ACTIVE CROSSLAPS ELISA

K960171 · Diagnostic Systems Laboratories, Inc. · JMM · Mar 28, 1996 · Clinical Chemistry

Device Facts

• Record ID: K960171
• Device Name: ACTIVE CROSSLAPS ELISA
• Applicant: Diagnostic Systems Laboratories, Inc.
• Product Code: JMM · Clinical Chemistry
• Decision Date: Mar 28, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1400
• Device Class: Class 1

Indications for Use

The DSL ACTIVE CrossLaps™ ELISA assay is intended for the quantitative determination of CrossLaps™ in human urine. The measurement of CrossLaps™ is used as an indicator of human bone resorption.

Device Story

In vitro diagnostic ELISA kit; competitive binding protein assay. Input: human urine sample. Mechanism: CrossLaps™ in sample competes with antigen-coated microtitration wells for enzyme-labeled CrossLaps™ antibody; separation via aspiration and washing; spectrophotometric analysis of bound absorbance. Output: quantitative concentration of CrossLaps™ (inversely proportional to absorbance). Used in clinical laboratory settings by trained technicians. Results assist clinicians in assessing bone resorption rates, aiding in the management of metabolic bone diseases.

Clinical Evidence

Bench testing only. Comparative study of 60 human urine samples using both DSL ACTIVE CrossLaps™ ELISA and OSTEX OSTEOMARK assay. Linear regression analysis: Y = 3.18(X) + 16.69; correlation coefficient (r) = 0.95.

Technological Characteristics

Competitive enzyme-linked immunosorbent assay (ELISA). Components: microtitration wells coated with antigen, enzyme-labeled CrossLaps™ antibody. Detection: spectrophotometric absorbance measurement. Format: 96-well microtiter plate.

Indications for Use

Indicated for the quantitative measurement of Type I Collagen Telopeptide (CrossLaps™) in human urine as an indicator of bone resorption in humans.

Regulatory Classification

Identification

A hydroxyproline test system is a device intended to measure the amino acid hydroxyproline in urine. Hydroxyproline measurements are used in the diagnosis and treatment of various collagen (connective tissue) diseases, bone disease such as Paget's disease, and endocrine disorders such as hyperparathyroidism and hyperthyroidism.

Predicate Devices

• OSTEX OSTEOMARK assay

Submission Summary (Full Text)

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Dl

K96C171

28

Diagnostic Systems Laboratories, Inc.

445 Medical Center Boulevard

Webster Texas 77598-4217 USA

Tel [phone]

Fax [phone]

Customer Assistance Center

Tel [phone]

Fax [phone]

# SUMMARY OF SAFETY AND EFFECTIVENESS

Name of Device: DSL 10-1700 ACTIVE CrossLaps™ ELISA Kit

Classification Name: Enzymeimmunoassay, Type I Collagen Telopeptide

Analyte Code and Name: Type I Collagen Telopeptide

Submitter: John Willis
Diagnostic Systems Laboratories, Inc.
445 Medical Center Boulevard
Webster, Texas 77598
Phone: [phone]

Date: March 15, 1996

The DSL ACTIVE CrossLaps™ ELISA kit was developed for the quantitative measurement of Type I Collagen Telopeptide (CrossLaps™) in human urine. The ELISA format is a competitive binding protein assay. CrossLaps™ in the urine sample competes with antigen coated to the microtitration wells for the enzyme labelled CrossLaps™ antibody. CrossLaps™ in the sample binds to the enzyme labelled antibody displacing it from binding to the antigen coated wells. Separation of free from bound CrossLaps™ is achieved by aspirating and washing the wells. The resultant is analyzed in a spectrophotometer for bound absorbance. The amount of enzyme-labeled CrossLaps™ bound to the microtiter well is inversely proportional to the concentration of the CrossLaps™ present in the sample.

The DSL ACTIVE CrossLaps™ ELISA assay is intended for the quantitative determination of CrossLaps™ in human urine. The measurement of CrossLaps™ is used as an indicator of human bone resorption.

The DSL 10-1700 ACTIVE CrossLaps™ ELISA is substantially equivalent to the OSTEX OSTEOMARK assay. Both kits are used in vitro as an indicator of human bone resorption.

To demonstrate substantial equivalence between the two assays, urine samples from sixty individuals were collected and assayed using both methods. Samples were chosen based on expected 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 $Y = 3.18(X) + 16.69$ with a correlation coefficient of (r) = 0.95.