510(k) · Cleared
Recalled · Class II · 2024A1CNOW+ (10 Test Kit, Professional Use) Model 3024, A1CNOW+(20 Test Kit, Professional Use) Model 3021, A1CNOW Self Chec
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bayer Healthcare, LLC · LCP Assay, Glycosylated Hemoglobin
Cleared on May 14, 2009 as substantially equivalent to K051321 (Metrika, Inc., 2005) after an 85-day review. Its family tree reaches back 2 generations to 2003. 3 later devices descend from it. It has been recalled 7 times.
- Decided
- May 14, 2009
- Review
- 85 days
- Class
- Class II
- Product code
- LCP
- Recalls
- 7
- Predicates
- 1
Its longest line of descent runs back 2 generations to K033847 (2003). 3 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK033847 A1CNOW for Home and Professional UseMetrika, Inc. · 2003
- 1 generation backK051321 InviewMetrika, Inc. · 2005 · Recalled
- This deviceK090413 A1CNOW+ (10 Test Kit, Professional Use) Model 3024, A1CNOW+(20 Test…Bayer Healthcare, LLC · 2009
- Descendant · cites it directly · 0 of its ownK182781 PTS Professional Chemistry KitPolymer Technology Systems, Inc. D/B/A Pts Diagnostics · 2018 · Recalled
- Descendant · cites it directly · 0 of its ownK161533 A1C EZ Glycohemoglobin Analysis SystemBiohermes Co., Ltd. · 2017
- Descendant · cites it directly · 0 of its ownK140827 SD A1cCare System, SD A1cCare Spoit Type Test Kit, SD HbA1c Control…Sd Biosensor, Inc. · 2015
Most influential descendants
Showing 3 of 3 · See all- K182781PTS Professional Chemistry KitPolymer Technology Systems, Inc. D/B/A Pts Diagnostics · 2018 · cites it directly0descendants
- K161533A1C EZ Glycohemoglobin Analysis SystemBiohermes Co., Ltd. · 2017 · cites it directly0descendants
- K140827SD A1cCare System, SD A1cCare Spoit Type Test Kit, SD HbA1c Control SetSd Biosensor, Inc. · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K033847 | A1CNOW for Home and Professional Use | Metrika, Inc. | 2003 | — |
| −1 | K051321 | Inview | Metrika, Inc. | 2005 | 1 |
| 0 (this device) | K090413 | A1CNOW+ (10 Test Kit, Professional Use) Model 3024, A1CNOW+(20 Test Kit… | Bayer Healthcare, LLC | 2009 | — |
| +1 | K182781 | PTS Professional Chemistry Kit | Polymer Technology Systems, Inc. D/B/A Pts Diagnostics | 2018 | 1 |
| +1 | K161533 | A1C EZ Glycohemoglobin Analysis System | Biohermes Co., Ltd. | 2017 | — |
| +1 | 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 |
|---|---|---|
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 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? (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 |
|---|---|---|---|
| * | K051321 | InviewSummary page 1…AI cNow® Multi-Use for Home and Professional Use Special 510(k)- Device Modification for K051321 MAY 14 2009 510(K)… | 2005 |
What descends from it? (3)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 18, 2024 | Class II | Z-0223-2025 | Under Investigation by firm | The reason for this recall is PTS Diagnostics, Inc. received complaints of non-matching cartridge and analyzer codes within the product test system box. Use of cartridges and analyzers with non-matching codes may result in inaccurate test… |
| Dec 2, 2016 | Class II | Z-0683-2020 | Software design | A numerical value less than 4% or greater than 13% may be displayed instead of the expected <4% or >13% result, due to a software bug. |
| Dec 2, 2016 | Class II | Z-0684-2020 | Software design | A numerical value less than 4% or greater than 13% may be displayed instead of the expected <4% or >13% result, due to a software bug. |
| Dec 2, 2016 | Class II | Z-0686-2020 | Software design | A numerical value less than 4% or greater than 13% may be displayed instead of the expected <4% or >13% result, due to a software bug. |
| Dec 2, 2016 | Class II | Z-0682-2020 | Software design | A numerical value less than 4% or greater than 13% may be displayed instead of the expected <4% or >13% result, due to a software bug. |
| Dec 2, 2016 | Class II | Z-0685-2020 | Software design | A numerical value less than 4% or greater than 13% may be displayed instead of the expected <4% or >13% result, due to a software bug. |
| Aug 26, 2013 | Class II | Z-0136-2014 | Nonconforming Material/Component | Test results from these lots may produce a high-bias reading (by up to 20%) that is outside of limits defined for stability and product accuracy when product is stored at room temperature four (4) to five (5) months after release. |
The 5 latest of 7 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 6 years and passes through 2 companies; a new generation was cleared every 3.9 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K182781 (Polymer Technology Systems, Inc. D/B/A Pts Diagnostics, 2018) has gone furthest, with 0 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. 2009, 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?
The A1CNow multi-use test provides quantitative measurement of the percent of glycated hemoglobin (%HbAlc, %A1C) 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 as stated in the FDA summary.
https://510kreport.com/device/K090413 · printed Nov 4, 2026
Cite this page
510(k) Report. “K090413: A1CNOW+ (10 Test Kit, Professional Use) Model 3024, A1CNOW+(20 Test Kit, Professional Use) Model 3021, A1CNOW Self Chec.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K090413
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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