Access Testosterone

K223405 · Beckman Coulter, Inc. · CDZ · Jan 13, 2023 · Clinical Chemistry

Device Facts

• Record ID: K223405
• Device Name: Access Testosterone
• Applicant: Beckman Coulter, Inc.
• Product Code: CDZ · Clinical Chemistry
• Decision Date: Jan 13, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1680
• Device Class: Class 1

Indications for Use

The Access Testosterone assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of total testosterone levels in human serum and plasma using the Access Immunoassay Systems. 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.

Device Story

Access Testosterone assay is a competitive binding immunoenzymatic assay; utilizes paramagnetic particles and chemiluminescence. Input: human serum or plasma samples. Operation: automated on Dxl 9000 Access Immunoassay Analyzer; reagent pack, calibrators, substrate (Lumi-Phos PRO), and wash buffer used. Output: quantitative total testosterone concentration. Used in clinical laboratory settings by trained laboratory personnel. Healthcare providers use results to diagnose/treat androgen-related conditions (e.g., hypogonadism, hirsutism, virilization). Benefits: provides standardized, automated measurement of testosterone levels to support clinical decision-making.

Clinical Evidence

Bench testing only. Method comparison study (n=108 serum samples) demonstrated equivalence to the predicate (R²=0.98, slope 0.95). Linearity verified across 0.4–16.0 ng/mL range. Precision studies (repeatability, within-run, between-run, between-day) met acceptance criteria (SD ≤ 0.14 ng/mL for concentrations ≤ 1.4 ng/mL; CV ≤ 10.0% for concentrations > 1.4 ng/mL). LoB 0.2 ng/mL, LoD 0.4 ng/mL, LoQ 0.4 ng/mL.

Technological Characteristics

Competitive binding chemiluminescent immunoassay. Paramagnetic particle-based. Automated. Analyte: Testosterone. Standardization: USP reference material. Measuring range: 0.4–16.0 ng/mL. Instrument: Dxl 9000 Access Immunoassay Analyzer. Substrate: Lumi-Phos PRO. Sample types: serum, plasma (heparin).

Indications for Use

Indicated for quantitative determination of total testosterone in human serum and plasma to aid in diagnosis and treatment of androgen-related disorders, including hypogonadism, puberty disorders, and impotence in males, and hirsutism and virilization in females.

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)

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# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION
## TRIAGE-QUICK REVIEW DECISION SUMMARY

510(k) Number: K223405

This 510(k) was reviewed under OHT7’s Triage-Quick Review 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.

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