(58 days)
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No
The summary describes a standard immunoassay kit and analyzer for measuring a specific biomarker. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML applications in medical devices. The performance studies focus on traditional analytical metrics like precision and accuracy by recovery/correlation.
No
This device is an in vitro diagnostic immunoassay used for the quantitative measurement of bone alkaline phosphatase (bone ALP) in human serum, which aids in the management of patients with diagnosed Paget's disease. It is not used to treat or cure a disease.
Yes
The device is described as 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." This indicates its use in assessing a patient's condition to aid in their management, which is a diagnostic purpose.
No
The device is described as a set of reagents intended for use with immunoassay analyzers, indicating it is a chemical/biological reagent kit, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The description explicitly states "OPUS Bone ALP is an in vitro fluorogenic enzyme immunoassay (ELISA) for the quantitative measurement of bone alkaline phosphatase (bone ALP) in human serum..." The term "in vitro" is a key indicator of an IVD.
- Device Description: The description further clarifies that it's 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." This describes a system used to analyze biological samples outside of the body.
- Purpose: The purpose is to measure a substance (bone ALP) in a human sample (serum) to aid in the management of a disease (Paget's disease). This is a typical function of an IVD.
Therefore, based on the provided information, the OPUS Bone ALP device clearly fits the definition of an In Vitro Diagnostic.
N/A
Intended Use / 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.
Product codes
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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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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%.
Recovery Accuracy by
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 v-intercept value of 0.77 and a slope of 1.06.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Hybritech Tandem-R Ostase
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 862.1050 Alkaline phosphatase or isoenzymes test system.
(a)
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.(b)
Classification. Class II.
0
Behring Diagnostics Inc. OPUS® Bone ALP 510(k) Notification
JAN 24 1997 510(k) Summary for OPUS Bone ALP
Manufactures Name, Address, Telephone, and contact person, date of 1 . preparation:
Manufacturer:
Behring Diagnostics Inc. 151 University Avenue Westwood, MA 02090 617-320-3117 Attn: Ruth Forstadt
Preparation date:
November 26, 1996
Classification: 2 . Device Name/
OPUS Bone ALP: Classification Number: Alkaline Phosphatase or Isoenzmes Test System Class II (862.1050)
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. . .
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3. Identification of the legally marketed device:
Hybritech Tandem-R Ostase
Proposed Device Description: 4 .
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.
CONFIDENTIAL
1
Medical device to which equivalence is claimed and comparison 6. 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 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.
Proposed Device Performance Characteristics: 7 .
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%.
Recovery Accuracy by
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 v-intercept value of 0.77 and a slope of 1.06.
000013
CONFIDENTIAL