Dropper hsCRP High Sensitivity CRP Control
FDA 510(k) K152117 · Quantimetrix Corporation
510(k) numberK152117
Submission
- Device name
- Dropper hsCRP High Sensitivity CRP Control
- Applicant
- Quantimetrix Corporation
Redondo Beach, CA, US - Received
- July 30, 2015
- Decision date
- April 21, 2016
- 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 |
| 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 |
More from Roche Diagnostics
| 510(k) | Device | Decision |
|---|---|---|
| K142262 | Aution Check PlusJJW · Traditional | 04/10/2015SE |
| K113177 | Complete D 25-OH Vitamin D ControlJJX · Traditional | 05/10/2012SE |
| K103744 | Dropper A1C Diabetes ControlJJX · Traditional | 05/12/2011SE |
| K062942 | Quantimetrix Nicosure Cotinine Urine ControlLAS · Traditional | 10/30/2006SE |
| K062751 | Modification to Quantimetrix Cardiasure Cardiac MarkerJJT · Special | 10/03/2006SE |
| K060417 | Modification to Quantimetrix Urine Drugs of Abuse ControlDIF · Special | 03/21/2006SE |
| K032791 | Glycohemosure HBA1C ControlGGM · Traditional | 10/30/2003SE |
| K030826 | Preciset Dat AmphetamineDIJ · Traditional | 04/03/2003SE |
| K021393 | Preciset Dat PlusDKB · Traditional | 06/13/2002SE |
| K013662 | Modification to Lipoprint System, LDL SubfractionsJHO · Special | 03/08/2002SE |
Questions and answers
When was Dropper hsCRP High Sensitivity CRP Control cleared by the FDA?
Dropper hsCRP High Sensitivity CRP Control (K152117) received a 510(k) decision of Substantially Equivalent on April 21, 2016, 266 days after the submission was received.
What is the product code of K152117?
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.