510(k) · Cleared
ClearedA1CNOW for Home and Professional 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 23, 2003 after a 12-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 5 later devices descend from it.
- Decided
- Dec 23, 2003
- Review
- 12 days
- Class
- Class II
- Product code
- LCP
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 1 citing it directly.
- This deviceK033847 A1CNOW for Home and Professional UseMetrika, Inc. · 2003
- Descendant · cites it directly · 4 of its ownK051321 InviewMetrika, Inc. · 2005 · Recalled
- Descendant · 2 generations on · 3 of its ownK090413 A1CNOW+ (10 Test Kit, Professional Use) Model 3024, A1CNOW+(20 Test…Bayer Healthcare, LLC · 2009 · Recalled
- Descendant · 3 generations on · 0 of its ownK182781 PTS Professional Chemistry KitPolymer Technology Systems, Inc. D/B/A Pts Diagnostics · 2018 · Recalled
- Descendant · 3 generations on · 0 of its ownK161533 A1C EZ Glycohemoglobin Analysis SystemBiohermes Co., Ltd. · 2017
- Descendant · 3 generations on · 0 of its ownK140827 SD A1cCare System, SD A1cCare Spoit Type Test Kit, SD HbA1c Control…Sd Biosensor, Inc. · 2015
Most influential descendants
Showing 5 of 5 · See all- K051321InviewMetrika, Inc. · 2005 · cites it directly4descendants
- K090413A1CNOW+ (10 Test Kit, Professional Use) Model 3024, A1CNOW+(20 Test Kit, Professional…Bayer Healthcare, LLC · 2009 · 2 generations on3descendants
- K182781PTS Professional Chemistry KitPolymer Technology Systems, Inc. D/B/A Pts Diagnostics · 2018 · 3 generations on0descendants
- K161533A1C EZ Glycohemoglobin Analysis SystemBiohermes Co., Ltd. · 2017 · 3 generations on0descendants
- K140827SD A1cCare System, SD A1cCare Spoit Type Test Kit, SD HbA1c Control SetSd Biosensor, Inc. · 2015 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K033847 | A1CNOW for Home and Professional Use | Metrika, Inc. | 2003 | — |
| +1 | K051321 | Inview | Metrika, Inc. | 2005 | 1 |
| +2 | K090413 | A1CNOW+ (10 Test Kit, Professional Use) Model 3024, A1CNOW+(20 Test Kit… | Bayer Healthcare, LLC | 2009 | 7 |
| +3 | K182781 | PTS Professional Chemistry Kit | Polymer Technology Systems, Inc. D/B/A Pts Diagnostics | 2018 | 1 |
| +3 | K161533 | A1C EZ Glycohemoglobin Analysis System | Biohermes Co., Ltd. | 2017 | — |
| +3 | K140827 | SD A1cCare System, SD A1cCare Spoit Type Test Kit, SD HbA1c Control Set | Sd Biosensor, Inc. | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2009 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K051321 | Inview | 2005 | 4 |
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?
- Of its descendants, K051321 (Metrika, Inc., 2005) has gone furthest, with 4 descendants 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 AlcNow® test provides quantitative measurement of the percent of glycated hemoglobin
(%HbA Ic, %AI1C) levels in whole blood samples. The test is for home use and professional use
for monitoring glycemic control in people with diabetes.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K033847 · printed Nov 6, 2026
Cite this page
510(k) Report. “K033847: A1CNOW for Home and Professional Use.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K033847
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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