ROCHE COMBITROL AND AUTOTROL PLUS B MULTI ANALYTE CONTROL

K032453 · Bionostics, Inc. · JJY · Aug 28, 2003 · Clinical Chemistry

Device Facts

• Record ID: K032453
• Device Name: ROCHE COMBITROL AND AUTOTROL PLUS B MULTI ANALYTE CONTROL
• Applicant: Bionostics, Inc.
• Product Code: JJY · Clinical Chemistry
• Decision Date: Aug 28, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Indications for Use

COMBITROL PLUS B / AUTOTROL PLUS B assayed controls are intended to be used to monitor and evaluate the analytical performance of the Roche OMNI S for analytes listed in the package insert. Prescription Use Only

Device Story

Device is a three-level, aqueous liquid control material; used by laboratory personnel to perform periodic quality control checks on the Roche OMNI S Analyzer. Contains clinically relevant concentrations of pH, blood gases, electrolytes, metabolites, and hematocrit; includes dyes to simulate bilirubin and hemoglobin derivatives. Non-hazardous, non-biological solution. Provides a method for laboratories to verify analytical performance; ensures accuracy of clinical measurements; supports quality assurance programs.

Clinical Evidence

No clinical data. Bench testing only; included real-time stability evaluation and precision testing.

Technological Characteristics

Buffered, aqueous electrolyte solution equilibrated with CO2 and O2 gas mixture. Three-level control system. Packaged in 1.7 mL clear glass ampoules. Designed specifically for Roche OMNI S analyzer.

Indications for Use

Indicated for use as assayed controls to monitor and evaluate the analytical performance of the Roche OMNI S analyzer for pH, blood gases, Na⁺, K⁺, Cl⁻, iCa²⁺, tHb and Hb derivatives, glucose, Urea/BUN, lactate, and bilirubin.

Regulatory Classification

Identification

A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.

Predicate Devices

• Blood Gas, Electrolyte, and CO-Oximetry Control (K913133)
• Blood Gas, Electrolyte, Metabolite Control (K972868)

Submission Summary (Full Text)

{0}

510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION
DECISION SUMMARY
DEVICE ONLY TEMPLATE

A. 510(k) Number:
K032453

B. Analytes:
Controls for the measurement of pH, blood gases, Na⁺, K⁺, Cl⁻, iCa²⁺, tHb and Hb derivatives, glucose, Urea/BUN, lactate, and bilirubin

C. Type of Test:
N/A (controls only)

D. Applicant:
Bionostics, Inc.

E. Proprietary and Established Names:
Roche COMBITROL PLUS B and Roche AUTOTROL PLUS B Multi Analyte Controls

F. Regulatory Information:
1. Regulation section:
CFR 862.1660
2. Classification:
Class I
3. Product Code:
JJY
4. Panel:
Clinical Chemistry (75)

G. Intended Use:
1. Indication(s) for use:
COMBITROL PLUS B / AUTOTROL PLUS B assayed controls are intended to be used to monitor and evaluate the analytical performance of the Roche OMNI S for analytes listed in the package insert.
2. Special condition for use statement(s):
Prescription Use Only
3. Special instrument Requirements:
Roche OMNI S

H. Device Description:
The COMBITROL PLUS B / AUTOTROL PLUS B assayed controls consist of three levels of a non-hazardous aqueous-based solution and are to be used to monitor the performance of the Roche OMNI S analyzer only. The contents of the COMBITROL PLUS B and AUTOTROL PLUS B assayed controls are identical. The AUTOTROL PLUS B control is designed to work with the optional Auto QC module, while the COMBITROL PLUS B is designed for analyzers without this option.

I. Substantial Equivalence Information:
1. Predicate device name(s):
Blood Gas, Electrolyte, and CO-Oximetry Control; Blood Gas, Electrolyte, Metabolite Control

{1}

Page 2 of 3

2. Predicate K number(s):
K913133; K972868

3. Comparison with predicate:

| Similarities | | | |
| --- | --- | --- | --- |
| Item | Device | Predicate 1 | Predicate 2 |
| Name | Roche COMBITROL PLUS B / AUTOTROL PLUS B | Blood Gas, Electrolyte, and CO-Oximetry Control | Blood Gas, Electrolyte, Metabolite Control |
| 510(k) Number | K032453 | K913133 | K972868 |
| No. of Levels | 3 | 3 | 3 |
| Analytes | pH, blood gases, Na⁺, K⁺, Cl⁻, iCa++, tHb and Hb derivatives, glucose, Urea/BUN, lactate, and bilirubin | pH, blood gases, Na⁺, K⁺, Cl⁻, iCa++, tHb and Hb derivatives | pH, blood gases, Na⁺, K⁺, Li⁺, Cl⁻, iMg++, iCa++, glucose, lactate, BUN, creatinine |
| Container | Clear, glass ampoule | Clear, glass ampoule | Clear, glass ampoule |
| Matrix | Buffered, aqueous electrolyte solution equilibrated with carbon dioxide and oxygen gas mixture | Buffered, aqueous electrolyte solution equilibrated with carbon dioxide and oxygen gas mixture | Buffered, aqueous electrolyte solution equilibrated with carbon dioxide and oxygen gas mixture |
| Differences | | | |
| Item | Device | Predicate 1 | Predicate 2 |
| Color | Red | Red | Clear |
| Fill volume | 1.7 mL | 2.5 mL | 2.5 mL |

J. Standard/Guidance Document Referenced (if applicable):
N/A

K. Test Principle:
N/A

L. Performance Characteristics (if/when applicable):
1. Analytical performance:
a. Precision/Reproducibility:
The 17 analytes contained in these controls were analyzed on a Roche OMNI S analyzer according to NCCLS Evaluation Protocol EP-05. Coefficients of variation ranged from <1 to 5.6%.
b. Linearity/assay reportable range:
N/A
c. Traceability (controls, calibrators, or method):
In - house reference lot
d. Detection limit:
N/A
e. Analytical specificity:
N/A

{2}

Page 3 of 3

f. Assay cut-off:
N/A

2. Comparison studies:
a. Method comparison with predicate device:
N/A
b. Matrix comparison:
N/A

3. Clinical studies:
a. Clinical sensitivity:
N/A
b. Clinical specificity:
N/A
c. Other clinical supportive data (when a and b are not applicable):

4. Clinical cut-off:
N/A

5. Expected values/Reference range:
N/A

M. Conclusion:
Based upon the information provided for the file, I recommend that the Roche COMBITROL PLUS B and AUTOTROL PLUS B Multi Analyte Controls are substantially equivalent to the predicate devices.