# K051321: Inview

- Pathway: 510(k) (Special)
- Applicant: Metrika, Inc.
- Decided: Jun 13, 2005 after 24 days
- Product code: LCP (Assay, Glycosylated Hemoglobin)
- Device class: 2
- Regulation: 21 CFR 864.7470
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K033847 (2003). 1 ancestor in all.
4 later devices descend from it; 1 cites 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)
- K033847: A1CNOW for Home and Professional Use, Metrika, Inc. (2003) Summary page 3.

## Most influential descendants
- K090413: A1CNOW+ (10 Test Kit, Professional Use) Model 3024, A1CNOW+(20 Test Kit, Professional Use) Model 3021, A1CNOW Self Chec (2009), 3 descendants of its own
- 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
- Aug 31, 2007 · Not classified · Z-0289-2008: Incorrect Test Results: Due to manufacturing errors regarding temperature compensation factors, the device will give erroneously high results if the test is performed below 70 degrees Fahrenheit.

## Indications for use
The InViewTM 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/K051321
Methodology: https://510kreport.com/methodology