(59 days)
Not Known
Not Found
No
The description details a standard competitive immunoassay based on chemical reactions and light detection, with no mention of AI or ML algorithms for data analysis or interpretation.
No
This device is for the quantitative determination of free thyroxine (FT4) in serum, which is a diagnostic function, not a therapeutic one. It measures a substance to help understand a medical condition, rather than treating it.
Yes
The device is described as an immunoassay for the quantitative determination of free thyroxine (FT4) in serum, which is generally used to aid in the diagnosis of thyroid disorders. The "Intended Use / Indications for Use" directly states its purpose for quantitative determination in serum.
No
The device description clearly indicates it is an immunoassay that uses chemical reagents (acridinium ester, polyclonal rabbit anti-T4 antibody) and paramagnetic particles, which are physical components, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states "For the quantitative determination of free thyroxine (FT4) in serum". This indicates the device is used to analyze a sample taken from the human body (serum) to provide information about a physiological state (FT4 levels).
- Device Description: The description details a "competitive immunoassay" that uses "serum" as the sample. This is a common method used in IVD devices to measure substances in biological fluids.
- Performance Studies: The inclusion of performance studies like Accuracy and Precision, and metrics like Sensitivity, are typical for IVD devices to demonstrate their analytical performance.
- Predicate Device: The mention of a "Predicate Device" (Amerlex-MAB FT4) is a strong indicator that this device is being compared to an existing, legally marketed IVD device for regulatory purposes.
All these elements align with the definition and characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
For the quantitative determination of free thyroxine (FT4) in serum using the Ciba Corning Automated Chemiluminescence Systems.
Product codes
Not Found
Device Description
The Ciba Corning ASC FrT4 Immunoassay is a competitive immunoassay. FT4 in the-sample competes with the acridinium ester (AE-labeled T4 (Lite Reagent) for a limited amount of polyclonal rabbit anti-T4 antibody, which is covalently coupled to paramagnetic particles (solid phase). An indirect relationship exists between the FT4 in a sample and the relative light units (RLUs) detected.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Sensitivity:
The ACS FrT4 immunoassay measures FT4 concentrations up to 11.0 ng/dl with a minimum detectable concentration of 0.1 ng/dl.
Accuracy:
For 74 samples in the range of 0.62 to 4.26 ng/dl, the correlation between the ACS FrT4 immunoassay and the RIA reference method assay is described by the equation:
ACS FrT4 = 1.06 (RIA) - 0.33
Correlation coefficient (r) = 0.97
Precision:
Total precision (Total % CV) ranged form 2.81 to 4.65.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Sensitivity: minimum detectable concentration of 0.1 ng/dl.
Accuracy: Correlation coefficient (r) = 0.97
Precision: Total % CV ranged from 2.81 to 4.65.
Predicate Device(s)
Not Known
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.
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JUN 17 1996
Summary of Safety and Effectiveness
As required by 21 CFR 807.92, the following 510(k) Summary is provided:
1. Submitter Information
Contact person:
Thomas F. Flynn
Address:
Ciba Corning Diagnostics Corp. 63 North Street Medfield, MA 02052
508 359-3877 Phone: thomas.flynn@cibadiag.com e-mail:
Date Summary Prepared: April 19. 1996
2. Device Information
Proprietary Name: Common Name: Classification Name: ACS FrT4 Immunoassay FrT4 Immunoassay Class II, Free Thyroxine Test Kit. 21 CFR 862.1695
28342
3. Predicate Device Information
| Name: | Amerlex-MAB FT4 |
|---|---|
| Manufacturer: | Amerlex |
| 510(k) Number: | Not Known |
4. Device Description
The Ciba Corning ASC FrT4 Immunoassay is a competitive immunoassay. FT4 in the-sample competes with the acridinium ester (AE-labeled T4 (Lite Reagent) for a limited amount of polyclonal rabbit anti-T4 antibody, which is covalently coupled to paramagnetic particles (solid phase). An indirect relationship exists between the FT4 in a sample and the relative light units (RLUs) detected.
5. Statement of Intended Use
For the quantitative determination of free thyroxine (FT4) in serum using the Ciba Corning Automated Chemiluminescence Systems.
6. Summary of Technological Characteristics
The Ciba Corning ACS FrT4 procedure is a competitive chemiluminescence immunoassay.
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7. Performance Data
Sensitivity
The ACS FrT4 immunoassay measures FT4 concentrations up to 11.0 ng/dl with a minimum detectable concentration of 0.1 ng/dl.
Accuracy
For 74 samples in the range of 0.62 to 4.26 ng/dl, the correlation between the ACS FrT4 immunoassay and the RIA reference method assay is described by the equation:
ACS FrT4 = 1.06 (RIA) - 0.33
Correlation coefficient (r) = 0.97
Precision
Total precision (Total % CV) ranged form 2.81 to 4.65.
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