FASTPACK TESTO IMMUNOASSAY

K101388 · Qualigen, Inc. · CDZ · Feb 18, 2011 · Clinical Chemistry

Device Facts

• Record ID: K101388
• Device Name: FASTPACK TESTO IMMUNOASSAY
• Applicant: Qualigen, Inc.
• Product Code: CDZ · Clinical Chemistry
• Decision Date: Feb 18, 2011
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1680
• Device Class: Class 1

Indications for Use

The FastPack® Testo Immunoassay is a paramagnetic particle immunoassay for the in vitro quantitative determination of total testosterone in human serum and plasma. It is intended strictly for in-vitro diagnostic use as an aid in the diagnosis and management of conditions involving excess or deficiency of this androgen. The FastPack® Testo Immunoassay is designed for use with the FastPack® System.

Device Story

FastPack® Testo Immunoassay is a competitive chemiluminescence assay for quantitative testosterone measurement in human serum or plasma. Device utilizes disposable packs containing paramagnetic particles with covalently coupled testosterone, alkaline phosphatase-labeled monoclonal antibody, wash buffer, and ImmuGlow™ substrate. Operation occurs on FastPack® Analyzer; sample and antibody solution undergo primary incubation; reaction mixture added to paramagnetic particles for secondary incubation; unbound materials washed away; chemiluminogenic substrate added; analyzer measures resulting 'glow' at 37°C. Amount of bound labeled-antibody is inversely proportional to testosterone concentration. Used in professional clinical settings to assist physicians in diagnosing and managing androgen-related conditions. Provides quantitative results to inform clinical decision-making regarding hormone status.

Clinical Evidence

Bench testing only. Validation included method comparison, precision, linearity, limits of blank/detection/quantitation, and analytical specificity to confirm performance with lithium heparin and K2 EDTA plasma matrices compared to serum.

Technological Characteristics

Paramagnetic particle chemiluminescent immunoassay. Components: paramagnetic particles with covalently coupled testosterone, mouse monoclonal antibody labeled with alkaline phosphatase, Tris wash buffer, and ImmuGlow™ (indoxyl-3-phosphate and lucigenin) substrate. Preservatives: 0.1% sodium azide, 0.03% Proclin® 150. Operates at 37°C on FastPack® Analyzer. Professional use only.

Indications for Use

Indicated for quantitative determination of total testosterone in human serum and plasma to aid in diagnosis and treatment of androgenic hormone disorders, including hypogonadism, puberty disorders, cryptorchidism, hirsutism, virilization, and testicular or adrenal tumors.

Regulatory Classification

Identification

A testosterone test system is a device intended to measure testosterone (a male sex hormone) in serum, plasma, and urine. Measurement of testosterone are used in the diagnosis and treatment of disorders involving the male sex hormones (androgens), including primary and secondary hypogonadism, delayed or precocious puberty, impotence in males and, in females hirsutism (excessive hair) and virilization (masculinization) due to tumors, polycystic ovaries, and adrenogenital syndromes.

Predicate Devices

• FastPack® Testo Immunoassay (K021972)

Submission Summary (Full Text)

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SPECIAL 510(k): Device Modification

OIVD Review Memorandum (Decision Making Document is Attached)

To: THE FILE RE: DOCUMENT NUMBER k10388, Qualigen FastPack® Testo Immunoassay

This 510(k) submission contains information/data on modifications made to the SUBMITTER'S own Class II, Class III or Class I devices requiring 510(k). The following items are present and acceptable (delete/add items as necessary):

1. The name and 510(k) number of the SUBMITTER'S previously cleared device. (For a preamendments device, a statement to this effect has been provided.) k021972, FASTPACK TOTAL TESTOSTERONE IMMUNOASSAY

2. Submitter's statement that the INDICATION/INTENDED USE of the modified device as described in its labeling HAS NOT CHANGED along with the proposed labeling which includes instructions for use, package labeling, and, if available, advertisements or promotional materials (labeling changes are permitted as long as they do not affect the intended use).

3. A description of the device MODIFICATION(S), including clearly labeled diagrams, engineering drawings, photographs, user's and/or service manuals in sufficient detail to demonstrate that the FUNDAMENTAL SCIENTIFIC TECHNOLOGY of the modified device has not changed.

This change was for the addition of lithium heparin and K2 EDTA plasma as sample types for this device.

4. Comparison Information (similarities and differences) to applicant's legally marketed predicate device including, labeling, intended use, physical characteristics, and performance characteristics including precision, linearity, Limits of Blank, Detection, Quantitation, analytical specificity, and method comparison.

5. A Design Control Activities Summary which includes:

a) Identification of Risk Analysis method(s) used to assess the impact of the modification on the device and its components, and the results of the analysis by FMEA.

b) Based on the Risk Analysis, an identification of the verification and/or validation activities required, including methods or tests used and acceptance criteria to be applied

c) A declaration of conformity with design controls. The declaration of conformity should include:

i) A statement signed by the individual responsible, that, as required by the risk analysis, all verification and validation activities were performed by the designated individual(s) and the results demonstrated that the predetermined acceptance criteria were met, and

ii) A statement signed by the individual responsible, that the manufacturing facility is in conformance with design control procedure requirements as specified in 21 CFR 820.30 and the records are available for review.

6. A Truthful and Accurate Statement, a 510(k) Summary or Statement and the Indications for Use Enclosure (and Class III Summary for Class III devices).

The labeling for this modified subject device has been reviewed to verify that the indication/intended use for the device is unaffected by the modification. In addition, the submitter's description of the particular modification(s) and the comparative information between the modified and unmodified devices demonstrate that the fundamental scientific technology has not changed. The submitter has provided the design control information as specified in The New 510(k) Paradigm and on this basis, I recommend the device be determined substantially equivalent to the previously cleared (or their preamendment) device.