(24 days)
Not Found
Not Found
No
The document describes quality control materials for an immunoassay, focusing on precision and accuracy testing. There is no mention of AI or ML in the intended use, device description, or performance studies.
No
The device is described as quality control material for monitoring the precision and accuracy of an assay, not for treating any medical condition.
No
The device is described as "quality control material to monitor the precision and accuracy of the OPUS Myoglobin assay," not as a device intended for diagnosing a disease or condition in a patient.
No
The device description clearly states it is a lyophilized control material containing human myoglobin in processed human serum, which is a physical substance, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the controls are "intended for use as quality control material to monitor the precision and accuracy of the OPUS Myoglobin assay." This indicates that the device is used in vitro (outside the body) to assess the performance of a diagnostic test.
- Device Description: The description mentions that the controls contain "human myoglobin in processed human serum." This is a biological sample used in vitro for testing purposes.
- Purpose: Quality control materials are a fundamental part of in vitro diagnostic testing to ensure the reliability and accuracy of the results.
While the document doesn't explicitly use the term "In Vitro Diagnostic" in the intended use, the function and nature of the device clearly align with the definition of an IVD.
N/A
Intended Use / Indications for Use
The OPUS Myoglobin Controls are intended for use as quality control material to monitor the precision and accuracy of the OPUS Mvoqlobin assay.
Product codes
Not Found
Device Description
The OPUS Myoglobin Controls are lyophilized controls containing known levels of human myoglobin in processed human serum. The control is provided at three levels (low, mid and high). The OPUS Myoglobin Control is only for use with the OPUS Myoglobin assay and has not been evaluated for use with other assays.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Precision of the OPUS Myoglobin Controls was evaluated on an OPUS Immunoassay System with the OPUS Myoglobin assay. Intra assay precision was evaluated by running an n=20 with each level of the OPUS control. %CV's ranged from 4.27% to 6.05% for myoglobin. The inter assay precision was evaluated by running duplicate determinations for each level of control twice over a 15 day period to total an n=8. %CV's ranged from 6.55% to 10.54% for myoglobin.
Key Metrics
%CV's ranged from 4.27% to 6.05% for myoglobin (intra assay). %CV's ranged from 6.55% to 10.54% for myoglobin (inter assay).
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 862.1660 Quality control material (assayed and unassayed).
(a)
Identification. A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.(b)
Classification. Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
0
..
510(k) Summary of Safety and Effectiveness for OPUS Myoglobin Controls
AUG 15 1996
Manufacturer Name, Address, phone number, contact 1. name and date of preparation.
Behring Diagnostics, Inc. Manufacturer: 151 University Avenue Westwood, MA 02090 617-320-3117 Contact name: Ruth C. Forstadt
Date of preparation: July 17, 1996
Name/Classification: 2. Device
OPUS Myoglobin Controls: Quality Control material (assayed)
Class 1 (862.1660) Classification number:
Identification of the legally marketed device to which 3. the submitter claims equivalence.
OPUS hCG Controls
Proposed Device Description: 4 .
The OPUS Myoglobin Controls are lyophilized controls containing known levels of human myoglobin in processed human serum. The control is provided at three levels (low, mid and high). The OPUS Myoglobin Control is only for use with the OPUS Myoglobin assay and has not been evaluated for use with other assays.
1
Proposed Device Intended Use: 5.
The OPUS Myoglobin Controls are intended for use as quality control material to monitor the precision and accuracy of the OPUS Mvoqlobin assay.
Medical device to which equivalence is claimed and 6. comparison information:
The OPUS Myoglobin Controls are substantially equivalent in intended use to the OPUS hCG Controls. Both products are in vitro diagnostic reagents intended for use as a quality control material to monitor specific laboratory procedures. The OPUS Myoglobin Controls, like the OPUS hCG Controls, are a tri-level serum-based matrix control for specific OPUS assays. Both controls are provided with lot specific values and are for use with the OPUS assays only.
The OPUS Myoglobin Controls differ from the OPUS hCG Controls in that the OPUS Myoglobin Controls are for use with the OPUS Myoglobin assay and contain known levels of myoglobin, while the OPUS hCG Controls are for use with the the OPUS hCG assay and contain known levels of hCG. Also, the OPUS Myoglobin control is provided as a lyophilized control while the OPUS hCG controls are provided in a liquid form.
Proposed Device Performance Characteristics: 7.
Precision of the OPUS Myoglobin Controls was evaluated on an OPUS Immunoassay System with the OPUS Myoglobin assay. Intra assay precision was evaluated by running an n=20 with each level of the OPUS control. %CV's ranged from 4.27% to 6.05% for myoglobin.
The inter assay precision was evaluated by running duplicate determinations for each level of control twice over a 15 day period to total an n=8. %CV's ranged from 6.55% to 10.54% for myoglobin.