Who is the manufacturer of DSL 1900 ACTIVE HUMAN GROWTH HORMONE IRMA (DSL 1900)?

Diagnostic Systems Laboratories, Inc. filed the 510(k) submission for DSL 1900 ACTIVE HUMAN GROWTH HORMONE IRMA (DSL 1900) (K970701).

What is the FDA product code for DSL 1900 ACTIVE HUMAN GROWTH HORMONE IRMA (DSL 1900)?

CFL. It is classified under 21 CFR 862.1370 as a Class 1 device in the Clinical Chemistry panel.

What is the regulatory pathway for DSL 1900 ACTIVE HUMAN GROWTH HORMONE IRMA (DSL 1900)?

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

Who can help prepare an FDA 510(k) submission like DSL 1900 ACTIVE HUMAN GROWTH HORMONE IRMA (DSL 1900)?

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 1900 ACTIVE HUMAN GROWTH HORMONE IRMA (DSL 1900)

K970701 · Diagnostic Systems Laboratories, Inc. · CFL · Apr 2, 1997 · Clinical Chemistry

Device Facts

Record ID	K970701
Device Name	DSL 1900 ACTIVE HUMAN GROWTH HORMONE IRMA (DSL 1900)
Applicant	Diagnostic Systems Laboratories, Inc.
Product Code	CFL · Clinical Chemistry
Decision Date	Apr 2, 1997
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 862.1370
Device Class	Class 1

Intended Use

The DSL hGH IRMA assay is intended for the quantitative determination of hGH in human serum. The measurement of hGH is used as a diagnostic aid in the evaluation of hGH deficiency disorders or acromegaly.

Device Story

DSL 1900 hGH IRMA kit; non-competitive immunoradiometric assay (IRMA) for quantitative hGH measurement in human serum. Analyte sandwiched between immobilized antibody (coated tube) and radiolabelled antibody; unbound material removed via decanting/washing. Gamma counter measures net counts; bound hGH concentration directly proportional to counts. Used in clinical laboratory settings by trained personnel. Results aid clinicians in evaluating hGH deficiency or acromegaly.

Clinical Evidence

Bench testing only. Comparative study of 68 human serum samples using subject IRMA kit and predicate ELISA. Linear regression analysis: Y = 0.93(predicate) - 0.19; r = 0.97.

Technological Characteristics

Non-competitive immunoradiometric assay (IRMA). Components: antibody-coated tubes, radiolabelled antibody. Detection via gamma counter. Quantitative measurement based on direct proportionality between bound hGH and net counts.

Indications for Use

Indicated for quantitative measurement of hGH in human serum to aid in diagnosis of hGH deficiency disorders or acromegaly.

Regulatory Classification

Identification

A human growth hormone test system is a device intended to measure the levels of human growth hormone in plasma. Human growth hormone measurements are used in the diagnosis and treatment of disorders involving the anterior lobe of the pituitary gland.

Predicate Devices

DSL 10-1900 hGH ELISA

Related Devices

K960551 — DSL ACTIVE HUMAN GROWTH HORMONE ELISA · Diagnostic Systems Laboratories, Inc. · Mar 6, 1996
K961172 — DSL ACTIVE NON-EXTRACTION IGF-I IRMA · Diagnostic Systems Laboratories, Inc. · Apr 23, 1996
K962118 — DSL ACTIVE FSH IRMA · Diagnostic Systems Laboratories, Inc. · Sep 9, 1996
K971353 — DSL ACTIVE NON-EXTRACTION IGF-I ELISA · Diagnostic Systems Laboratories, Inc. · May 12, 1997
K960357 — DSL ACTIVE I-HCG IRMA · Diagnostic Systems Laboratories, Inc. · May 7, 1996

Submission Summary (Full Text)

{0} D K970701 Diagnostic Systems Laboratories, Inc. 445 Medical Center Boulevard Webster Texas 77598-4217 USA Tel 281.332.9678 Fax 281.554.4220 Customer Assistance Center Tel 800.231.7970 Fax 281.338.1895 Email mktg@dslabs.com APR - 2 1997 # SUMMARY OF SAFETY AND EFFECTIVENESS Name of Device: DSL 1900 hGH IRMA Kit Classification Name: Immunoradiometric Assay for hGH Analyte Code and Name: hGH Regulatory Class: I Submitter: John Willis Diagnostic Systems Laboratories, Inc. 445 Medical Center Boulevard Webster, Texas 77598 Phone: 281-332-9678 Date: February 25, 1997 The DSL hGH IRMA kit was developed for the quantitative measurement of hGH 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 coated 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 tube. The resultant is analyzed in a gamma counter for net counts. The amount of bound hGH is directly proportional to the concentration of the hGH present in the sample. The DSL hGH IRMA assay is intended for the quantitative determination of hGH in human serum. The measurement of hGH is used as a diagnostic aid in the evaluation of hGH deficiency disorders or acromegaly. The DSL 1900 hGH IRMA is substantially equivalent to the DSL 10-1900 hGH ELISA. To demonstrate substantial equivalence between the two assays, human serum samples (n=68) were collected and assayed using both methods. Samples were chosen based on expected hGH 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 $Y = 0.93$ (DSL 10-1900) - 0.19 with a correlation coefficient of (r) = 0.97.