← Product Code [CIN](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CIN) · K964764 # OPUS BONE ALP (K964764) _Behring Diagnostics, Inc. · CIN · Jan 24, 1997 · Clinical Chemistry · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CIN/K964764 ## Device Facts - **Applicant:** Behring Diagnostics, Inc. - **Product Code:** [CIN](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CIN.md) - **Decision Date:** Jan 24, 1997 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 862.1050 - **Device Class:** Class 2 - **Review Panel:** Clinical Chemistry ## Indications for Use OPUS Bone ALP is an in vitro fluorogenic enzyme immunoassay (ELISA) for the quantitative measurement of bone alkaline phosphatase (bone ALP) in human serum as an aid in the management of patients with diagnosed Paget's disease. OPUS Bone ALP is intended for use with the OPUS analyzers. ## Device Story OPUS Bone ALP is an in vitro fluorogenic enzyme immunoassay (ELISA) reagent kit used with OPUS immunoassay analyzers. It measures bone alkaline phosphatase (bone ALP) in human serum. The device utilizes a two-site sandwich immunoassay principle with an enzyme-labeled mouse monoclonal antibody. The system is fully automated, performing fluorometric analysis to quantify bone ALP levels. Results assist clinicians in managing patients with Paget's disease. The device provides quantitative data to monitor disease status or treatment response. ## Clinical Evidence Bench testing only. Precision: Intra-assay %CV 2.7-5.23%; Inter-assay %CV 4.57-7.06%. Accuracy by recovery: 98-103%. Correlation: Compared to commercial immunoassay (n=50, range 5.83-115 ng/ml), correlation coefficient r=0.992, slope 1.06, y-intercept 0.77. ## Technological Characteristics In vitro fluorogenic enzyme immunoassay (ELISA). Reagents used with automated fluorometric OPUS analyzer. Employs two-site sandwich immunoassay principle with enzyme-labeled mouse monoclonal antibody. Six-level calibrator system. Tri-level control included. ## Regulatory Identification An alkaline phosphatase or isoenzymes test system is a device intended to measure alkaline phosphatase or its isoenzymes (a group of enzymes with similar biological activity) in serum or plasma. Measurements of alkaline phosphatase or its isoenzymes are used in the diagnosis and treatment of liver, bone, parathyroid, and intestinal diseases. ## Predicate Devices - Hybritech Tandem-R Ostase ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} Behring Diagnostics Inc. OPUS® Bone ALP 510(k) Notification K964764 510(k) Summary for OPUS Bone ALP JAN 24 1997 1. Manufactures Name, Address, Telephone, and contact person, date of preparation: Manufacturer: Behring Diagnostics Inc. 151 University Avenue Westwood, MA 02090 617-320-3117 Attn: Ruth Forstadt Preparation date: November 26, 1996 2. Device Name/ Classification: OPUS Bone ALP: Alkaline Phosphatase or Isoenzmes Test System Classification Number: Class II (862.1050) 3. Identification of the legally marketed device: Hybritech Tandem-R Ostase 4. Proposed Device Description: OPUS Bone ALP is a set of reagents intended to be used together with the OPUS immunoassay analyzers for the quantitative measurement of bone alkaline phosphatase (bone ALP) in human serum. 5. Proposed Device Intended Use: OPUS Bone ALP is an in vitro fluorogenic enzyme immunoassay (ELISA) for the quantitative measurement of bone alkaline phosphatase (bone ALP) in human serum as an aid in the management of patients with diagnosed Paget's disease. OPUS Bone ALP is intended for use with the OPUS analyzers. 000012 CONFIDENTIAL {1} Behring Diagnostics Inc. OPUS® Bone ALP 510(k) Notification ## 6. Medical device to which equivalence is claimed and comparison information: The OPUS Bone ALP assay is substantially equivalent in intended use to results obtained using the Hybritech Tandem-R Ostase. The Hybritech Tandem-R Ostase, like the proposed product, employs the principle of two site or sandwich immunoassay. Both use a labeled antibody for the quantitative measurement of bone ALP in human serum. The OPUS Bone ALP and the Hybritech Tandem-R Ostase are based on a six level calibrator system. The OPUS Bone ALP differs from the Hybritech Tandem-R Ostase in that the mouse monoclonal antibody is labeled with $^{125}$I in the Hybritech Tandem-R Ostase, while the enzyme labeled antibody is a mouse monoclonal in the OPUS Bone ALP test. Also, the OPUS Bone ALP includes a tri-level control, where as the Hybritech Tandem-R Ostase test includes a bi-level control. Additionally, the OPUS Bone ALP is used with a fully automated fluorometric instrument system, while the Hybritech Tandem-R Ostase uses a gamma counter. ## 7. Proposed Device Performance Characteristics: ### Precision Intra-assay precision was determined by the evaluation of three levels of control material in replicates of twenty (20) each. %CV ranged from 2.7% to 5.23%. Inter-assay precision was determined by the evaluation of three levels of control material in duplicate, assayed over a five day period to total 20 replicates. %CV ranged from 4.57% to 7.06%. ### Accuracy by Recovery Recovery was determined by making four dilutions of an elevated Bone AP patient sample into a normal human serum pool. The samples were assayed using OPUS Bone ALP in duplicate. Percent recovery ranged from 98% to 103%. ### Accuracy by Correlation OPUS Bone ALP was compared to a commercially available immunoassay by evaluation of 50 serum samples ranging from 5.83 to 115 ng/ml. A correlation coefficient of 0.992 was obtained with a y-intercept value of 0.77 and a slope of 1.06. 000313 CONFIDENTIAL --- **Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CIN/K964764](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/CIN/K964764) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com