Who is the manufacturer of DSL ACTIVE FSH IRMA?

Diagnostic Systems Laboratories, Inc. filed the 510(k) submission for DSL ACTIVE FSH IRMA (K962118).

What is the FDA product code for DSL ACTIVE FSH IRMA?

CGJ. It is classified under 21 CFR 862.1300 as a Class 1 device in the Clinical Chemistry panel.

What is the regulatory pathway for DSL ACTIVE FSH IRMA?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like DSL ACTIVE FSH IRMA?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

DSL ACTIVE FSH IRMA

K962118 · Diagnostic Systems Laboratories, Inc. · CGJ · Sep 9, 1996 · Clinical Chemistry

Device Facts

Record ID	K962118
Device Name	DSL ACTIVE FSH IRMA
Applicant	Diagnostic Systems Laboratories, Inc.
Product Code	CGJ · Clinical Chemistry
Decision Date	Sep 9, 1996
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 862.1300
Device Class	Class 1

Intended Use

The DSL FSH IRMA assay is intended for the quantitative determination of FSH in human serum. The measurement of FSH is used as a diagnostic aid in the diagnosis and treatment of pituitary gland and gonadal disorders.

Device Story

DSL 4700 FSH IRMA kit; non-competitive immunoradiometric assay (IRMA) for quantitative FSH measurement in human serum. Principle: analyte sandwiched between immobilized antibody on test tube wall and radiolabelled detection antibody. Process: sample incubation; decanting/washing to remove unbound material; gamma counter analysis of bound counts per minute. Output: FSH concentration directly proportional to bound counts. Used in clinical laboratory settings by trained technicians. Results assist physicians in diagnosing/treating pituitary and gonadal disorders.

Clinical Evidence

Bench testing only. Comparative study of 81 patient serum samples using DSL 4700 FSH IRMA and DPC FSH IMMULITE. Linear regression analysis: Y = 0.66(X) + 1.26; r = 0.98.

Technological Characteristics

Non-competitive immunoradiometric assay (IRMA). Components: test tubes with immobilized antibody, radiolabelled detection antibody. Detection via gamma counter. Quantitative measurement based on sandwich complex formation.

Indications for Use

Indicated for quantitative determination of FSH in human serum as a diagnostic aid for pituitary gland and gonadal disorders in patients requiring FSH level assessment.

Regulatory Classification

Identification

A follicle-stimulating hormone test system is a device intended to measure follicle-stimulating hormone (FSH) in plasma, serum, and urine. FSH measurements are used in the diagnosis and treatment of pituitary gland and gonadal disorders.

Predicate Devices

DPC FSH IMMULITE

Related Devices

K961109 — ACTIVE LH IRMA · Diagnostic Systems Laboratories, Inc. · Apr 5, 1996
K972720 — FOLLICLE STIMULATING HORMONE (FSH) MICROPLATE ELISA (425-300) · Monobind · Sep 2, 1997
K960357 — DSL ACTIVE I-HCG IRMA · Diagnostic Systems Laboratories, Inc. · May 7, 1996
K970701 — DSL 1900 ACTIVE HUMAN GROWTH HORMONE IRMA (DSL 1900) · Diagnostic Systems Laboratories, Inc. · Apr 2, 1997
K964693 — ELECSYS FSH ASSAY · Boehringer Mannheim Corp. · Dec 16, 1996

Submission Summary (Full Text)

{0} Dl SEP - 9 1996 K962118 Diagnostic Systems Laboratories, Inc. 445 Medical Center Boulevard Webster Texas 77598-4217 USA Tel 713.332.9678 Fax 713.554.4220 Customer Assistance Center Tel 800.231.7970 Fax 713.338.1895 # SUMMARY OF SAFETY AND EFFECTIVENESS Name of Device: DSL 4700 FSH IRMA Kit Classification Name: Immunoradiometric Assay, FSH Analyte Code and Name: Follicle Stimulating Hormone Regulatory Class: I Submitter: John Willis Diagnostic Systems Laboratories, Inc. 445 Medical Center Boulevard Webster, Texas 77598 Phone: 713-332-9678 Date: May 29, 1996 The DSL FSH IRMA kit was developed for the quantitative measurement of FSH in human serum. The IRMA format is a non-competitive assay in which the analyte to be measured is "sandwiched" between two antibodies. The first antibody is immobilized to the inside wall of the test tube, the other antibody is radiolabelled for detection. The analyte present is bound by both the antibodies to form a "sandwiched" complex. Unbound materials are removed by decanting and washing the tubes. The resultant is analyzed in a gamma counter for bounds counts per minute. The amount of bound FSH is directly proportional to the concentration of the FSH present in the sample. The DSL FSH IRMA assay is intended for the quantitative determination of FSH in human serum. The measurement of FSH is used as a diagnostic aid in the diagnosis and treatment of pituitary gland and gonadal disorders. The DSL FSH IRMA is substantially equivalent to the DPC FSH IMMULITE. To demonstrate substantial equivalence between the two assays, patient samples (n=81) were collected and assayed using both methods. Samples were chosen based on expected FSH levels so that samples with low, intermediate and high levels would be evaluated. Linear regression analysis of the results obtained for the comparison gave the equation $Y = 0.66(X) + 1.26$ with a correlation coefficient of $(r) = 0.98$.