ST AIA-PACK HOMOCYSTEINE; ST AIA-PACK HOMOCYSTEINE CALIBRATOR SET; AIA-PACK HOMOCYSTEINE CONTROL SET

K121533 · Tosoh Bioscience, Inc. · LPS · Jun 15, 2012 · Clinical Chemistry

Device Facts

• Record ID: K121533
• Device Name: ST AIA-PACK HOMOCYSTEINE; ST AIA-PACK HOMOCYSTEINE CALIBRATOR SET; AIA-PACK HOMOCYSTEINE CONTROL SET
• Applicant: Tosoh Bioscience, Inc.
• Product Code: LPS · Clinical Chemistry
• Decision Date: Jun 15, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1377
• Device Class: Class 2

Intended Use

ST AIA-PACK Homocysteine is designed for IN VITRO DIAGNOSTIC USE ONLY for the quantitative measurement of homocysteine in human serum, heparinized plasma or EDTA plasma using a TOSOH AIA System Analyzer. Homocysteine measurements are used in the diagnosis and treatment of hyperhomocysteinemia or homocysteinuria. ST AIA-PACK Homocysteine Calibrator Set is intended for IN VITRO DIAGNOSTIC USE ONLY for the calibration of the ST AIA-PACK Homocysteine assay using a Tosoh AIA System Analyzer. The AIA-PACK Homocysteine Control Set is intended for IN VITRO DIAGNOSTIC USE ONLY for performing quality control procedures with the ST AIA-PACK Homocysteine Assay.

Device Story

Competitive enzyme immunoassay performed on Tosoh AIA System Analyzers. Input: human serum, heparinized plasma, or EDTA plasma. Process: sample pretreatment reduces oxidized homocysteine to free form using TCEP; conversion to S-adenosyl-L-homocysteine (SAH) via SAH hydrolase and adenosine; competitive binding of SAH to immobilized SAH on magnetic beads against enzyme-labeled anti-SAH monoclonal antibody; wash step; incubation with fluorogenic substrate (4MUP). Output: fluorescence rate inversely proportional to homocysteine concentration. Used in clinical laboratories by trained personnel. Results assist clinicians in diagnosing/treating hyperhomocysteinemia or homocysteinuria.

Clinical Evidence

Bench testing only. Performance validated per CLSI guidelines (EP5-A2, EP6-A2, EP17-A, EP9-A2). Precision: CVs 3.1-5.0%. Linearity: 0.5-50.0 µmol/L. Limit of detection: 0.334 µmol/L. Method comparison (n=138) vs. alternate method showed R=0.984, slope 1.079. Matrix comparison (n=98) between EDTA plasma, heparinized plasma, and serum showed high correlation (R=0.991). No clinical studies performed.

Technological Characteristics

Competitive enzyme immunoassay. Materials: magnetic beads, anti-SAH mouse monoclonal antibody, 4MUP fluorogenic substrate. Energy source: Tosoh AIA System Analyzer (automated). Connectivity: standalone analyzer. Software: automated calculation of concentrations via standard curve. Sterilization: not specified.

Indications for Use

Indicated for quantitative measurement of homocysteine in human serum, heparinized plasma, or EDTA plasma to assist in the diagnosis and treatment of hyperhomocysteinemia or homocysteinuria. No specific age or gender restrictions provided.

Regulatory Classification

Identification

A urinary homocystine (nonquantitative) test system is a device intended to identify homocystine (an analogue of the amino acid cystine) in urine. The identification of urinary homocystine is used in the diagnosis and treatment of homocystinuria (homosystine in urine), a heritable metabolic disorder which may cause mental retardation.

Submission Summary (Full Text)

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Decision Summary, k121533

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, 6/12/12, v1.2