510(k) · Cleared
ClearedHemoglobin Capillary Collection System (HCCS), 1 Test, Hemoglobin Capillary Collection System (HCCS), 5 Tests, Hemoglobi
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bio-Rad Laboratories, Inc. · JKA Tubes, Vials, Systems, Serum Separators, Blood Collection
Cleared on Jun 3, 2009 as substantially equivalent to K070452 (Bio-Rad Laboratories, Inc., 2007) and 1 other predicate after a 75-day review. Its family tree reaches back 3 generations to 1993.
- Decided
- Jun 3, 2009
- Review
- 75 days
- Class
- Class II
- Product code
- JKA
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K926469 (1993). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK926469 Variant (TM) Hemoglobin a 1C ProgramBio-Rad · 1993
- 2 generations backK984268 Variant II Hemoglobin A1C ProgramBio-Rad · 1998 · Recalled
- 1 generation backK031043 D-10 Hemoglobin A1CBio-Rad Laboratories, Inc. · 2003 · Recalled
- This deviceK090737 Hemoglobin Capillary Collection System (HCCS), 1 Test, Hemoglobin…Bio-Rad Laboratories, Inc. · 2009
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K926469 | Variant (TM) Hemoglobin a 1C Program | Bio-Rad | 1993 | — |
| −2 | K984268 | Variant II Hemoglobin A1C Program | Bio-Rad | 1998 | 2 |
| −1 | K031043 | D-10 Hemoglobin A1C | Bio-Rad Laboratories, Inc. | 2003 | 6 |
| 0 (this device) | K090737 | Hemoglobin Capillary Collection System (HCCS), 1 Test, Hemoglobin Capillary… | Bio-Rad Laboratories, Inc. | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 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 JKA? 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 JKA device
- #1 K200027 Blood Collection Needle with/without Holder…score 15.6 · 3 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 |
|---|---|---|---|
| * | K070452 | Variant II Hemoglobin A1C Program with Models 270-2101NUSummary page 1…n Name: Blood specimen collection device, JKA Assay, Glycosylated hemoglobin, LCP Predicate Devices: VARIANTTM II Hemoglobin Alc Program, Bio-Rad Laboratories, Inc., K070452 - Wash/Diluent Solution D-10TM Hemoglobin Aic Program, Bio-Rad Laboratories, Inc., K03 1043 - Wash/Diluent Solution Intended Us… | 2007 |
| * | K031043 | D-10 Hemoglobin A1CSummary page 1…te Devices: VARIANTTM II Hemoglobin Alc Program, Bio-Rad Laboratories, Inc., K070452 - Wash/Diluent Solution D-10TM Hemoglobin Aic Program, Bio-Rad Laboratories, Inc., K03 1043 - Wash/Diluent Solution Intended Use: The Hemoglobin Capillary Collection System (HCCS) is intended for the collection of human… | 2003 |
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 16 years and passes through 2 companies; a new generation was cleared every 5.7 years on median.
- 3 of the 4 ancestors have a recall of any class.
- 4 other devices also cite its predicate K070452.
How does its category compare?
All JKA devicesJKA Tubes, Vials, Systems, Serum Separators, Blood Collection: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · JKA
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JKA
115in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JKA
13in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JKA
6,089in 2025
MAUDE reports naming product code JKA, 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 | 4 | 281 | 3 | 73 |
| 2008 | 2 | — | 3 | 78 |
| 2009 | 2 | — | 3 | 42 |
| 2010 | 4 | 28 | 4 | 37 |
| 2011 | 0 | — | 14 | 67 |
| 2012 | 1 | — | 2 | 54 |
| 2013 | 3 | 244 | 1 | 33 |
| 2014 | 1 | — | 1 | 68 |
| 2015 | 1 | — | 6 | 41 |
| 2016 | 4 | 116 | 1 | 65 |
| 2017 | 2 | — | 2 | 2,039 |
| 2018 | 1 | — | 2 | 9,731 |
| 2019 | 6 | 181 | 9 | 6,469 |
| 2020 | 6 | 181 | 0 | 3,774 |
| 2021 | 4 | 217 | 3 | 3,610 |
| 2022 | 9 | 164 | 2 | 3,375 |
| 2023 | 17 | 189 | 2 | 4,400 |
| 2024 | 6 | 240 | 0 | 4,609 |
| 2025 | 7 | 115 | 13 | 6,089 |
| 2026 | 8 | 250 | 1 | — |
What is it indicated for?
The Hemoglobin Capillary Collection System (HCCS) is intended for the collection of human whole blood for the percent determination of hemoglobin A1c using Bio-Rad HPLC methods.
For in vitro diagnostic use.
The measurement of percent hemoglobin A1c is effective in monitoring long-term glucose control in individuals with diabetes mellitus.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090737 · printed Nov 6, 2026
Cite this page
510(k) Report. “K090737: Hemoglobin Capillary Collection System (HCCS), 1 Test, Hemoglobin Capillary Collection System (HCCS), 5 Tests, Hemoglobi.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090737
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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