Who is the manufacturer of CIBA CORNING ACS;180 DPD ASSAY?

Ciba Corning Diagnostics Corp. filed the 510(k) submission for CIBA CORNING ACS;180 DPD ASSAY (K963251).

What is the FDA product code for CIBA CORNING ACS;180 DPD ASSAY?

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 CIBA CORNING ACS;180 DPD ASSAY?

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

What are the predicate devices for CIBA CORNING ACS;180 DPD ASSAY?

Pyrilinks®-D (Metra Biosystems, Inc).

Who can help prepare an FDA 510(k) submission like CIBA CORNING ACS;180 DPD ASSAY?

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.

CIBA CORNING ACS;180 DPD ASSAY

K963251 · Ciba Corning Diagnostics Corp. · JMM · Oct 15, 1996 · Clinical Chemistry

Device Facts

Record ID	K963251
Device Name	CIBA CORNING ACS;180 DPD ASSAY
Applicant	Ciba Corning Diagnostics Corp.
Product Code	JMM · Clinical Chemistry
Decision Date	Oct 15, 1996
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 862.1400
Device Class	Class 1

Intended Use

The intended use of Ciba Corning Ciba Corning ACS:180 DPD Assay is for the quantitative of deoxypyridinoline (DPD) in urine using the Ciba Corning ACS:180 automated chemiluminescence systems

Device Story

Competitive immunoassay using direct chemiluminescent technology; performed on ACS:180 automated system. Input: urine sample. Mechanism: DPD in sample competes with pyridinoline bound to paramagnetic particles for monoclonal mouse anti-DPD antibody labeled with acridinium ester. Output: relative light units (RLUs) inversely proportional to DPD concentration. Used in clinical laboratory settings by trained technicians. Results assist clinicians in evaluating bone resorption status.

Clinical Evidence

Bench testing only. Method comparison performed on 752 urine samples (range 6-350 nM) against an alternate ELISA method; correlation coefficient r=0.961; regression equation: y=1.05x + 2.13. Total precision (%CV) ranged from 2.84% to 9.76%. Analytical sensitivity (minimum detectable concentration) is 5.0 nM.

Technological Characteristics

Competitive chemiluminescent immunoassay. Components: paramagnetic particles, monoclonal mouse anti-DPD antibody, acridinium ester-labeled goat anti-mouse antibody. Automated system (ACS:180) measures light output (RLUs).

Indications for Use

Indicated for the quantitative measurement of deoxypyridinoline (DPD) in urine samples to assess bone resorption.

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

Pyrilinks®-D (Metra Biosystems, Inc)

Related Devices

K971312 — IMMULITE PYRILINKS-D · Diagnostic Products Corp. · May 27, 1997
K980833 — IMMULITE PYRILINKS-D MODEL NUMBERS LKPD1, LKPD5 · Diagnostic Products Corp. · May 1, 1998
K972580 — DEOXYPYRIDINOLINE ASSAY FOR THE BAYER IMMUNO 1 SYSTEM · Bayer Corp. · Sep 22, 1997
K960171 — ACTIVE CROSSLAPS ELISA · Diagnostic Systems Laboratories, Inc. · Mar 28, 1996
K974260 — PYRILINKS-D ASSAY KIT · Metra Biosystems, Inc. · Jan 26, 1998

Submission Summary (Full Text)

{0} Company Confidential K963251 OCT 15 1996 # Summary of Safety and Effectiveness As required by 21 CFR 807.92, the following 510(k) Summary is provided: ## 1. Submitters Information Contact person: William J. Pignato Director of Regulatory Affairs Address: Ciba Corning Diagnostics Corp. 63 North Street Medfield, MA 02052 Phone: 508 359-3825 Date Summary Prepared: August 15, 1996 ## 2. Device Information Proprietary Name: Ciba Corning ACS:180 DPD Assay Common Name: Assay for Deoxypyridinoline ## 3. Predicate Device Information Name: Pyrilinks®-D Manufacturer: Metra Biosystems, Inc ## 4. Device Description The Ciba Corning ACS:180 DPD assay is a competitive immunoassay using direct, competitive chemiluminescent technology. DPD in the patient sample competes with pyridinoline bound to the paramagnetic particles in the Solid Phase for a limited amount of monoclonal mouse anti-DPD antibody in the Lite Reagent. The monoclonal mouse anti-DPD is bound to goat anti-mouse antibody labeled with acridinium ester. An inverse relationship exists between the amount of DPD present in the sample and the amount of relative light units (RLUs) detected by the system. ## 5. Statement of Intended Use The intended use of Ciba Corning Ciba Corning ACS:180 DPD Assay is for the quantitative of deoxypyridinoline (DPD) in urine using the Ciba Corning ACS:180 automated chemiluminescence systems Ciba Corning ACS:180 DPD August 15, '996 Page 2 {1} Company Confidential ## 6. Summary of Technological Characteristics The Ciba Corning ACS:180 DPD assay is a competitive immunoassay using direct, competitive chemiluminescent technology ## 7. Performance Characteristics ### Sensitivity The ACS:180 DPD assay measures DPD concentrations up to 350 nM with a minimum detectable concentration of 5.0 nM. Analytical sensitivity is defined as the concentration of DPD that corresponds to the RLUs that are two standard deviations less than the mean RLUs of 20 replicate determinations of the DPD zero standard. ### Method Comparison For 752 urine samples in the range of 6 to 350 nM, the relationship between ACS:180 DPD and an alternate ELISA method is described by the equation: $$ \text{ACS:180 DPD} = 1.05 \times (\text{alternate method}) + 2.13 $$ Correlation coefficient (r) = 0.961 ### Precision Total precision (%CV) ranged from 2.84 to 9.76 Ciba Corning ACS:180 DPD August 15, '996 Page 3