510(k) · Cleared
ClearedSmart HBA1C Assay Kit, Model DZ168B-Poc, Smart HBA1C Assay Control Kit, Model DZ168B-Con, Smart HBAC1C Analyzer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Diazyme Laboratories · JJX Single (Specified) Analyte Controls (Assayed And Unassayed)
Cleared on Apr 26, 2010 as substantially equivalent to K070734 (Diazyme Laboratories, 2007) after a 216-day review. Its family tree reaches back 1 generation to 2007. 1 later device descends from it.
- Decided
- Apr 26, 2010
- Review
- 216 days
- Class
- Class I
- Product code
- JJX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K070734 (2007). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK070734 Modification to: Direct Enzymatic HBA1C Assay Kit, Model# DZ168A…Diazyme Laboratories · 2007 · Recalled
- This deviceK092911 Smart HBA1C Assay Kit, Model DZ168B-Poc, Smart HBA1C Assay Control…Diazyme Laboratories · 2010
- Descendant · cites it directly · 0 of its ownK111664 Diazyme Cystatin C Poc Test KitDiazyme Laboratories · 2012
Most influential descendants
Showing 1 of 1 · See all- K111664Diazyme Cystatin C Poc Test KitDiazyme Laboratories · 2012 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K070734 | Modification to: Direct Enzymatic HBA1C Assay Kit, Model# DZ168A, DZ168A-Cal… | Diazyme Laboratories | 2007 | 1 |
| 0 (this device) | K092911 | Smart HBA1C Assay Kit, Model DZ168B-Poc, Smart HBA1C Assay Control Kit, Model… | Diazyme Laboratories | 2010 | — |
| +1 | K111664 | Diazyme Cystatin C Poc Test Kit | Diazyme Laboratories | 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 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 JJX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K070734 | Modification to: Direct Enzymatic HBA1C Assay Kit, Model# DZ168A, DZ168A-Cal, DZ168A-ConSummary page 2…ubstantially equivalent to the currently marketed Diazyme Direct Enzymatic HbAlc Assay (k070734). Manufacturing Address Diazyme Laboratories 12889 Gregg Court… | 2007 |
| † | K050178 | HBA1C Enzymatic Assay | 2005 |
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 |
|---|---|---|---|
| K111664 | Diazyme Cystatin C Poc Test Kit | 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?
How does its category compare?
All JJX devicesJJX Single (Specified) Analyte Controls (Assayed And Unassayed): FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · JJX
2in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · JJX
31in 2016
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JJX
1in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JJX
22in 2025
MAUDE reports naming product code JJX, 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 | 6 | 53 | 3 | 2 |
| 2008 | 8 | 52 | 3 | 0 |
| 2009 | 17 | 80 | 0 | 1 |
| 2010 | 24 | 80 | 3 | 6 |
| 2011 | 19 | 62 | 2 | 62 |
| 2012 | 15 | 40 | 0 | 32 |
| 2013 | 19 | 37 | 0 | 51 |
| 2014 | 22 | 30 | 1 | 48 |
| 2015 | 11 | 65 | 1 | 67 |
| 2016 | 6 | 31 | 2 | 37 |
| 2017 | 2 | — | 0 | 19 |
| 2018 | 0 | — | 2 | 35 |
| 2019 | 0 | — | 0 | 82 |
| 2020 | 0 | — | 0 | 77 |
| 2021 | 0 | — | 1 | 43 |
| 2022 | 0 | — | 0 | 24 |
| 2023 | 0 | — | 0 | 22 |
| 2024 | 0 | — | 0 | 30 |
| 2025 | 0 | — | 0 | 22 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
SMART Hemoglobin Alc (Glycated hemoglobin Alc; Alc; HbAlc) Assay Reagent Kit is intended for use with the SMART analyzer for the quantitative determination of stable H-bAic in human capillary and venous whole blood samples. Measurement of hemoglobin Alc is a valuable indicator for long-term diabetic control. For in vitro diagnostic use only. SMART HbAlIc Assay Controls are intended for use as quality controls for the SMART HbAlIc Assay reagents. For in…
Read the full statement (122 words)
SMART Hemoglobin Alc (Glycated hemoglobin Alc; Alc; HbAlc) Assay Reagent Kit is intended for use with the SMART analyzer for the quantitative determination of stable H-bAic in human capillary and venous whole blood samples. Measurement of hemoglobin Alc is a valuable indicator for long-term diabetic control. For in vitro diagnostic use only.
SMART HbAlIc Assay Controls are intended for use as quality controls for the SMART HbAlIc Assay reagents. For in vitro diagnostic use only.
SMART analyzer is a compact cuvette based spectrophotometei machine for point-of-care use, designed to analyze readings from single use SMART reagent cuvette. The SMART Analyzer System, consisting of the SMART Analyzer, SMART HbAlc reagent kit and SMART HbAlc Assay Controls, is for in vitro diagnostic use only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K092911 · printed Nov 5, 2026
Cite this page
510(k) Report. “K092911: Smart HBA1C Assay Kit, Model DZ168B-Poc, Smart HBA1C Assay Control Kit, Model DZ168B-Con, Smart HBAC1C Analyzer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K092911
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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