BAYER SPECIAL CHEMISTRY CONTROLS

K033379 · Bayer Diagnostics Corp. · JJY · Dec 19, 2003 · Clinical Chemistry

Device Facts

• Record ID: K033379
• Device Name: BAYER SPECIAL CHEMISTRY CONTROLS
• Applicant: Bayer Diagnostics Corp.
• Product Code: JJY · Clinical Chemistry
• Decision Date: Dec 19, 2003
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Indications for Use

The Special Chemistry Controls are assayed control materials for in vitro diagnostic use to monitor the precision and accuracy of certain chemistry test procedures for the ADVIA Chemistry analyzers.

Device Story

Bayer Special Chemistry Controls are lyophilized quality control materials derived from human serum with added non-serum constituents. They are used to monitor the precision and accuracy of chemistry test procedures on ADVIA Chemistry analyzers. The controls require reconstitution with 5.0 mL of distilled water before use. They are intended for clinical laboratory use by trained personnel to ensure the performance of diagnostic assays. The device provides a reference point for quality control, allowing healthcare providers to verify that chemistry analyzers are functioning correctly, thereby ensuring the reliability of patient test results.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Lyophilized human serum-based control material; requires reconstitution with 5.0 mL distilled water. Analyte list includes Acid Phosphatase, Lactate, Pancreatic Amylase, Lipase, Cholinesterase, and Direct TIBC. Designed for use on ADVIA Chemistry analyzers.

Indications for Use

Indicated for in vitro diagnostic use to monitor the precision and accuracy of chemistry test procedures on ADVIA Chemistry systems.

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

• Bayer Special Chemistry Control (k030801)

Submission Summary (Full Text)

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510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION
DECISION SUMMARY
DEVICE TEMPLATE

A. 510(k) Number: k033379
B. Analyte: Special Chemistry Control – Acid Phosphatase, Lactate, Lipase, Pancreatic Lipase, Cholinesterase, and Direct TIBC
C. Type of Test: N/A
D. Applicant: Bayer Healthcare
E. Proprietary and Established Names: Bayer ADVIA 1650 Special Chemistry Control
F. Regulatory Information:
1. Regulation section: 21 CFR 862.1660
2. Classification: Class I
3. Product Code: JJY
4. Panel: 75
G. Intended Use:
1. Indication(s) for use: For in vitro diagnostic use in the control of ADVIA Chemistry systems for certain chemistry methods.
2. Special condition for use statement(s): none
3. Special instrument Requirements: Bayer ADVIA Systems
H. Device Description: The Bayer Special Chemistry Controls are two separate levels of quality control material prepared from human serum with non-serum constituents added.
I. Substantial Equivalence Information:
1. Predicate device name(s): Bayer Special Chemistry Control
2. Predicate K number(s): k030801

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3. Comparison with predicate:

| DEVICE | PREDICATE |
| --- | --- |
| A. Similarities | |
| Analyte Constituents
Acid Phosphatase, Lactate, Lipase, Pancreatic Amylase, Cholinesterase, and Direct TIBC* | Analyte Constituents
Acid Phosphatase, Lactate, Lipase, Pancreatic Amylase, Cholinesterase, and Direct TIBC with newly assayed values for Direct TIBC |
| Performance of above analytes
Meets medical decision levels | Performance of above analytes
Meets medical decision levels |
| Source material
Human Serum | Source material
Human Serum |
| Storage and Handling
Unreconstituted 2-8°C
Reconstituted 2-8°C, 7 days | Storage and Handling
Unreconstituted 2-8°C
Reconstituted 2-8°C, 7 days |
| Instructions for use
Use the control material according to directions accompanying the instrument or assay prior to use. Treat the control material in the same manner as patient samples. | Instructions for use
Use the control material according to directions accompanying the instrument or assay prior to use. Treat the control material in the same manner as patient samples. |
| Limitations
The results obtained depend on several factors: erroneous results can occur from improper storage, reconstitution errors, inadequate mixing, or sampling handling errors. Do not use if there is visible evidence of microbial growth in the vial. | Limitations
The results obtained depend on several factors: erroneous results can occur from improper storage, reconstitution errors, inadequate mixing, or sampling handling errors. Do not use if there is visible evidence of microbial growth in the vial. |

* 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 – Points to Consider Guidance Document on Assayed and Unassayed Quality Control Material

K. Test Principle: N/A

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# 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): stored master lot
d. Detection limit (functional sensitivity): N/A
e. Analytical specificity: N/A
f. Assay cut-off: N/A

2. Comparison studies:
a. Method comparison with predicate device: Control Material is identical to predicate device with the exception of assayed values for Direct TIBC.
b. Matrix comparison: Control Material is identical to predicate device with the exception of assayed values for Direct TIBC

3. Clinical studies:
a. Clinical sensitivity: N/A
b. Clinical specificity: N/A

4. Clinical cut-off: N/A

5. Expected values/Reference range: The value assignment of the test lot is based upon the ratio of the stored master lot’s observed mean to the original assigned mean.

M. Conclusion: Based upon the information provided, I recommend that the Bayer Special Chemistry Control for the ADVIA Chemistry systems be found substantially equivalent with the predicate devices as defined in 21 CFR 862.1660.