(27 days)
No
The device description and performance studies focus on the chemical composition and precision of quality control materials for an immunoassay, with no mention of AI or ML.
No.
The device is described as quality control material used to monitor the precision and accuracy of an assay, not for treating any medical condition.
No
This device is described as quality control material to monitor the precision and accuracy of an assay, not for diagnosing a patient's condition.
No
The device description clearly states it is a liquid control material containing processed human serum and preservatives, indicating it 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 T3 assay." This is a classic function of an IVD control material, used to ensure the reliability of a diagnostic test performed in vitro (outside the body).
- Device Description: The description details the composition of the controls ("liquid controls containing known levels of T3 in processed human serum"). This material is designed to be used in a laboratory setting with a specific assay.
- Performance Studies: The document includes a "Summary of Performance Studies" detailing precision evaluations. This type of testing is standard for IVD devices to demonstrate their performance characteristics.
- Predicate Device: The mention of a "Predicate Device(s)" (OPUS hCG Controls) is common in regulatory submissions for IVDs, indicating a comparison to a previously cleared device of a similar type.
While the document doesn't mention image processing, AI, or anatomical sites, these are not requirements for a device to be classified as an IVD. The core function of being used in vitro to provide information about a biological sample for diagnostic purposes is the key.
N/A
Intended Use / Indications for Use
The OPUS T3 Controls are intended for use as quality control material to monitor the precision and accuracy of the OPUS T3 assay.
Product codes
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Device Description
The OPUS T3 Controls are liquid controls containing known levels of T3 in processed human serum with anti-microbial agents and sodium azide as preservatives. The control is provided at three levels (low, mid and high). The OPUS T3 control is only for use with the OPUS T3 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
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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
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Summary of Performance Studies
Precision of the OPUS T3 Controls was evaluated on an OPUS Immunoassay System. intra assay precision was evaluated by running an n=20 with each level of the OPUS controls. %CV's ranged from 7.1 to 12.8 %.
The inter assay precision was evaluated by running duplicate determinations for each level of control twice per day (AM and PM) for five days to total an n=20. %CV's ranged from 13.1% to 17.9%.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
OPUS hCG Controls
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.
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K96 1206
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APR 2 3 1996
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510(k) Summary of Safety and Effectiveness for OPUS T3 Controls
Manufacturer Name, Address, phone number, contact name and date 1. of preparation:
Manufacturer: Behring Diagnostics Inc., 151 University Avenue Westwood. MA 02090 617-320-3153 Contact name: Nancy M Johansen
date of preparation: March 26, 1996
2. Device Name/Classification:
Quality Control Material (assayed)/Class 1 (862.1660)
Identification of the legally marketed device to which the submitter 3. claims equivalence.
OPUS hCG Controls
2. Proposed Device Description:
The OPUS T3 Controls are liquid controls containing known levels of T3 in processed human serum with anti-microbial agents and sodium azide as preservatives. The control is provided at three levels (low, mid and high). The OPUS T3 control is only for use with the OPUS T3 assay and has not been evaluated for use with other assays.
Proposed Device Intended Use: 3.
The OPUS T3 Controls are intended for use as quality control material to monitor the precision and accuracy of the OPUS T3 assay.
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Medical device to which equivalence is claimed and 4. comparison information:
The OPUS T3 Controls are substantially equivalent in intended use to the OPUS HOG Controls. Both products are in vitro diagnostic reagents intended for use as a quality control material to monitor specific laboratory procedures. The OPUS T3 Controls like the OPUS hQG Controls are liquid tri-level human serum based matrix controls. Both controls are provided with lot specific values and are for use with the OPUS assays onlv.
The OPUS T3 Controls differ from the OPUS hCG Controls in that the OPUS T3 Controls are for use with the OPUS T3 assay and contain known levels of T3 while the OPUS hCG Controls are for use with the OPUS hCG assay and contain known levels of hCG.
Proposed Device Performance Characteristics: 5.
Precision of the OPUS T3 Controls was evaluated on an OPUS Immunoassay System. intra assay precision was evaluated by running an n=20 with each level of the OPUS controls. %CV's ranged from 7.1 to 12.8 %.
The inter assay precision was evaluated by running duplicate determinations for each level of control twice per day (AM and PM) for five days to total an n=20. %CV's ranged from 13.1% to 17.9%.