AXSYM B12

K965186 · Abbott Laboratories · CDD · Mar 24, 1997 · Clinical Chemistry

Device Facts

• Record ID: K965186
• Device Name: AXSYM B12
• Applicant: Abbott Laboratories
• Product Code: CDD · Clinical Chemistry
• Decision Date: Mar 24, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1810
• Device Class: Class 2

Intended Use

AxSYM B12 is a microparticle enzyme intrinsic factor assay for the quantitative determination of vitamin B₁₂ in human serum or plasma.

Device Story

Microparticle enzyme intrinsic factor assay; quantitative measurement of vitamin B₁₂ in human serum or plasma; performed on Abbott AxSYM System; utilizes Abbott B12 calibrators and controls for accuracy/precision verification; intended for clinical laboratory use; results aid clinicians in assessing vitamin B₁₂ levels; supports diagnosis of deficiency states.

Clinical Evidence

Bench testing only. Correlation analysis performed on 337 clinical specimens comparing AxSYM B12 to IMx B12. Results: correlation coefficient 0.975, slope 1.00, y-intercept -12.371 pg/mL, standard error of y estimate 67.281. Dynamic range 60-2,000 pg/mL.

Technological Characteristics

Microparticle enzyme intrinsic factor assay; quantitative detection; compatible with human serum and plasma (tripotassium EDTA, potassium oxalate); dynamic range 60-2,000 pg/mL; automated system-based analysis.

Indications for Use

Indicated for the quantitative determination of vitamin B₁₂ in human serum or plasma to aid in the diagnosis of vitamin B₁₂ deficiency.

Regulatory Classification

Identification

A vitamin B12 test system is a device intended to measure vitamin B12 in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of anemias of gastrointestinal malabsorption.

Predicate Devices

• Abbott IMx® B12

Submission Summary (Full Text)

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K965186

# 510(k) Summary
## Abbott AxSYM® B12

MAR 24 1997

# Summary of Safety and Effectiveness Information Supporting a Substantially Equivalent Determination

The following information as presented in the Premarket Notification for AxSYM® B12 constitutes data supporting a substantially equivalent determination.

AxSYM B12 is a microparticle enzyme intrinsic factor assay for the quantitative determination of vitamin B₁₂ in human serum or plasma. AxSYM B12 is calibrated with Abbott B12 calibrators. Abbott B12 controls are assayed for the verification of the accuracy and precision of the Abbott AxSYM System.

Substantial equivalence has been demonstrated between the Abbott AxSYM B12 assay and the Abbott IMx® B12 assay. The intended use of both assays is for the quantitative determination of vitamin B₁₂. AxSYM B12 can be performed with human serum or plasma (tripotassium EDTA and potassium oxalate). However, IMx B12 can be performed on human serum and plasma (EDTA only). A correlation analysis between these two assays, using 337 specimens, yielded a correlation coefficient of 0.975, slope of 1.00, standard error of y estimate of 67.281, and y-intercept of -12.371 pg/mL. Both assays have a dynamic range of 60 to 2,000 pg/mL.

In conclusion, these data demonstrate that Abbott AxSYM B12 is safe and effective, and is substantially equivalent to Abbott IMx B12.

Prepared and Submitted December 23, 1996 by:

Laura Granitz
(847)-938-0092
Senior Regulatory Specialist
Abbott Laboratories
200 Abbott Park Road
Abbott Park, IL 60064-3537

AxSYM B12 510(k)
December 1996
aB12510k
Attachment A
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