510(k) · Cleared
Recalled · 2007Inview
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 Jun 13, 2005 as substantially equivalent to K033847 (Metrika, Inc., 2003) after a 24-day review. Its family tree reaches back 1 generation to 2003. 4 later devices descend from it. It has been recalled once.
- Decided
- Jun 13, 2005
- Review
- 24 days
- Class
- Class II
- Product code
- LCP
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K033847 (2003). 4 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK033847 A1CNOW for Home and Professional UseMetrika, Inc. · 2003
- This deviceK051321 InviewMetrika, Inc. · 2005
- Descendant · cites it directly · 3 of its ownK090413 A1CNOW+ (10 Test Kit, Professional Use) Model 3024, A1CNOW+(20 Test…Bayer Healthcare, LLC · 2009 · Recalled
- Descendant · 2 generations on · 0 of its ownK182781 PTS Professional Chemistry KitPolymer Technology Systems, Inc. D/B/A Pts Diagnostics · 2018 · Recalled
- Descendant · 2 generations on · 0 of its ownK161533 A1C EZ Glycohemoglobin Analysis SystemBiohermes Co., Ltd. · 2017
- Descendant · 2 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 4 of 4 · See all- K090413A1CNOW+ (10 Test Kit, Professional Use) Model 3024, A1CNOW+(20 Test Kit, Professional…Bayer Healthcare, LLC · 2009 · cites it directly3descendants
- K182781PTS Professional Chemistry KitPolymer Technology Systems, Inc. D/B/A Pts Diagnostics · 2018 · 2 generations on0descendants
- K161533A1C EZ Glycohemoglobin Analysis SystemBiohermes Co., Ltd. · 2017 · 2 generations on0descendants
- K140827SD A1cCare System, SD A1cCare Spoit Type Test Kit, SD HbA1c Control SetSd Biosensor, Inc. · 2015 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K033847 | A1CNOW for Home and Professional Use | Metrika, Inc. | 2003 | — |
| 0 (this device) | K051321 | Inview | Metrika, Inc. | 2005 | — |
| +1 | K090413 | A1CNOW+ (10 Test Kit, Professional Use) Model 3024, A1CNOW+(20 Test Kit… | Bayer Healthcare, LLC | 2009 | 7 |
| +2 | K182781 | PTS Professional Chemistry Kit | Polymer Technology Systems, Inc. D/B/A Pts Diagnostics | 2018 | 1 |
| +2 | K161533 | A1C EZ Glycohemoglobin Analysis System | Biohermes Co., Ltd. | 2017 | — |
| +2 | 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 |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K033847 | A1CNOW for Home and Professional UseSummary page 3…AlcNow® Multi-Use for Home and Professional Use (InViewTM) Special 5 10(k)- Device Modification for K033847 STATEMENT OF INTENDED USE 510(K) Number (if known): C'/ -… | 2003 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K090413 | A1CNOW+ (10 Test Kit, Professional Use) Model 3024, A1CNOW+(20 Test Kit, Professional… | 2009 | 3 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 31, 2007 | Not classified | Z-0289-2008 | Process control | 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. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- Of its descendants, K090413 (Bayer Healthcare, LLC, 2009) has gone furthest, with 3 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 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.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K051321 · printed Nov 6, 2026
Cite this page
510(k) Report. “K051321: Inview.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051321
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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