Elecsys CYFRA 21-1 CalCheck 5
FDA 510(k) K162173 · Roche Diagnostics
510(k) numberK162173
Submission
- Device name
- Elecsys CYFRA 21-1 CalCheck 5
- Applicant
- Roche Diagnostics
Indianapolis, IN, US - Received
- August 3, 2016
- Decision date
- January 12, 2017
- 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
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| 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 |
| K150955 | Elecsys Progesterone III Cal Check 5JJX · Traditional | Roche Diagnostics | 05/01/2015SE |
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Questions and answers
When was Elecsys CYFRA 21-1 CalCheck 5 cleared by the FDA?
Elecsys CYFRA 21-1 CalCheck 5 (K162173) received a 510(k) decision of Substantially Equivalent on January 12, 2017, 162 days after the submission was received.
What is the product code of K162173?
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.