Smart HBA1C Assay Kit, Model DZ168B-POC, Smart HBA1C Assay Control Kit, Model DZ168B-CON, Smart HBAC1C Analyzer
FDA 510(k) K092911 · Diazyme Laboratories
510(k) numberK092911
Submission
- Device name
- Smart HBA1C Assay Kit, Model DZ168B-POC, Smart HBA1C Assay Control Kit, Model DZ168B-CON, Smart HBAC1C Analyzer
- Applicant
- Diazyme Laboratories
Poway, CA, US - Received
- September 22, 2009
- Decision date
- April 26, 2010
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JJX – Single (Specified) Analyte Controls (Assayed And Unassayed)
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1660
- Specialty
- Clinical Chemistry
Other 510(k)s with product code JJX
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K170678 | Beta-CrossLaps CalCheck 5JJX · Traditional | Roche Diagnostics | 04/04/2017SE |
| K162173 | Elecsys CYFRA 21-1 CalCheck 5JJX · Traditional | Roche Diagnostics | 01/12/2017SE |
| K162514 | Multichem A1cJJX · Abbreviated | Technopath Manufacturing | 10/26/2016SE |
| K161874 | Audit MicroControls Linearity DROP LQ Blood GlucoseJJX · Traditional | Aalto Scientific, Ltd. | 08/10/2016SE |
| K161526 | LIAISON CMV IgM Serum Control SetJJX · Special | DiaSorin, Inc. | 06/30/2016SE |
| K161522 | LIAISON EBV IgM Serum Control SetJJX · Special | DiaSorin, Inc. | 06/30/2016SE |
| K161082 | IDS-iSYS 17-OH Progesterone Control Set, IDS-iSYS 17-OH Progesterone Calibration VerifiersJJX · Traditional | Immunodiagnostic Systems , Ltd. | 05/17/2016SE |
| K152117 | Dropper hsCRP High Sensitivity CRP ControlJJX · Traditional | Quantimetrix Corporation | 04/21/2016SE |
| K151742 | Contour Next Control SolutionJJX · Traditional | Bayer Healthcare | 09/23/2015SE |
| K143687 | ADVIA Centaur Follicle Stimulating Hormone (FSH) Master Curve Material, ADVIA Centaur…JJX · Traditional | Siemens Healthcare Diagnostics, Inc. | 07/17/2015SE |
More from Siemens Healthcare Diagnostics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K253069 | Lipoprotein (a) Molarity AssayDFC · Traditional | 06/16/2026SE |
| K252336 | Diazyme Immunoglobulin A Assay; Diazyme Immunoglobulin G Assay; Diazyme Immunoglobulin M… · Traditional | 04/24/2026SE |
| K253358 | Diazyme Human Kappa (k) Free Light Chain Assay; Diazyme Human Lambda (¿) Free Light…DFH · Traditional | 12/19/2025SE |
| K243462 | Diazyme Colorimetric Lithium AssayNDW · Traditional | 08/01/2025SE |
| K211648 | Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Chain AssayDFH · Traditional | 09/08/2022SE |
| K220001 | Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Chain AssayDFH · Traditional | 08/04/2022SE |
| K212221 | Diazyme DZ-Lite iFlash Total beta-hCG Assay, Diazyme DZ-Lite iFlash 1800…DHA · Traditional | 12/13/2021SE |
| K203136 | Diazyme PLAC® Test for Lp-PLA2 ActivityNOE · Special | 08/06/2021SE |
| K180209 | Diazyme 1,5-AG AssayNOZ · Traditional | 10/04/2018SE |
| K181438 | Diazyme Human Kappa Free Light Chain Assay; Diazyme Human Lambda Free Light Chain AssayDFH · Special | 06/26/2018SE |
Questions and answers
When was Smart HBA1C Assay Kit, Model DZ168B-POC, Smart HBA1C Assay Control Kit, Model DZ168B-CON, Smart HBAC1C Analyzer cleared by the FDA?
Smart HBA1C Assay Kit, Model DZ168B-POC, Smart HBA1C Assay Control Kit, Model DZ168B-CON, Smart HBAC1C Analyzer (K092911) received a 510(k) decision of Substantially Equivalent on April 26, 2010, 216 days after the submission was received.
What is the product code of K092911?
The FDA product code is JJX – Single (Specified) Analyte Controls (Assayed And Unassayed), a Class I (low risk) device regulated under 21 CFR 862.1660.