ARCHITECT B12

K121314 · Abbott Laboratories · CDD · May 17, 2012 · Clinical Chemistry

Device Facts

• Record ID: K121314
• Device Name: ARCHITECT B12
• Applicant: Abbott Laboratories
• Product Code: CDD · Clinical Chemistry
• Decision Date: May 17, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1810
• Device Class: Class 2

Indications for Use

The ARCHITECT B12 assay is a chemiluminescent microparticle Intrinsic Factor assay for the quantitative determination of vitamin B12 in human serum and plasma on the ARCHITECT i System. Measurements obtained by this device are used in the diagnosis and treatment of anemias of gastrointestinal malabsorption. The ARCHITECT B12 Calibrators are used to calibrate the ARCHITECT i System when the system is used for the quantitative determination of vitamin B12 in human serum and plasma using the ARCHITECT B12 Reagent Kit. The ARCHITECT B12 Controls are used for the estimation of test precision and the detection of systematic analytical deviations of the ARCHITECT i System when used for the quantitative determination of vitamin B12 in human serum and plasma when using the ARCHITECT B12 Reagent Kit.

Device Story

The ARCHITECT B12 assay is a two-step chemiluminescent microparticle immunoassay (CMIA) performed on the ARCHITECT i System. It uses intrinsic factor-coated microparticles to capture vitamin B12 from human serum or plasma samples. The process includes automated sample pretreatment using sodium hydroxide, potassium cyanide, alpha monothioglycerol, and cobinamide dicyanide to release B12 from binding proteins. An acridinium-labeled conjugate is used for detection. The system is operated by laboratory professionals in a clinical setting. The output is a quantitative concentration of vitamin B12 (pg/mL), which clinicians use to diagnose and monitor anemias related to gastrointestinal malabsorption.

Clinical Evidence

Bench testing only. A 20-day precision study (CLSI EP5-A2) on lithium heparin plasma panels demonstrated total imprecision of ≤ 10% CV. A tube type comparison study (CLSI EP7-A2) with 63 donors compared lithium heparin plasma separator tubes to plastic serum tubes; the median difference was 3.3% (95% CI: 2.2%, 4.7%), falling within the 10% allowable difference criteria. Passing-Bablok regression showed high correlation (r ≥ 0.997) between tube types.

Technological Characteristics

CMIA technology; automated two-step assay. Reagents include intrinsic factor (porcine) coated microparticles, acridinium-labeled conjugate, and pre-treatment reagents (NaOH, KCN, alpha monothioglycerol, cobinamide dicyanide). Platform: ARCHITECT i System. Calibration range: 0-2,000 pg/mL. Measuring interval: 146-2,000 pg/mL. Connectivity: Integrated with ARCHITECT i System. Software: Embedded firmware for instrument control and data processing.

Indications for Use

Indicated for the quantitative determination of vitamin B12 in human serum and plasma to aid in the diagnosis and treatment of anemias of gastrointestinal malabsorption.

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.

Submission Summary (Full Text)

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# Decision Summary

Statement for the Record, k121314

This 510(k) was reviewed under OIVD’s Pilot Triage Program. This program represents an internal workload management tool intended to reduce internal FDA review resources for 510(k) applications that are of good quality upon receipt by FDA.

The information in the 510(k) is complete and supports a substantial equivalence (SE) determination. Please refer to the applicant’s 510(k) summary for a summary of the information that supports this SE determination.

OIVD, 4/2/12, v1.1