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

Diagnostic Systems Laboratories, Inc. submitted the Traditional clearance for DSL ACTIVE I-HCG ELISA (K961911).

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

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 ELISA?

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

DSL ACTIVE I-HCG ELISA

K961911 · Diagnostic Systems Laboratories, Inc. · JHI · Jun 28, 1996 · Clinical Chemistry

Device Facts

Record ID	K961911
Device Name	DSL ACTIVE I-HCG ELISA
Applicant	Diagnostic Systems Laboratories, Inc.
Product Code	JHI · Clinical Chemistry
Decision Date	Jun 28, 1996
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 862.1155
Device Class	Class 2

Intended Use

The DSL I-hCG ELISA 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 10-8300 I-hCG ELISA kit; quantitative measurement of hCG in human serum. Non-competitive sandwich ELISA format; analyte captured between immobilized antibody on microtitration well wall and horseradish peroxidase-conjugated antibody. Unbound materials removed via washing; spectrophotometer measures absorbance. Absorbance directly proportional to hCG concentration. Used in clinical laboratory settings by professional personnel. Output aids clinicians in pregnancy detection.

Clinical Evidence

Bench testing only. Comparative study of 54 patient serum samples using DSL I-hCG ELISA and DSL I-hCG IRMA. Samples spanned low, intermediate, and high hCG concentrations. Linear regression analysis showed correlation coefficient r = 0.98.

Technological Characteristics

Enzyme-linked immunosorbent assay (ELISA). Non-competitive sandwich format. Components: microtitration wells with immobilized antibody, horseradish peroxidase-conjugated antibody. Detection via spectrophotometry. In vitro diagnostic kit.

Indications for Use

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

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

DSL I-hCG IRMA

Related Devices

K960357 — DSL ACTIVE I-HCG IRMA · Diagnostic Systems Laboratories, Inc. · May 7, 1996
K991741 — BIOCHECK HCG ENZYME IMMUNOASSAY TEST KIT, MODEL BC-1027 · Biocheck, Inc. · Jul 22, 1999
K020128 — ACTIVE FREE BETA-HCG ELISA, MODEL DSL-10-8500 · Diagnostic Systems Laboratories, Inc. · Mar 1, 2002
K221990 — Access Total ßhCG (5th IS) · Beckman Coulter, Inc. · Dec 27, 2022

Submission Summary (Full Text)

{0} Diagnostic Systems Laboratories, Inc. 445 Medical Center Boulevard Webster, Texas 77598-4217 US Tel 713.332.9677 Fax 713.554.4277 Customer Assistance Center Tel 800.231.797 Fax 713.338.189 # SUMMARY OF SAFETY AND EFFECTIVENESS Name of Device: DSL 10-8300 I-hCG ELISA Kit Classification Name: Enzymeimmunoassay, 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: May 15, 1996 The DSL I-hCG ELISA kit was developed for the quantitative measurement of I-hCG in human serum. The ELISA 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 microtitration well, the other antibody is conjugated to the enzyme horseradish peroxidase for detection. The analyte present is bound by both the antibodies to form a "sandwiched" complex. Unbound materials are removed by washing the wells. The resultant is analyzed in a spectrophotometer for absorbance. The amount of bound hCG is directly proportional to the concentration of the hCG present in the sample. The DSL I-hCG ELISA 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 ELISA is substantially equivalent to the DSL I-hCG IRMA. To demonstrate substantial equivalence between the two assays, patient samples (n=54) 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 $Y = 0.92(X) + 16.5$ with a correlation coefficient of $(r) = 0.98$.