(120 days)
INNOFLUOR™ Quinidine Reagent Set (Existing), Abbott Quinidine Assay
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No
The document describes a quinidine assay system and its performance compared to existing methods, with no mention of AI or ML technologies.
No.
The device is described as an assay system for measuring quinidine concentrations, which is a diagnostic tool, not a therapeutic device.
Yes.
The device is an "Assay System" used to measure quinidine concentrations in patient samples, which is a diagnostic activity.
No
The 510(k) summary describes a "Quinidine Assay System" and "Quinidine Reagent Set," which are typically laboratory-based tests involving chemical reagents and potentially hardware analyzers (like the mentioned Abbott TDx® analyzer). There is no indication that the device is solely software.
Based on the provided text, the device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The text explicitly states the device is an "INNOFLUOR™ Quinidine Assay System". Assays are laboratory tests performed in vitro (outside the body) to measure substances in biological samples.
- Comparison to Existing IVDs: The document compares the device to the "INNOFLUOR™ Quinidine Reagent Set (Existing)" and the "Abbott Quinidine Assay". Both of these are clearly described as assays, which are a type of IVD.
- Sample Type: The performance study uses "serum patient samples". Analyzing biological samples like serum is a hallmark of IVD devices.
- Measurement of a Substance: The device measures "Quinidine concentrations". Measuring specific substances in biological samples is the core function of many IVDs.
Therefore, the description strongly indicates that the INNOFLUOR™ Quinidine Assay System (Modified) is an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
"Quinidine concentrations measured by the INNOFLUOR™ QUINIDINE Assay System (Modified), (INNOFLUOR™), on the Abbott TDx® analyzer"
Product codes
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Device Description
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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)
"Comparison of the patient sample results by linear regression analysis resulted in the regression equation: (INNOFLUOR™) = 0.958 x (Abbott) - 0.077, with a correlation coefficient of 0.986."
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
"correlation coefficient of 0.986"
Predicate Device(s)
INNOFLUOR™ Quinidine Reagent Set (Existing), Abbott Quinidine Assay
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc)
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§ 862.3320 Digoxin test system.
(a)
Identification. A digoxin test system is a device intended to measure digoxin, a cardiovascular drug, in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of digoxin overdose and in monitoring levels of digoxin to ensure appropriate therapy.(b)
Classification. Class II.
0
K9555608 4PR-4
SUMMARY OF SAFETY AND EFFECTIVENESS
Substantial equivalence has been demonstrated between the INNOFLUOR™ Quinidine Assay System (Modified) the INNOFLUOR™ Quinidine Reagent Set (Existing) and the Abbott Quinidine Assay.
The technological characteristics, performance and intended use of the INNOFLUOR™ Quinidine Assay System (Modified) are substantially equivalent to the INNOFLUOR™ Quinidine Reagent Set (Existing) and the Abbott Quinidine Assay.
Quinidine concentrations measured by the INNOFLUOR™ QUINIDINE Assay System (Modified), (INNOFLUOR™), on the Abbott TDx® analyzer were compared with those measured by the Abbott Quinidine Assay, (Abbott), on 49 serum patient samples. Comparison of the patient sample results by linear regression analysis resulted in the regression equation: (INNOFLUOR™) = 0.958 x (Abbott) - 0.077, with a correlation coefficient of 0.986.