ACTIVE® Free Testosterone RIA

K191350 · Immunotech S.R.O. · CDZ · Dec 20, 2019 · Clinical Chemistry

Device Facts

• Record ID: K191350
• Device Name: ACTIVE® Free Testosterone RIA
• Applicant: Immunotech S.R.O.
• Product Code: CDZ · Clinical Chemistry
• Decision Date: Dec 20, 2019
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1680
• Device Class: Class 1
• Attributes: Pediatric

Indications for Use

The ACTIVE® Free Testosterone RIA is a radioimmunoassay for the quantitative determination of free testosterone in human serum.

Device Story

Radioimmunoassay (RIA) kit; measures free testosterone levels in human serum; utilizes polyclonal capture antibody; modification involves change in polyclonal capture antibody; fundamental scientific technology remains unchanged from predicate; intended for clinical laboratory use; provides quantitative results for diagnostic assessment of testosterone levels.

Clinical Evidence

No clinical data provided. Substantial equivalence supported by design control activities, risk analysis, and verification/validation of the modified polyclonal capture antibody.

Technological Characteristics

Radioimmunoassay (RIA) test system; utilizes polyclonal capture antibody; in vitro diagnostic reagent kit; fundamental scientific technology unchanged from predicate.

Indications for Use

Indicated for the quantitative determination of free testosterone in human serum for clinical chemistry diagnostic purposes.

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

• ACTIVE® Free Testosterone RIA (K952281)

Submission Summary (Full Text)

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FDA

U.S. FOOD & DRUG

ADMINISTRATION

# SPECIAL 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY

## I Background Information:

A 510(k) Number

K191350

B Applicant

Immunotech s.r.o.

C Proprietary and Established Names

ACTIVE® Free Testosterone RIA

D Regulatory Information

| Product Code(s) | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| CDZ | Class I, reserved | 21 CFR 862.1680 - Testosterone Test System | CH - Clinical Chemistry |

## II Review Summary:

This 510(k) submission contains information/data on modifications made to the submitter's own CLASS I device requiring 510(k). The following items are present and acceptable.

1. The name and 510(k) number of the SUBMITTER'S previously cleared device, ACTIVE® Free Testosterone RIA (k952281).
2. Submitter's statement that the INDICATIONS FOR USE/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).

Food and Drug Administration

10903 New Hampshire Avenue

Silver Spring, MD 20993-0002

www.fda.gov

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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 the polyclonal capture antibody.

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

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.

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.

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