510(k) · Cleared
ClearedDiazyme Fibrinogen Assay, Diazyme Fibrinogen Calibrator Set, Diazyme Fibrinogen Control Set
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Diazyme Laboratories · GIS Test, Fibrinogen
Cleared on Jan 31, 2016 as substantially equivalent to K993482 (Kamiya Biomedical Co., 1999) after a 422-day review. Its family tree reaches back 1 generation to 1999.
- Decided
- Jan 31, 2016
- Review
- 422 days
- Class
- Class II
- Product code
- GIS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K993482 (1999). No later device cites it as a predicate yet.
- Root · 1 generation backK993482 K-Assay FibrinogenKamiya Biomedical Co. · 1999
- This deviceK143470 Diazyme Fibrinogen Assay, Diazyme Fibrinogen Calibrator Set, Diazyme…Diazyme Laboratories · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K993482 | K-Assay Fibrinogen | Kamiya Biomedical Co. | 1999 | — |
| 0 (this device) | K143470 | Diazyme Fibrinogen Assay, Diazyme Fibrinogen Calibrator Set, Diazyme… | Diazyme Laboratories | 2016 | — |
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 GIS? 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 |
|---|---|---|---|
| * | K993482 | K-Assay FibrinogenSummary page 5…21CFR 864.7340 Fibrinogen determination system Device Class Class II Predicate Device: Kamiya K-Assay Fibrinogen (k993482) Manufacturing Address Diazyme Laboratories 1… | 1999 |
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?
- Its one ancestor has no recall.
How does its category compare?
All GIS devicesGIS Test, Fibrinogen: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · GIS
1in 2016
2026 to Oct 25, outlined.
Median 510(k) review, days · GIS
Too few GIS 510(k)s in any year since 2007 to give a median.
Recalls per year · GIS
No recall names GIS since 2007.
Adverse event reports per year · GIS
8in 2007
MAUDE reports naming product code GIS, 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 | 0 | — | 0 | 8 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Diazyme Fibrinogen Assay is for the quantitative determination of fibrinogen levels in citrated human plasma. For in vitro diagnostic use only.
The Diazyme Fibrinogen Calibrator Set is intended for use in the calibration of the Diazyme Fibrinogen Assay. For in vitro diagnostic use only.
The Diazyme Fibrinogen Control Set is intended for use as quality controls for the Diazyme Fibrinogen Assay. For in vitro diagnostic use only.
The performance of this device has not been established in neonate and pediatric patient populations.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K143470 · printed Nov 6, 2026
Cite this page
510(k) Report. “K143470: Diazyme Fibrinogen Assay, Diazyme Fibrinogen Calibrator Set, Diazyme Fibrinogen 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/K143470
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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