LIAISON Testosterone xt

K201908 · DiaSorin, Inc. · CDZ · Oct 15, 2020 · Clinical Chemistry

Device Facts

• Record ID: K201908
• Device Name: LIAISON Testosterone xt
• Applicant: DiaSorin, Inc.
• Product Code: CDZ · Clinical Chemistry
• Decision Date: Oct 15, 2020
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 862.1680
• Device Class: Class 1
• Attributes: Pediatric

Indications for Use

The LIAISON® Testosterone xt is an in vitro diagnostic chemiluminescence immunoassay (CLIA) for the quantitative determination of testosterone in human serum and plasma (K2EDTA, Li-heparin, Na-heparin). Measurements 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, cryptorchidism, ovarian hyperandrogenism (e.g., polycystic ovarian syndrome, hirsutism, virilization), and erectile dysfunction.

Device Story

LIAISON® Testosterone xt is an in vitro diagnostic chemiluminescence immunoassay (CLIA) for quantitative testosterone measurement in human serum/plasma; used in clinical laboratories by trained personnel. Device utilizes automated analyzer platform to process patient samples; measures testosterone levels to assist clinicians in diagnosing/managing androgen-related disorders. Modifications from predicate include extended assay measuring range (0.024–15.0 ng/mL), increased open-use stability for reagents/calibrators (8 weeks), and extended calibration curve stability (4 weeks). Output provides quantitative testosterone concentration; aids clinical decision-making regarding hormonal status and treatment efficacy.

Clinical Evidence

Bench testing only. Verification and validation activities performed to support extended measuring range, reagent/calibrator stability, and calibration curve stability. No clinical data provided.

Technological Characteristics

Direct competitive CLIA; magnetic microparticle solid phase; isoluminol-labeled conjugate. Reagents: mouse monoclonal anti-testosterone antibody, phosphate buffer, BSA, surfactant, Proclin® 300, sodium azide. Dimensions/form factor: unitized Reagent Integral for 100 tests. Energy source: LIAISON® XL Analyzer (photomultiplier detection). Connectivity: automated system. Sterilization: N/A (in vitro diagnostic reagent).

Indications for Use

Indicated for quantitative determination of testosterone in human serum and plasma to aid in diagnosis and treatment of androgen-related disorders, including hypogonadism, puberty disorders, cryptorchidism, ovarian hyperandrogenism, and erectile dysfunction in adult and pediatric populations.

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

• LIAISON® Testosterone (k122793)

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

K201908

B Applicant

DiaSorin Inc.

C Proprietary and Established Names

LIAISON® Testosterone xt

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: LIAISON® Testosterone (K122793).
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).
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

Food and Drug Administration

10903 New Hampshire Avenue

Silver Spring, MD 20993-0002

www.fda.gov

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demonstrate that the FUNDAMENTAL SCIENTIFIC TECHNOLOGY of the modified device has not changed. This change was for:

- Extending the assay measuring range from 0.16 - 15.0 ng/mL to 0.024 - 15.0 ng/mL.
- Extending the open use stability claim for the device from four (4) weeks up to eight (8) weeks when stored at 2-8° C.
- Extending open use stability of calibrators up to eight (8) weeks after opening when properly stored.
- Extending the calibration curve stability from seven (7) days up to four (4) weeks.
- Change of proprietary name from the LIAISON® Testosterone to LIAISON® Testosterone xt.

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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