510(k) · Cleared
ClearedNycocard HBA1C Glycosylated Hemoglobin Assay
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Primus, Inc. · LCP Assay, Glycosylated Hemoglobin
Cleared on May 22, 2000 after a 245-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 1 later device descends from it.
- Decided
- May 22, 2000
- Review
- 245 days
- Class
- Class II
- Product code
- LCP
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK993131 Nycocard HBA1C Glycosylated Hemoglobin AssayPrimus, Inc. · 2000
- Descendant · cites it directly · 0 of its ownK111128 Labonacheck A1CCeragem International, Inc. · 2012
Most influential descendants
Showing 1 of 1 · See all- K111128Labonacheck A1CCeragem International, Inc. · 2012 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K993131 | Nycocard HBA1C Glycosylated Hemoglobin Assay | Primus, Inc. | 2000 | — |
| +1 | K111128 | Labonacheck A1C | Ceragem International, Inc. | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 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? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K111128 | Labonacheck A1C | 2012 | 0 |
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, K111128 (Ceragem International, Inc., 2012) 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.
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?
Measurement of Glycohemoglobin in blood.
In vitro diagnostic use only
NycoCard HbA Ic is a laboratory test intended for the quantitative determination of percent glycated hemoglobin in whole blood using the system to monitor long term blood glucose control in individuals with diabetes mellitus.
Conditions for use:
The measurement of glycohemoglobin has not been shown to be reliable in the diagnosis of diabetes mellitus. Such use yields too many false negative and false positive results. (see Lester E. “The clinical value of glycated hemoglobin and glycated plasma proteins”. Ann Clin Biochem 19989;26:213-9)
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/K993131 · printed Nov 4, 2026
Cite this page
510(k) Report. “K993131: Nycocard HBA1C Glycosylated Hemoglobin Assay.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K993131
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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