Who is the manufacturer of DSL ACTIVE I-HCG IRMA?

Diagnostic Systems Laboratories, Inc. filed the 510(k) submission for DSL ACTIVE I-HCG IRMA (K960357).

What is the FDA product code for DSL ACTIVE I-HCG IRMA?

JHI. It is classified under 21 CFR 862.1155 as a Class 2 device in the Clinical Chemistry panel.

What is the regulatory pathway for DSL ACTIVE I-HCG IRMA?

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

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

K960357 · Diagnostic Systems Laboratories, Inc. · JHI · May 7, 1996 · Clinical Chemistry

Device Facts

Record ID	K960357
Device Name	DSL ACTIVE I-HCG IRMA
Applicant	Diagnostic Systems Laboratories, Inc.
Product Code	JHI · Clinical Chemistry
Decision Date	May 7, 1996
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 862.1155
Device Class	Class 2

Intended Use

The DSL I-hCG IRMA assay is intended for the quantitative determination of I-hCG in human serum. It is intended for in vitro diagnostic use by professional laboratory personnel as an aid in the detection of pregnancy.

Device Story

DSL 8300 I-hCG IRMA kit; non-competitive immunoradiometric assay (IRMA) for quantitative hCG measurement in human serum. Principle: 'sandwich' immunoassay using two antibodies; one immobilized on test tube wall, one radiolabeled for detection. Procedure: sample incubation; decanting/washing to remove unbound material; gamma counter analysis of bound counts per minute. Output: hCG concentration directly proportional to bound counts. Used in clinical laboratories by professional personnel. Results aid clinicians in pregnancy detection.

Clinical Evidence

Bench testing only. Comparative study of 53 patient serum samples analyzed by both DSL 8300 I-hCG IRMA and predicate DPC hCG IRMA. Results showed strong correlation (r=0.96) with linear regression equation Y = 0.86(X) + 9.5.

Technological Characteristics

Non-competitive immunoradiometric assay (IRMA). Components: antibody-coated test tubes, radiolabeled antibody reagent. Detection via gamma counter. In vitro diagnostic use.

Indications for Use

Indicated for the quantitative measurement of human chorionic gonadotropin (hCG) in human serum to aid in the detection of pregnancy in clinical laboratory settings.

Regulatory Classification

Identification

A human chorionic gonadotropin (HCG) test system is a device intended for the early detection of pregnancy is intended to measure HCG, a placental hormone, in plasma or urine. A human chorionic goadotropin (HCG) test system is a device intended for any uses other than early detection of pregnancy (such as an aid in the diagnosis, prognosis, and management of treatment of persons with certain tumors or carcinomas) is intended to measure HCG, a placental hormone, in plasma or urine.

Predicate Devices

DPC hCG IRMA

Related Devices

K961911 — DSL ACTIVE I-HCG ELISA · Diagnostic Systems Laboratories, Inc. · Jun 28, 1996
K223690 — iFlash-HCG; Chemiluminescence Immunoassay Analyzer (Model: iFlash 3000-C) · Shenzhen Yhlo Biotech Co., Ltd. · Dec 11, 2023
K131037 — LIAISON XL HCG · DiaSorin, Inc. · Sep 6, 2013
K172322 — Atellica IM Total hCG (ThCG) · Siemens Healthcare Diagnostics, Inc. · Mar 29, 2018

Submission Summary (Full Text)

{0} K960357 MAY - 7 1996 Diagnostic Systems Laboratories, Inc. 445 Medical Center Boulevard Webster, Texas 77598-4217 Tel 713.332.7678 Fax 713.554.4220 Customer Assistance Center Tel 800.231.7970 Fax 713.338.1895 # SUMMARY OF SAFETY AND EFFECTIVENESS Name of Device: DSL 8300 I-hCG IRMA Kit Classification Name: Radioimmunoassay, Human Chorionic Gonadotropin Analyte Code and Name: Human Chorionic Gonadotropin Regulatory Class: II Submitter: John Willis Diagnostic Systems Laboratories, Inc. 445 Medical Center Boulevard Webster, Texas 77598 Phone: 713-332-9678 Date: January 24, 1996 The DSL I-hCG IRMA kit was developed for the quantitative measurement of I-hCG 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 hCG is directly proportional to the concentration of the hCG present in the sample. The DSL I-hCG IRMA assay is intended for the quantitative determination of I-hCG in human serum. It is intended for in vitro diagnostic use by professional laboratory personnel as an aid in the detection of pregnancy. The DSL I-hCG IRMA is substantially equivalent to the DPC hCG IRMA. To demonstrate substantial equivalence between the two assays, patient samples (n=53) were collected and assayed using both methods. Samples were chosen based on expected hCG 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 $Y = 0.86(X) + 9.5$ with a correlation coefficient of (r) = 0.96.