples, using high performance liquid chromatography (HPLC) as the analytical method.
The Accu-Base Hemoglobin Aic Sample Collection Kit will be available to patients through Point of Care Offices and/or Centers, for the purpose of monitoring individual, long-term diabetes control as part of a comprehensive diabetes management & treatment program.
The Accu-Base Hemoglobin Aic Sample Collection Kit does not replace daily blood glucose monitoring.
There are no known contraindications.
Keep out of reach of children.
The intended reporting path of the HbAic test results include direct reporting to the physician/health care professional responsible for the care of the individual for clinical interpretation including setting and interpreting specific HbAic target goals and test results. In addition the results may be reported to the patient.
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/K983172 · printed Nov 4, 2026
Cite this page
510(k) Report. “K983172: Accu-Base Hemoglobin A1C 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/K983172
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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