510(k) · Cleared
ClearedDiazyme Carbon Dioxide Enzymatic Assay Kit, Model KZ122A
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Diazyme Laboratories · KHS Enzymatic, Carbon-Dioxide
Cleared on Jul 21, 2006 as substantially equivalent to K990754 (Diagnostic Chemicals, Ltd., 1999) after a 135-day review. Its family tree reaches back 1 generation to 1999.
- Decided
- Jul 21, 2006
- Review
- 135 days
- Class
- Class II
- Product code
- KHS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K990754 (1999). No later device cites it as a predicate yet.
- Root · 1 generation backK990754 Carbon Dioxide - L3K Assay, Catalogue Number 299-30/40/50Diagnostic Chemicals, Ltd. · 1999
- This deviceK060619 Diazyme Carbon Dioxide Enzymatic Assay Kit, Model KZ122ADiazyme Laboratories · 2006
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K990754 | Carbon Dioxide - L3K Assay, Catalogue Number 299-30/40/50 | Diagnostic Chemicals, Ltd. | 1999 | — |
| 0 (this device) | K060619 | Diazyme Carbon Dioxide Enzymatic Assay Kit, Model KZ122A | Diazyme Laboratories | 2006 | — |
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 KHS? 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 |
|---|---|---|---|
| * | K990754 | Carbon Dioxide - L3K Assay, Catalogue Number 299-30/40/50Summary page 1…iming equivalence [807.92(a)(3)]: CARBON DIOXIDE-L3K ASSAY (k990754) manufactured by Diagnostic Chemicals Limited, Oxford, CT, USA.… | 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 KHS devicesKHS Enzymatic, Carbon-Dioxide: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KHS
1in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · KHS
143in 2010
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KHS
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KHS
40in 2025
MAUDE reports naming product code KHS, 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 | 2 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 2 |
| 2009 | 1 | — | 0 | 14 |
| 2010 | 3 | 143 | 0 | 0 |
| 2011 | 1 | — | 0 | 5 |
| 2012 | 2 | — | 0 | 3 |
| 2013 | 2 | — | 1 | 2 |
| 2014 | 1 | — | 0 | 6 |
| 2015 | 0 | — | 0 | 1 |
| 2016 | 1 | — | 0 | 4 |
| 2017 | 1 | — | 0 | 7 |
| 2018 | 0 | — | 0 | 15 |
| 2019 | 0 | — | 1 | 35 |
| 2020 | 0 | — | 0 | 31 |
| 2021 | 0 | — | 0 | 14 |
| 2022 | 0 | — | 0 | 10 |
| 2023 | 0 | — | 1 | 25 |
| 2024 | 0 | — | 0 | 30 |
| 2025 | 0 | — | 1 | 40 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Diazyme Carbon Dioxide Enzymatic Assay Kit, in conjunction with Diazyme Carbon Dioxide Calibrator, are intended for the quantitative determination of carbon dioxide (CO 2) in serum and plasma. Diazyme Carbon Dioxide Enzymatic Assay Kit contains a single-point calibrator. The calibrator, along with 0.9% saline as a zero reference, is used to generate a linear graph that will be used in the calculation of carbon dioxide concentrations in unknown samples.
Diazyme Carbon Dioxide Control Set has controls for normal carbon dioxide level and abnormal carbon dioxide level. The controls are used as reference samples for checking the functionality of the Diazyme Carbon Dioxide Enzymatic Assay.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060619 · printed Nov 6, 2026
Cite this page
510(k) Report. “K060619: Diazyme Carbon Dioxide Enzymatic Assay Kit, Model KZ122A.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K060619
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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