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

K191899 · Roche Diagnostics · CFR · Aug 16, 2019 · Clinical Chemistry

Device Facts

• Record ID: K191899
• Device Name: Glucose HK Gen.3, ISE indirect Na for Gen.2, Elecsys TSH, cobas pro integrated solutions
• Applicant: Roche Diagnostics
• Product Code: CFR · Clinical Chemistry
• Decision Date: Aug 16, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Indications for Use

The cobas pro integrated solutions is an IVD device used for the quantitation of clinical chemistry 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 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 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.

Device Story

Fully automated, random-access, software-controlled IVD system for clinical chemistry, electrolyte, and immunoassay testing. Inputs: biological fluid samples (serum, plasma, urine, CSF) in barcoded tubes. Operation: system scans barcodes; samples distributed to analytical units (c 503 for chemistry, ISE unit for sodium, e 801 for immunoassay). Glucose measured via hexokinase/G-6-PDH spectrophotometry; sodium via ion-selective electrodes (Nernst equation); TSH via sandwich ECLIA. System performs automated calibration, QC, and result calculation. Used in high-workload clinical labs by technicians. Output: quantitative analyte concentrations displayed on screen/printed. Results assist clinicians in diagnosing/treating metabolic, electrolyte, and endocrine disorders.

Clinical Evidence

Bench testing only. Precision (repeatability/intermediate) evaluated per CLSI EP05-A3 (N=84). Analytical sensitivity (LoB, LoD, LoQ) per CLSI EP17-A2. Linearity per CLSI EP06-A. Endogenous/exogenous interference and cross-reactivity tested per CLSI EP07-A2/EP37-ED1. Method comparison against predicates (N=67-138 samples) showed high correlation (r ≥ 0.997) and acceptable bias.

Technological Characteristics

System: fully automated, random-access, software-controlled. Glucose: Hexokinase/G-6-PDH photometric assay. Sodium: Ion-selective electrode (potentiometry). TSH: Sandwich ECLIA. Connectivity: Barcode-based sample ID, electronic data transfer. Software: System-specific, derived from previous Roche/Hitachi generations. Materials: Liquid, ready-to-use reagents.

Indications for Use

Indicated for quantitative determination of glucose (serum, plasma, urine, CSF), sodium (serum, plasma, urine), and thyrotropin (serum, plasma) in clinical laboratory settings for diagnosis/treatment of metabolic, electrolyte, thyroid, and pituitary disorders.

Regulatory Classification

Identification

A glucose test system is a device intended to measure glucose quantitatively in blood and other body fluids. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.

Special Controls

*Classification.* Class II (special controls). The device, when it is solely intended for use as a drink to test glucose tolerance, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.

Submission Summary (Full Text)

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# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION
## TRIAGE-QUICK REVIEW DECISION SUMMARY

510(k) Number: k191899

This 510(k) was reviewed under OIR’s Triage-Quick Review Program. This program represents an internal workload management tool intended to reduce internal FDA review resources for 510(k) applications that are of good quality upon receipt by FDA.

The information in the 510(k) is complete and supports a substantial equivalence (SE) determination. Please refer to the applicant’s 510(k) summary for a summary of the information that supports this SE determination.