510(k) · Cleared
ClearedSD A1cCare System, SD A1cCare Spoit Type Test Kit, SD HbA1c Control Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sd Biosensor, Inc. · LCP Assay, Glycosylated Hemoglobin
Cleared on Sep 30, 2015 as substantially equivalent to K090413 (Bayer Healthcare, LLC, 2009) and 1 other predicate after a 547-day review. Its family tree reaches back 3 generations to 2003.
- Decided
- Sep 30, 2015
- Review
- 547 days
- Class
- Class II
- Product code
- LCP
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K033847 (2003). 6 ancestors in all, the oldest K951361 (1995). No later device cites it as a predicate yet.
- Root · 3 generations backK033847 A1CNOW for Home and Professional UseMetrika, Inc. · 2003
- 2 generations backK051321 InviewMetrika, Inc. · 2005 · Recalled
- 1 generation backK090413 A1CNOW+ (10 Test Kit, Professional Use) Model 3024, A1CNOW+(20 Test…Bayer Healthcare, LLC · 2009 · Recalled
- This deviceK140827 SD A1cCare System, SD A1cCare Spoit Type Test Kit, SD HbA1c Control…Sd Biosensor, Inc. · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K033847 | A1CNOW for Home and Professional Use | Metrika, Inc. | 2003 | — |
| −2 | K051321 | Inview | Metrika, Inc. | 2005 | 1 |
| −1 | K090413 | A1CNOW+ (10 Test Kit, Professional Use) Model 3024, A1CNOW+(20 Test Kit… | Bayer Healthcare, LLC | 2009 | 7 |
| 0 (this device) | K140827 | SD A1cCare System, SD A1cCare Spoit Type Test Kit, SD HbA1c Control Set | Sd Biosensor, Inc. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 2005 | 1 | 0 |
| 2011 | 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? (2)
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 |
|---|---|---|---|
| * | K090413 | A1CNOW+ (10 Test Kit, Professional Use) Model 3024, A1CNOW+(20 Test Kit, Professional…Summary page 4…ete photometric chemistry analyzer for clinical use Product Codes: LCP , JJE, JJX A1cNow+ (Professional Use) [k090413]; Bayer HealthCare Diabetes Care Predicate Devices: Afinion HbA1c Contols [k110056]; AXIS-SHIELD POC AS… | 2009 |
| * | K110056 | Afinion AnalyzerSummary page 4…JJE, JJX A1cNow+ (Professional Use) [k090413]; Bayer HealthCare Diabetes Care Predicate Devices: Afinion HbA1c Contols [k110056]; AXIS-SHIELD POC AS The SD A1cCare System is a reflectometry immunoassay used for the… | 2011 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 12 years and passes through 3 companies; a new generation was cleared every 3.9 years on median.
- 3 of the 6 ancestors have a recall of any class.
- 2 other devices also cite its predicate K090413.
How does its category compare?
All LCP devicesLCP Assay, Glycosylated Hemoglobin: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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 SD A1cCare System is a reflectometry immunoassay used for the quantitative measurement of glycated hemoglobin (%HbA1c) levels in fresh fingerstick capillary blood or venous whole blood samples. This system is intended for clinical laboratory and point-of-care use to monitor long term glycemic control of persons previously diagnosed with diabetes. This test is not for screening or diagnosis of diabetes. The SD A1cCare Spoit Type Test Kit is part of…
Read the full statement (170 words)
The SD A1cCare System is a reflectometry immunoassay used for the quantitative measurement of glycated hemoglobin
(%HbA1c) levels in fresh fingerstick capillary blood or venous whole blood samples. This system is intended for clinical
laboratory and point-of-care use to monitor long term glycemic control of persons previously diagnosed with diabetes.
This test is not for screening or diagnosis of diabetes.
The SD A1cCare Spoit Type Test Kit is part of the SD A1cCare System. It includes the test panel that receives the blood
sample and is used with the SD A1cCare Analyzer for the quantitative measurement of glycated hemoglobin (HbA1c)
levels in fresh fingerstick capillary or venous whole blood samples. The system is intended for clinical laboratory and
point-of-care use to monitor long term glycemic control in persons previously diagnosed with diabetes. This test is not for
screening or diagnosis of diabetes.
The SD HbA1c Control Set (Level 1, Level 2) and SD HbA1c Control Level M are intended for use as quality control
materials for the SD A1cCare System.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K140827 · printed Nov 6, 2026
Cite this page
510(k) Report. “K140827: SD A1cCare System, SD A1cCare Spoit Type Test Kit, SD HbA1c Control Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K140827
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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