Who is the manufacturer of ACTIVE CROSSLAPS ELISA?

Diagnostic Systems Laboratories, Inc. filed the 510(k) submission for ACTIVE CROSSLAPS ELISA (K960171).

What is the FDA product code for ACTIVE CROSSLAPS ELISA?

JMM. It is classified under 21 CFR 862.1400 as a Class 1 device in the Clinical Chemistry panel.

What is the regulatory pathway for ACTIVE CROSSLAPS ELISA?

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

Who can help prepare an FDA 510(k) submission like ACTIVE CROSSLAPS 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.

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

Intended 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

Related Devices

K972788 — CROSSLAPS ELISA · Devices and Diagnostics Consulting Group · Dec 22, 1998
K990843 — SERUM CROSSLAPS ONE STEP ELISA · Osteometer Biotech A/S · Jul 9, 1999
K963251 — CIBA CORNING ACS;180 DPD ASSAY · Ciba Corning Diagnostics Corp. · Oct 15, 1996
K983674 — VITROS IMMUNODIAGNOSTIC PRODUCTS: NTX CALIBRATORS, NTX REAGENT PACK, NTX CONTROLS · Ortho-Clinical Diagnostics, Inc. · Jan 29, 1999
K993706 — ELECSYS SERUM B-CROSSLAPS/SERUM IMMUNOASSAY · Roche Diagnostics Corp. · Jul 24, 2000

Submission Summary (Full Text)

{0} Dl K96C171 28 Diagnostic Systems Laboratories, Inc. 445 Medical Center Boulevard Webster Texas 77598-4217 USA Tel 713.332.9678 Fax 713.554.4220 Customer Assistance Center Tel 800.231.7970 Fax 713.338.1895 # 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: 713-332-9678 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.