510(k) · Cleared
Recalled · Class II · 2014Dimensions HB1C Kit, Model DF105A
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Healthcare Diagnostics · LCP Assay, Glycosylated Hemoglobin
Cleared on May 13, 2011 as substantially equivalent to K070452 (Bio-Rad Laboratories, Inc., 2007) after a 259-day review. Its family tree reaches back 3 generations to 1993. It has been recalled once.
- Decided
- May 13, 2011
- Review
- 259 days
- Class
- Class II
- Product code
- LCP
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 3 generations to K926469 (1993). 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 backK070452 Variant II Hemoglobin A1C Program with Models 270-2101NUBio-Rad Laboratories, Inc. · 2007 · Recalled
- This deviceK102510 Dimensions HB1C Kit, Model DF105ASiemens Healthcare Diagnostics · 2011
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 | K070452 | Variant II Hemoglobin A1C Program with Models 270-2101NU | Bio-Rad Laboratories, Inc. | 2007 | 1 |
| 0 (this device) | K102510 | Dimensions HB1C Kit, Model DF105A | Siemens Healthcare Diagnostics | 2011 | — |
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? (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 |
|---|---|---|---|
| * | K070452 | Variant II Hemoglobin A1C Program with Models 270-2101NUSummary page 1…Product Code: LCP/KRZ Panel: Hematology 3. Identification of the Legally Marketed Device: R10-RAD Variant®l 11Hemoglobin A,, - K070452 4. Device Descriptions: The Dimension® HB1C kit contains Flex® reagent cartridges and calibrator. Each cart… | 2007 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 30, 2014 | Class II | Z-0420-2015 | Nonconforming Material/Component | Certain lots of the reagent cartridges show confirmed positive bias averaging 0.4% Hemoglobin A1c units and occasionally up to 1.0% HbA1c units for patient samples when compared to the National Glycohemoglobin Standardization Program… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 18 years and passes through 3 companies; a new generation was cleared every 5.7 years on median.
- 2 of the 3 ancestors have a recall of any class.
- 4 other devices also cite its predicate K070452.
How does its category compare?
All LCP devicesLCP Assay, Glycosylated Hemoglobin: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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 Hb1C assay on the Dimension® clinical chemistry system is an in vitro diagnostic assay for the quantitative determination of hemoglobin A1c (HbA1c) in human anticoagulated whole blood. Measurements of hemoglobin A1c are effective in monitoring long term glucose control in individuals with diabetes mellitus.
The HbC CAL is an in vitro diagnostic product for the calibration of the Hemoglobin A1c (Hb1C) method on the Dimension® clinical chemistry system.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K102510 · printed Nov 6, 2026
Cite this page
510(k) Report. “K102510: Dimensions HB1C Kit, Model DF105A.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102510
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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