510(k) · Cleared
ClearedDiazyme Cystatin C Poc Test Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Diazyme Laboratories · NDY Test, Cystatin C
Cleared on Mar 30, 2012 as substantially equivalent to K093680 (Diazyme Laboratories, 2010) and 1 other predicate after a 290-day review. Its family tree reaches back 2 generations to 2007.
- Decided
- Mar 30, 2012
- Review
- 290 days
- Class
- Class II
- Product code
- NDY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K070734 (2007). 3 ancestors in all. No later device cites it as a predicate yet.
- Root · 2 generations backK070734 Modification to: Direct Enzymatic HBA1C Assay Kit, Model# DZ168A…Diazyme Laboratories · 2007 · Recalled
- 1 generation backK092911 Smart HBA1C Assay Kit, Model DZ168B-Poc, Smart HBA1C Assay Control…Diazyme Laboratories · 2010
- This deviceK111664 Diazyme Cystatin C Poc Test KitDiazyme Laboratories · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K070734 | Modification to: Direct Enzymatic HBA1C Assay Kit, Model# DZ168A, DZ168A-Cal… | Diazyme Laboratories | 2007 | 1 |
| −1 | K092911 | Smart HBA1C Assay Kit, Model DZ168B-Poc, Smart HBA1C Assay Control Kit, Model… | Diazyme Laboratories | 2010 | — |
| 0 (this device) | K111664 | Diazyme Cystatin C Poc Test Kit | Diazyme Laboratories | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 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 NDY? 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 NDY device
- #1 K242585 Cystatin Cscore 10.5 · 5 generations · no Class I recall
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 |
|---|---|---|---|
| * | K093680 | Diazyme Cystatin C AssaySummary page 1…1 (Assay) Class I (Control) Predicate Device Diazyme Cystatin C Assay k093680, k092911I Establishment Registration 2032900 Pre-m… | 2010 |
| * | K092911 | Smart HBA1C Assay Kit, Model DZ168B-Poc, Smart HBA1C Assay Control Kit, Model…Summary page 1…Class I (Control) Predicate Device Diazyme Cystatin C Assay k093680, k092911I Establishment Registration 2032900 Pre-market not… | 2010 |
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 5 years and passes through 1 company; a new generation was cleared every 3.0 years on median.
- 1 of the 3 ancestors has a recall of any class.
- 1 other device also cites its predicate K093680.
How does its category compare?
All NDY devicesNDY Test, Cystatin C: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · NDY
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NDY
265in 2010
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NDY
1in 2020
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NDY
10in 2025
MAUDE reports naming product code NDY, 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 | 3 | 95 | 0 | 0 |
| 2008 | 6 | 101 | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 3 | 265 | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 1 | — | 0 | 1 |
| 2017 | 1 | — | 0 | 2 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 0 | — | 1 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 2 |
| 2024 | 0 | — | 0 | 3 |
| 2025 | 1 | — | 0 | 10 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Diazyme Cystatin C Point-of Care (POC) test reagents are intended for use with the SMART analyzer for the quantitative determination of Cystatin C in venous whole blood by latex enhanced immunoturbidimetric method. The measurement of Cystatin C is used as an aid in the diagnosis and treatment of renal disease. For in vitro Diagnostic Use Only.
The Diazyme Cystatin C POC Test Control Kit is intended for use as quality controls for the Cystatin C POC Test. For in vitro Diagnostic Use Only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K111664 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111664: Diazyme Cystatin C Poc Test Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111664
Report an extraction error
Are you the manufacturer?
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