Who is the manufacturer of DSL ACTIVE NON-EXTRACTION IGF-I IRMA?

Diagnostic Systems Laboratories, Inc. filed the 510(k) submission for DSL ACTIVE NON-EXTRACTION IGF-I IRMA (K961172).

What is the FDA product code for DSL ACTIVE NON-EXTRACTION IGF-I IRMA?

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 NON-EXTRACTION IGF-I IRMA?

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

Who can help prepare an FDA 510(k) submission like DSL ACTIVE NON-EXTRACTION IGF-I 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 NON-EXTRACTION IGF-I IRMA

K961172 · Diagnostic Systems Laboratories, Inc. · CFL · Apr 23, 1996 · Clinical Chemistry

Device Facts

Record ID	K961172
Device Name	DSL ACTIVE NON-EXTRACTION IGF-I IRMA
Applicant	Diagnostic Systems Laboratories, Inc.
Product Code	CFL · Clinical Chemistry
Decision Date	Apr 23, 1996
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 862.1370
Device Class	Class 1

Intended Use

The DSL IGF-I IRMA assay is intended for the quantitative determination of IGF-I in human serum or EDTA plasma. The measurement of serum/plasma IGF-I is used as a diagnostic aid in the evaluation of growth status disorders.

Device Story

DSL 2800 IGF-I IRMA kit; immunoradiometric capture assay. Input: human serum or EDTA plasma samples. Principle: IGF-I analyte captured between immobilized mouse monoclonal antibody on test tube surface and Iodine-125 labeled goat-anti-IGF-I polyclonal antibody. Output: quantitative IGF-I concentration. Used in clinical laboratory settings by trained technicians. Results assist clinicians in diagnosing and monitoring growth status disorders.

Clinical Evidence

Bench-only study comparing subject device to predicate (DSL 5600). Sample size n=146 patient samples covering low, intermediate, and high IGF-I levels. Linear regression analysis: Y = 1.19(X) - 22.07; correlation coefficient (r) = 0.98.

Technological Characteristics

Immunoradiometric assay (IRMA) format. Capture mechanism: mouse monoclonal antibody immobilized on test tube surface; detection via Iodine-125 labeled goat-anti-IGF-I polyclonal antibody. Analyte: Insulin-like Growth Factor-I.

Indications for Use

Indicated for quantitative measurement of IGF-I in human serum or EDTA plasma to aid in evaluating growth status disorders in patients.

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 5600 IGF-I IRMA

Related Devices

K971353 — DSL ACTIVE NON-EXTRACTION IGF-I ELISA · Diagnostic Systems Laboratories, Inc. · May 12, 1997
K970701 — DSL 1900 ACTIVE HUMAN GROWTH HORMONE IRMA (DSL 1900) · Diagnostic Systems Laboratories, Inc. · Apr 2, 1997
K962758 — DSL 9100 IGF-II IRMA · Diagnostic Systems Laboratories, Inc. · Aug 30, 1996
K960551 — DSL ACTIVE HUMAN GROWTH HORMONE ELISA · Diagnostic Systems Laboratories, Inc. · Mar 6, 1996
K170938 — CalSet IGF-1 · Roche Diagnostics · Apr 26, 2017

Submission Summary (Full Text)

{0} K96/172 APR 22 1996 # SUMMARY OF SAFETY AND EFFECTIVENESS Name of Device: DSL 2800 IGF-I IRMA Kit Classification Name: Immunoradiometric, IGF-I Analyte Name: Insulin-like Growth Factor-I Regulatory Class: Submitter: John Willis Diagnostic Systems Laboratories, Inc. 445 Medical Center Boulevard Webster, Texas 77598 Phone: 713-332-9678 Date: March 22, 1996 The DSL Active IGF-I IRMA kit was developed for the quantitative measurement of Insulin-like Growth Factor-I in human serum and plasma. This IRMA format is a capture assay. Mouse monoclonal antibody to IGF-I is immobilized to the inner surface of the coated test tubes. IGF-I in the standards or samples is "sandwiched" between this monoclonal and the goat-anti-IGF-I polyclonal antibody labelled with Iodine-125. The DSL IGF-I IRMA assay is intended for the quantitative determination of IGF-I in human serum or EDTA plasma. The measurement of serum/plasma IGF-I is used as a diagnostic aid in the evaluation of growth status disorders. The DSL IGF-I IRMA is substantially equivalent to the DSL 5600 IGF-I IRMA. These kits have the same intended use. To demonstrate substantial equivalence between the two assays, patient samples (n=146) were collected and assayed simultaneously by both methods. Samples were chosen based on expected IGF-I levels so that samples with low, intermediate and high levels of IGF-I would be evaluated. Linear regression analysis of the results obtained for the comparison with the IGF-1 assay gave the equation $Y = 1.19(X) - 22.07$ with a correlation coefficient of $(r) = 0.98$.