TOX AMMONIA CALIBRATOR

K031683 · Bayer Healthcare, LLC · JIX · Aug 6, 2003 · Clinical Chemistry

Device Facts

• Record ID: K031683
• Device Name: TOX AMMONIA CALIBRATOR
• Applicant: Bayer Healthcare, LLC
• Product Code: JIX · Clinical Chemistry
• Decision Date: Aug 6, 2003
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 862.1150
• Device Class: Class 2

Indications for Use

Bayer ToxAmmonia calibrator is intended for in vitro diagnostic use to calibrate acetaminophen, ammonia, ethanol and salicylate assays on the ADVIA IMS Chemistry systems.

Device Story

ToxAmmonia Calibrator is a lyophilized mixture of human serum base with added nonhuman constituents; designed for use with ADVIA IMS Chemistry systems. Device serves as a calibration tool for clinical chemistry assays (acetaminophen, ammonia, ethanol, salicylate). Used in clinical laboratory settings by trained personnel. Provides specific analyte concentrations to calibrate system performance; ensures accuracy of patient sample testing. Reconstituted product stable for three days at 2-8°C.

Clinical Evidence

Bench testing only. Stability of calibrator values validated across three separate lots according to Bayer procedures.

Technological Characteristics

Lyophilized human serum base with nonhuman constituents. Reconstituted form stable for 3 days at 2-8°C. Designed for use with ADVIA IMS Chemistry systems. Traceability to reference materials.

Indications for Use

Indicated for in vitro diagnostic calibration of acetaminophen, ammonia, ethanol, and salicylate assays on ADVIA IMS Chemistry systems.

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

• SetPoint Chemistry Calibrator (K030169)

Submission Summary (Full Text)

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510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION
DECISION SUMMARY
DEVICE TEMPLATE

A. 510(k) Number: K031683
B. Analyte: Calibrator for multiple analytes (Ethanol, Acetaminophen, Salycilate and Ammonia)
C. Type of Test: N/A
D. Applicant: Bayer Healthcare
E. Proprietary and Established Names: Bayer Toxammonia 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: Bayer ToxAmmonia calibrator is intended for in vitro diagnostic use to calibrate acetaminophen, ammonia, ethanol and salicylate assays on the ADVIA IMS Chemistry systems.
2. Special condition for use statement(s): none
3. Special instrument Requirements: none

H. Device Description: ToxAmmonia Calibrator for the Bayer ADVIA IMS Chemistry systems. These calibrators are a lyophilized mixture of human serum base to which appropriate nonhuman constituents have been added to achieve specific concentrations is intended for in vitro diagnostic use to calibrate acetaminophen, ammonia, ethanol and salicylate assays on the ADVIA IMS Chemistry systems.

I. Substantial Equivalence Information:
1. Predicate device name(s): Bayer SetPoint Chemistry calibrator
2. Predicate K number(s): K030169

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3. Comparison with predicate:

| DEVICE | PREDICATE |
| --- | --- |
| A. Similarities | |
| Stable at 2-8° until expiration on label | Stable at 2-8° until expiration on label |
| Single levels | Single levels |
| B. Differences | |
| Liquid human serum albumin base to which appropriate nonhuman 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 Toxammonia is intended for in vitro diagnostic use to calibrate acetaminophen, ammonia, ethanol and salicylate assays on the ADVIA IMS chemistry systems | For use as a calibrator of clinical chemistry assays for automated analytical procedures |
| Stable for three days when reconstituted according to directions and stored at 2-8°C | Stable for 48 hours when reconstituted according to directions and stored at 2-8°C and protected from light with the exception of Total and direct bilirubin, which are stable for eight hours. |

J. Standard/Guidance Document Referenced (if applicable) Guidance for Industry - Abbreviated 510(k) Submissions for InVitro Diagnostic 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 SSV (System Specific Value) values for the IMS were derived from studies using reference materials. Highly purified analyte was used to prepare standards, which in turn, were used to calibrate an IMS system. This system was then used to establish the SSV for the first Master Lot of product in the nested study.
d. Detection limit (functional sensitivity): N/A
e. Analytical specificity: N/A
f. Assay cut-off: N/A

2. Comparison studies:

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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 ToxAmmonia Calibrators for the ADVIA IMS Chemistry systems be found substantially equivalent with the predicate devices as defined in 21 CFR 862.1150.