510(k) · Cleared
Recalled · Class III · 2019Architect HBA1C, Architect HBA1C, and Architect HBA1C
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Axis-Shield Diagnostics, Ltd. · LCP Assay, Glycosylated Hemoglobin
Cleared on Dec 12, 2012 as substantially equivalent to K072686 (Axis-Shield Diagnostics, Ltd., 2008) after a 170-day review. Its family tree reaches back 3 generations to 1997. It has been recalled once.
- Decided
- Dec 12, 2012
- Review
- 170 days
- Class
- Class II
- Product code
- LCP
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 3 generations to K972265 (1997). No later device cites it as a predicate yet.
- Root · 3 generations backK972265 A1C 2.2 Plus - Automated Glycohemoglobin AnalyzerTosoh Medics, Inc. · 1997
- 2 generations backK011434 G7 Automated HPLC AnalyzerTosoh Medics, Inc. · 2001 · Recalled
- 1 generation backK072686 Axsym HBA1C Reagents, Axsym HBA1C Calibrators, Axsym HBA1C ControlsAxis-Shield Diagnostics, Ltd. · 2008
- This deviceK121842 Architect HBA1C, Architect HBA1C, and Architect HBA1CAxis-Shield Diagnostics, Ltd. · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K972265 | A1C 2.2 Plus - Automated Glycohemoglobin Analyzer | Tosoh Medics, Inc. | 1997 | — |
| −2 | K011434 | G7 Automated HPLC Analyzer | Tosoh Medics, Inc. | 2001 | 2 |
| −1 | K072686 | Axsym HBA1C Reagents, Axsym HBA1C Calibrators, Axsym HBA1C Controls | Axis-Shield Diagnostics, Ltd. | 2008 | — |
| 0 (this device) | K121842 | Architect HBA1C, Architect HBA1C, and Architect HBA1C | Axis-Shield Diagnostics, Ltd. | 2012 | — |
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 |
|---|---|---|---|
| * | K072686 | Axsym HBA1C Reagents, Axsym HBA1C Calibrators, Axsym HBA1C ControlsSummary page 1…n Panel: Clinical Chemistry Product Code: JIT Legally marketed device to which equivalency is claimed: AxSYM HbAlc Reagent and AxSYM HbAlc Standard Calibrators (A-F) (k072686) Architect H-bAic 1 of 3 510(k) Premarket notification submission ADM… | 2008 |
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 |
|---|---|---|---|---|
| Apr 9, 2019 | Class III | Z-1356-2019 | Under Investigation by firm | Devices were delivered without the required dry ice. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 15 years and passes through 2 companies; a new generation was cleared every 4.7 years on median.
- 1 of the 3 ancestors has a recall of any class.
How does its category compare?
All LCP devicesLCP Assay, Glycosylated Hemoglobin: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
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?
Reagents:
The ARCHITECT HbAlc assay is a chemiluminescent microparticle immunoassay (CMIA) for the quantitative determination of percent hemoglobin Alc (HbAlc) in human whole blood on the ARCHITECT i System.
Percent HbAlc measurements are used for monitoring long term glycemic control in diabetic patients.
Calibrators:
The ARCHITECT HbAlc Calibrators are for the calibration of the ARCHITECT i System when used for the quantitative determination of percent haemnoglobin Alc (HbAlc) in human whole blood.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K121842 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121842: Architect HBA1C, Architect HBA1C, and Architect HBA1C.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121842
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