IMMULITE/IMMULITE 1000 TOTAL TESTOSTERONE AND IMMULITE 2000 TOTAL TESTOSTERONE

K032881 · Diagnostic Products Corp. · CDZ · Oct 10, 2003 · Clinical Chemistry

Device Facts

• Record ID: K032881
• Device Name: IMMULITE/IMMULITE 1000 TOTAL TESTOSTERONE AND IMMULITE 2000 TOTAL TESTOSTERONE
• Applicant: Diagnostic Products Corp.
• Product Code: CDZ · Clinical Chemistry
• Decision Date: Oct 10, 2003
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1680
• Device Class: Class 1

Indications for Use

IMMULITE/IMMULITE 1000 Total Testosterone: For in vitro diagnostic use with the IMMULITE and IMMULITE 1000 Analyzers - for the quantitative measurement of testosterone in serum and plasma, as an aid in the diagnosis and management of conditions involving excess or deficiency of this androgen. IMMULITE 2000 Total Testosterone: For in vitro diagnostic use with the IMMULITE 2000 Analyzer - for the quantitative measurement of total testosterone in serum and plasma, as an aid in the diagnosis and management of conditions involving excess or deficiency of this androgen.

Device Story

Solid-phase, competitive chemiluminescent immunoassay; used with IMMULITE, IMMULITE 1000, or IMMULITE 2000 analyzers. Input: patient serum or plasma sample. Process: sample and alkaline phosphatase-labeled testosterone compete for binding sites on rabbit antibody-coated polystyrene beads; incubation at 37°C; centrifugal wash removes unbound material; substrate (phosphate ester of adamantyl dioxetane) added; hydrolysis by alkaline phosphatase produces light. Output: photon emission measured by luminometer; light intensity inversely proportional to testosterone concentration. Used in clinical laboratories; operated by laboratory technicians. Results assist clinicians in diagnosing/managing androgen-related disorders.

Clinical Evidence

No clinical data provided; substantial equivalence is based on bench testing and performance characteristics of the immunoassay system.

Technological Characteristics

Solid-phase, competitive chemiluminescent immunoassay. Components: polystyrene bead coated with polyclonal rabbit anti-testosterone antibody. Energy source: luminometer for photon detection. Reagents: alkaline phosphatase-labeled testosterone, phosphate ester of adamantyl dioxetane substrate. Incubation: 37°C with intermittent agitation. Connectivity: integrated with IMMULITE/IMMULITE 1000/2000 analyzer systems.

Indications for Use

Indicated for quantitative measurement of total testosterone in serum and plasma to aid in diagnosis and management of conditions involving androgen excess or deficiency, including hypogonadism, puberty disorders, impotence, hirsutism, and virilization.

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.

Submission Summary (Full Text)

{0}

SPECIAL 510(k): Device Modification ODE Review Memorandum

To: THE FILE

RE: DOCUMENT NUMBER K032881

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.)
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.
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 a change in antibody supplier and minor manufacturing changes.

4. Comparison Information (similarities and differences) to applicant's legally marketed predicate device including, labeling, intended use, physical characteristics

Predicate Device calibration range: 50 -1600 ng/dL

New Device calibration range: 20 -1600 ng/dL

This change was reflected in labeling.

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
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.