Who is the manufacturer of DSL ACTIVE HUMAN GROWTH HORMONE ELISA?

Diagnostic Systems Laboratories, Inc. filed the 510(k) submission for DSL ACTIVE HUMAN GROWTH HORMONE ELISA (K960551).

What is the FDA product code for DSL ACTIVE HUMAN GROWTH HORMONE ELISA?

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 ACTIVE HUMAN GROWTH HORMONE ELISA?

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

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

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 HUMAN GROWTH HORMONE ELISA

K960551 · Diagnostic Systems Laboratories, Inc. · CFL · Mar 6, 1996 · Clinical Chemistry

Device Facts

Record ID	K960551
Device Name	DSL ACTIVE HUMAN GROWTH HORMONE ELISA
Applicant	Diagnostic Systems Laboratories, Inc.
Product Code	CFL · Clinical Chemistry
Decision Date	Mar 6, 1996
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 862.1370
Device Class	Class 1

Intended Use

The DSL Active hGH ELISA Kit was developed for the quantitative measurement of human growth hormone in human serum. The measurement of growth hormone in serum is used as a diagnostic aid in the evaluation of hGH deficiency disorders or acromegaly.

Device Story

DSL 10-1900 hGH ELISA Kit; quantitative measurement of human growth hormone in human serum. Principle: sandwich enzyme-linked immunosorbent assay (ELISA). Mouse monoclonal capture antibody immobilized on microtiter plate wells; serum sample or standard added; anti-hGH monoclonal antibody conjugated to horseradish peroxidase (HRP) added. Enzyme activity measured to determine hGH concentration. Used in clinical laboratory settings by trained personnel. Output: quantitative hGH concentration. Clinical utility: diagnostic aid for hGH deficiency or acromegaly.

Clinical Evidence

Method comparison study; 41 patient samples; samples spanned low, medium, and high hGH levels. Comparison between DSL hGH ELISA and Nichols Institute hGH IRMA. Results: linear regression Y = 1.06x + 0.25; correlation coefficient r = 0.99.

Technological Characteristics

Sandwich ELISA; mouse monoclonal capture antibody; HRP-conjugated monoclonal detection antibody; microtiter plate format. Quantitative measurement via enzymatic reaction.

Indications for Use

Indicated for the quantitative measurement of human growth hormone (hGH) in human serum to aid in the 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

Nichols Institute hGH IRMA

Related Devices

K970701 — DSL 1900 ACTIVE HUMAN GROWTH HORMONE IRMA (DSL 1900) · Diagnostic Systems Laboratories, Inc. · Apr 2, 1997
K971353 — DSL ACTIVE NON-EXTRACTION IGF-I ELISA · Diagnostic Systems Laboratories, Inc. · May 12, 1997
K961172 — DSL ACTIVE NON-EXTRACTION IGF-I IRMA · Diagnostic Systems Laboratories, Inc. · Apr 23, 1996
K961911 — DSL ACTIVE I-HCG ELISA · Diagnostic Systems Laboratories, Inc. · Jun 28, 1996
K972761 — SEALITE SCIENCES, INC. AQUALITE HUMAN GROWTH HORMONE ASSAY · Sealite Sciences, Inc. · Sep 25, 1997

Submission Summary (Full Text)

{0} D K960551 Diagnostic Systems Laboratories, Inc. 145 Medical Center Boulevard Webster, Texas 77598 121/18 Tel 713.332.9678 Fax 713.554.4320 Customer Assistance Center Tel 800.231.797 Fax 713.338.1896 # SUMMARY OF SAFETY AND EFFECTIVENESS Name of Device: DSL 10-1900 hGH ELISA Kit. Classification Name: Enzyme-Linked Immunosorbent Assay, hGH. Analyte Name: Human Growth Hormone. Regulatory Class: I Submitter: John Willis Diagnostic Systems Laboratories, Inc. 445 Medical Center Blvd. Webster, Texas 77598 Phone: (713) 332-9678 Date: February 7, 1996 The DSL Active hGH ELISA Kit was developed for the quantitative measurement of human growth hormone in human serum. Mouse monoclonal antibody "capture antibody" is immobilized to the inner surface of microtiter plate wells. Growth hormone in the standards or serum samples is "sandwiched" between the capture antibody and the anti-hGH monoclonal antibody conjugated to horseradish peroxidase enzyme. The measurement of growth hormone in serum is used as a diagnostic aid in the evaluation of hGH deficiency disorders or acromegaly. The DSL hGH ELISA is substantially equivalent to the Nichols Institute hGH IRMA. These kits have the same intended use. To demonstrate substantial equivalence between the two assays, 41 patient samples were collected and assayed simultaneously by both methods. Samples were chosen with low medium and high levels of hGH. Linear regression analysis of the results obtained for the comparison yield the following results: $Y = 1.06x + 0.25$ with a correlation coefficient of 0.99. ![img-0.jpeg](img-0.jpeg)