510(k) · Cleared
Recalled · 2003Synchron System Hemoglobin Alc Reagent
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Beckman Instruments, Inc. · LCP Assay, Glycosylated Hemoglobin
Cleared on Nov 24, 1997 as substantially equivalent to K934070 (Boehringer Mannheim Corp., 1994) after a 59-day review. Its family tree reaches back 1 generation to 1994. It has been recalled 2 times.
- Decided
- Nov 24, 1997
- Review
- 59 days
- Class
- Class II
- Product code
- LCP
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 1 generation to K934070 (1994). No later device cites it as a predicate yet.
- Root · 1 generation backK934070 Tina-Quant Hemoglobin A1CBoehringer Mannheim Corp. · 1994
- This deviceK973696 Synchron System Hemoglobin Alc ReagentBeckman Instruments, Inc. · 1997
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K934070 | Tina-Quant Hemoglobin A1C | Boehringer Mannheim Corp. | 1994 | — |
| 0 (this device) | K973696 | Synchron System Hemoglobin Alc Reagent | Beckman Instruments, Inc. | 1997 | — |
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 |
|---|---|---|---|
| * | K934070 | Tina-Quant Hemoglobin A1CSummary page 1…in A1c (HbA1c) Reagent 3.2 Classification Name Glycosylated hemoglobin assay (21 CFR § 864.7470) 4.0 Predicate ce(s): SYNCHRON Systems Tina-quant® Boehringer Mannheim K934070 T Hemoglobin Alc Hemogiobin A1c Corporation Assay 5.0 Deseription: The SYNCHRON Hemoglobin Alc (HbA1c) Reagent kit contains two… | 1994 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 18, 2003 | Not classified | Z-1156-04 | Other | Values for ApoB were not properly assigned on the package insert. Customers were not able to recover the analyte within the stated values. |
| Aug 15, 2003 | Not classified | Z-1155-04 | Other | LDL Cholesterol component in controls are unstable. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- 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 SYNCHRON Systems Hemoglobin A1c (HbA1c) Reagent Kit, in conjunction with SYNCHRON HbA1c Calibrators and SYNCHRON HbA1c Hemolyzing Reagent, is intended for the quantitative determination of Hemoglobin Alc concentrations in whole blood on SYNCHRON Clinical Systems.
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/K973696 · printed Nov 6, 2026
Cite this page
510(k) Report. “K973696: Synchron System Hemoglobin Alc Reagent.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K973696
Report an extraction error
Are you the manufacturer?
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