(70 days)
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No
The summary describes a quantitative in vitro diagnostic assay using a specific immunoassay technology (EMIT) on a laboratory system. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The performance studies focus on correlation with a predicate device, which is standard for this type of assay.
No
The device measures drug levels, which are used to monitor therapy or diagnose overdose, but the device itself does not provide therapy.
Yes
The device is described as an "in vitro method" that quantitatively measures a drug in human serum or plasma to "diagnose and treat quinidine overdose" and "monitor serum levels...to ensure appropriate therapy." These applications directly relate to diagnostic purposes.
No
The device is an in vitro diagnostic assay that measures a drug in biological samples using a specific instrument (Technicon Immuno-10 system). This involves chemical reagents and hardware, not just software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that this is an "in vitro method" intended to measure a substance (Quiniciding drug) in human serum or plasma. This is a key characteristic of an IVD, as it involves testing samples taken from the body outside of the body itself.
- Purpose: The intended use also describes how the measurements are used: "in the diagnosis and treatment of quinidine overdose and in monitoring serum levels of quinidine to ensure appropriate therapy." This clearly indicates a medical purpose related to diagnosis and treatment, which is the core function of an IVD.
- Sample Type: The device analyzes "human serum or plasma," which are biological samples commonly used in IVD testing.
- Method: It uses the "Syva EMIT® 2000 Assay," which is a type of immunoassay, a common technique used in IVD testing.
The information provided strongly aligns with the definition and purpose of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
This in vitro method is intended to quantitatively measure Quiniciding drug, in human serum or plasma (heparin) using Syva EMIT® 2000 Assay on a Technicon Immuno-10 system. Measurements of quinidine are used in the diagnosis and treatment of quinidine overdose and in monitoring serum levels of quinidine to ensure appropriate therapy.
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
Listed below is a comparison of the performance between the Immuno 1 Quinidine method and a similar device that was granted clearance of substantial equivalence (Syva EMTT® 2000 Quindine Assay, Behring Diagnostics Inc.). The information used in the Summary of Safety and Effectiveness was extracted from the Immuno 1 Quinidine method sheet and the Syva EMIT® 2000 Quinidine Assay insert.
Key results:
- Minimum Detectable Conc. for Immuno 1 Quinidine: 0.06 µg/mL
- Minimum Detectable Conc. for Syva EMIT® 2000: 0.25 µg/mL
- Precision (Between-Run) for Immuno 1 Quinidine: 1.2 µg/mL 5.5%, 3.5 µg/mL 4.8%, 6.0 µg/mL 5.3%
- Precision (Between-Run) for Syva EMIT® 2000: 1.5 µg/mL 6.5%, 3.4 µg/mL 5.2%, 5.7 µg/mL 5.6%
- Correlation: y = 1.02x - 0.16 where y = Immuno 1 Quinidine method, x = Syva EMIT® 2000 Quinidine Assay. n = 25, r=0.991, Syx =0.148 µg/mL. This assay was performed on Roche COBAS FARA II® Instrument. Additional # patients requested, DATA provided in 11/26/96 memo. No significant Change in Correlation.
Key Metrics
Minimum Detectable Conc.
Precision (Between-Run)
Correlation (r, Syx)
Predicate Device(s)
Syva EMTT® 2000 Quindine Assay
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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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
DEC 24 1998
SUMMARY OF SAFETY AND EFFECTIVENESS
Quinidine Method for Bayer Technicon Immuno 1 System
Listed below is a comparison of the performance between the Immuno 1 Quinidine method and a similar device that was granted clearance of substantial equivalence (Syva EMTT® 2000 Quindine Assay, Behring Diagnostics Inc.). The information used in the Summary of Safety and Effectiveness was extracted from the Immuno 1 Quinidine method sheet and the Syva EMIT® 2000 Quinidine Assay insert.
INTENDED USED
This in vitro method is intended to quantitatively measure Quiniciding drug, in human serum or plasma (heparin) using Syva EMIT® 2000 Assay on a Technicon Immuno-10 system. Measurements of quinidine are used in the diagnosis and treatment of quinidine overdose and in monitoring serum levels of quinidine to ensure appropriate therapy.
| METHOD | | Immuno 1 Quinidine | Syva EMIT® 2000
(predicate Device) | |
|--------------------------|---|---------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------|--------------------|
| Part No. | | Reagents T01-3678-51
Calibrators T03-3680-01 | Reagents
Calibrators | 4Q019UL
4Q109UL |
| Minimum Detectable Conc. | | 0.06 µg/mL | | 0.25 µg/mL |
| Precision (Between-Run) | | 1.2 µg/mL 5.5%
3.5 µg/mL `4.8%
6.0 µg/mL 5.3% | 1.5 µg/mL 6.5%
3.4 µg/mL 5.2%
5.7 µg/mL 5.6% | |
| Correlation | * | y = 1.02x - 0.16
where
y = Immuno 1 Quinidine method
x = Syva EMIT® 2000 Quinidine Assay*
n = 25
r=0.991
Syx =0.148 µg/mL | | |
*This assay was performed on Roche COBAS FARA II® Instrument.
Gabriel J. Menaca, Jr.
Gabriel J. Muraca, Jr. Manager Regulatory Affairs Bayer Corporation 511 Benedict Avenue Tarrytown, New York 10591-5097
10/11/96
Date
- Please Note: Additional # patients requested, DATA provided in 11/26/96 memo. No significant Change in Correlatioい。 R013.