# K090413: A1CNOW+ (10 Test Kit, Professional Use) Model 3024, A1CNOW+(20 Test Kit, Professional Use) Model 3021, A1CNOW Self Chec

- Pathway: 510(k) (Special)
- Applicant: Bayer Healthcare, LLC
- Decided: May 14, 2009 after 85 days
- Product code: LCP (Assay, Glycosylated Hemoglobin)
- Device class: 2
- Regulation: 21 CFR 864.7470
- Recalls of this device: 7 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K033847 (2003). 2 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051321: Inview, Metrika, Inc. (2005) Summary page 1.

## Most influential descendants
- K182781: PTS Professional Chemistry Kit (2018), 0 descendants of its own
- K161533: A1C EZ Glycohemoglobin Analysis System (2017), 0 descendants of its own
- K140827: SD A1cCare System, SD A1cCare Spoit Type Test Kit, SD HbA1c Control Set (2015), 0 descendants of its own

## Recalls of this device
- Sep 18, 2024 · Class II · Z-0223-2025: 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-matchi
- Dec 2, 2016 · Class II · Z-0683-2020: 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: 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: 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: 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: 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: 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 

## Indications for use
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.

Source page: https://510kreport.com/device/K090413
Methodology: https://510kreport.com/methodology