# K191899: Glucose HK Gen.3, ISE indirect Na for Gen.2, Elecsys TSH, cobas pro integrated solutions

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostics
- Decided: Aug 16, 2019 after 31 days
- Product code: CFR (Hexokinase, Glucose)
- Device class: 2
- Regulation: 21 CFR 862.1345
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K953239 (1995). 4 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060373: Cobas 6000 Series System, Roche Diagnostics (2006) Summary page 13.
- K190773: Elecsys TSH, Roche Diagnostics (2019) Summary page 15.

## Most influential descendants
- K253491: ISE indirect K for Gen.2; ISE indirect Na for Gen.2; ISE indirect Cl for Gen.2; cobas pro integrated solutions (2026), 0 descendants of its own
- K253490: Glucose HK Gen.3; ONLINE DAT Methadone II; cobas pro integrated solutions (2026), 0 descendants of its own
- K220134: cobas pure integrated solutions, Glucose HK Gen.3, ISE indirect Na for Gen.2, ONLINE DAT Methadone II, Elecsys TSH (2022), 0 descendants of its own

## Recalls of this device
- Jan 20, 2026 · Class II · Z-1476-2026: Software defect, which allows the system to accept erroneous, non-monotonous calibrations for Spline-type assays. Cobas pro integrated solutions is an automated analyzer, intended for running qualitat
- Dec 8, 2020 · Class II · Z-0755-2021: Potential for Changed Configuration Settings on the cobas 8000 modular analyzer series/cobas pro integrated solutions, may cause incorrect results in several affected parameters. In the case of poor s
- Nov 23, 2020 · Class II · Z-0752-2021: During the subsequent pipetting (1st or 2nd measurement), the residual reagent can sporadically be transferred from the conus into the reaction cuvette and lead to inaccurately low results for the aff

## Indications for use
The cobas pro integrated solutions is an IVD device used for the quantitation of clinical chemistry/ immunochemistry and Ion Selective Electrolyte parameters from various biological fluids. Glucose HK Gen.3 is an in vitro test for the quantitative determination of glucose in human serum, plasma, urine and CSF on Roche/Hitachi cobas c systems. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, idiopathic hypoglycemia and pancreatic islet cell tumors. The ISE indirect Na for Gen. 2 is intended for the quantitative determination of sodium in serum, plasma or urine using ion‑selective electrodes. Sodium measurements are used in the diagnosis and treatment of aldosteronism (excessive secretion of the hormone aldosterone), diabetes insipidus (chronic excretion of large amounts of dilute urine, accompanied by extreme thirst), adrenal hypertension, Addison's disease (caused by destruction of the adrenal glands), dehydration, inappropriate antidiuretic hormone secretion, or other diseases involving electrolyte imbalance. Elecsys TSH immunoassay is intended for the in vitro quantitative determination of thyrotropin in human serum and plasma. Measurements of TSH are used in the diagnosis of thyroid and pituitary disorders. The electrochemiluminescence immunoassay “ECLIA” is intended for use on cobas e immunoassay analyzers.

Source page: https://510kreport.com/device/K191899
Methodology: https://510kreport.com/methodology