510(k) · Cleared
ClearedA1CNOW for Home Use
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Metrika, Inc. · LCP Assay, Glycosylated Hemoglobin
Cleared on Dec 13, 2002 as substantially equivalent to K020234 (Metrika, Inc., 2002) and 1 other predicate after a 126-day review. Its family tree reaches back 1 generation to 2000.
- Decided
- Dec 13, 2002
- Review
- 126 days
- Class
- Class II
- Product code
- LCP
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K000885 (2000). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK000885 DRX HBA1C - for Prescription Home UseMetrika, Inc. · 2000
- This deviceK022661 A1CNOW for Home UseMetrika, Inc. · 2002
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K000885 | DRX HBA1C - for Prescription Home Use | Metrika, Inc. | 2000 | — |
| 0 (this device) | K022661 | A1CNOW for Home Use | Metrika, Inc. | 2002 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K020234 | A1CNOW for RX Home UseSummary page 1…a)(3): Identification of the legally marketed predicate device AlcNow™ for Home Use is substantially equivalent to A1cNow™ for Rx Home Use (K020234). The only difference between the two tests is in the intended use; A1cNow™ for Home Use will be marketed directly… | 2002 |
| * | K000885 | DRX HBA1C - for Prescription Home UseSummary page 3…AlcNow™ for Home Use AlcNow™ for Rx Home Use CHARACTERISTIC K020234, K000885 Intended Use Quantitative measurement of the Quantitative measurement of the per… | 2000 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- None of the 2 ancestors has a recall.
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 AlcNow™ test provides quantitative measurement of the percent of glycated hemoglobin
(%HbAlc) levels in capillary (fingerstick) whole blood samples. The test is for home use by
people with diabetes to monitor glycemic control.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K022661 · printed Nov 4, 2026
Cite this page
510(k) Report. “K022661: A1CNOW for Home Use.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K022661
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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