BAYER SPECIAL CHEMISTRY CALIBRATORS

K033380 · Bayer Diagnostics Corp. · JIX · Dec 16, 2003 · Clinical Chemistry

Device Facts

• Record ID: K033380
• Device Name: BAYER SPECIAL CHEMISTRY CALIBRATORS
• Applicant: Bayer Diagnostics Corp.
• Product Code: JIX · Clinical Chemistry
• Decision Date: Dec 16, 2003
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 862.1150
• Device Class: Class 2

Indications for Use

The Special Chemistry Calibrators are calibrators for in vitro diagnostic use to monitor the precision and accuracy of certain chemistry test procedures for the ADVIA 1650 Chemistry analvzer.

Device Story

Special Chemistry Calibrator is a lyophilized human serum-based material with added non-serum constituents; used to calibrate the ADVIA 1650 Chemistry analyzer. The device requires reconstitution with 5.0 mL distilled water. It provides absolute values for specific analytes—Acid Phosphatase, Lactate, Lipase, and Direct TIBC—to monitor the precision and accuracy of chemistry test procedures. Used in clinical laboratory settings by trained personnel. The output allows healthcare providers to ensure the accuracy of patient test results on the ADVIA 1650 system, supporting reliable clinical decision-making.

Clinical Evidence

No clinical data. Bench testing only. Traceability established via master lot comparison on the ADVIA 1650 system.

Technological Characteristics

Lyophilized mixture of human and bovine serum base with added nonhuman constituents. Stable at 2-8°C. Reconstituted stability: 7 days for Lactate, Lipase, and Direct TIBC; 2 days for Acid Phosphatase.

Indications for Use

Indicated for in vitro diagnostic use in the calibration of the ADVIA 1650 Chemistry system for certain chemistry methods.

Regulatory Classification

Identification

A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)

Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.

Predicate Devices

• Bayer Special Chemistry Calibrator (K030804)

Submission Summary (Full Text)

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510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION
DECISION SUMMARY
DEVICE TEMPLATE

A. 510(k) Number: k033380
B. Analyte: Calibrator for Acid Phosphatase, Lactate, Lipase and Direct TIBC
C. Type of Test: N/A
D. Applicant: Bayer Healthcare LLC
E. Proprietary and Established Names: Bayer ADVIA 1650 Special Chemistry Calibrator
F. Regulatory Information:
1. Regulation section: 21 CFR 862.1150
2. Classification: Class II
3. Product Code: JIX
4. Panel: 75
G. Intended Use:
1. Indication(s) for use: For in vitro diagnostic use in the calibration of the ADVIA 1650 Chemistry system for certain chemistry methods.
2. Special condition for use statement(s): none
3. Special instrument Requirements: Bayer ADVIA 1650
H. Device Description: This device is a Special Chemistry Calibrator for the Bayer ADVIA 1650 Chemistry system. These calibrators are a lyophilized mixture of human serum base to which appropriate nonhuman constituents have been added to achieve specific concentrations and is intended for in vitro diagnostic use to calibrate the ADVIA 1650 Chemistry system.
I. Substantial Equivalence Information:
1. Predicate device name(s): Bayer Special Chemistry Calibrator
2. Predicate K number(s): K030804
3. Comparison with predicate:

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| DEVICE | PREDICATE |
| --- | --- |
| A. Similarities | |
| Stable at 2-8° until expiration on label | Stable at 2-8° until expiration on label |
| Single levels | Single levels |
| Lyophilized mixture of human and bovine serum base to which appropriate human constituents have been added to achieve specific concentrations | Lyophilized mixture of human and bovine serum base to which appropriate human constituents have been added to achieve specific concentrations |
| Bayer Special Chemistry Calibrator is intended for in vitro diagnostic use to calibrate Acid Phosphatase, Lactate, Lipase and Direct TIBC* | Bayer Special Chemistry Calibrator is intended for in vitro diagnostic use to calibrate Acid Phosphatase, Lactate, and Lipase |
| Stable for seven days when reconstituted according to directions and stored at 2-8°C for Lactate, Lipase and Direct TIBC. Stable 2 days for Acid Phosphatase. | Stable for seven days when reconstituted according to directions and stored at 2-8°C for Lactate, and Lipase. Stable 2 days for Acid Phosphatase. |

* The predicate device contained Direct TIBC as an analyte so the manufacturing did not change, however Bayer did not assign values for the Direct TIBC at the time of the predicate device. This submission only includes information relevant to the value assignment of Direct TIBC.

J. Standard/Guidance Document Referenced (if applicable) Guidance for Industry - Abbreviated 510(k) Submissions for InVitro Calibrators

K. Test Principle: N/A

L. Performance Characteristics (if/when applicable):

1. Analytical performance:

a. Precision/Reproducibility: N/A
b. Linearity/assay reportable range: N/A
c. Traceability (controls, calibrators, or method): The commercial lot of calibrators are value assigned from a "master lot" (stored at -80°C) on the ADVIA 1650 system using the appropriate ADVIA 1650 reagents. Total lot analyte concentration = Ratio (master lot observed mean/Master Lot original assignment)* Test lot observed mean.
d. Detection limit (functional sensitivity): N/A
e. Analytical specificity: N/A
f. Assay cut-off: N/A

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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

4. Clinical cut-off: N/A

5. Expected values/Reference range: N/A

M. Conclusion: Based upon the information provided, I recommend that the Bayer Special Chemistry Calibrators for the ADVIA 1650 Chemistry systems be found substantially equivalent with the predicate devices as defined in 21 CFR 862.1150.