(51 days)
Not Found
No
The device description details a standard enzymatic immunoassay for quantitative determination of primidone. There is no mention of AI or ML in the intended use, device description, or performance studies.
No.
The document indicates that the device is a reagent for determining primidone levels in serum, which is used to aid in adjusting patient dosage of an anticonvulsant. It is a diagnostic tool, not a therapeutic device.
No
This device is a reagent used for the quantitative determination of primidone in human serum, which aids in monitoring drug levels. While this information can be used by physicians to adjust patient dosage, the device itself performs the measurement, not the diagnosis of a condition.
No
The device description clearly outlines a chemical reagent kit used with a clinical chemistry analyzer, which are physical components, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the ACE® Primidone Reagent is for the "quantitative determination of primidone in human serum." This is a classic example of an in vitro diagnostic test, as it analyzes a biological sample (serum) outside of the body to provide information about a patient's health status (primidone levels).
- Device Description: The description details a chemical assay that uses reagents to measure a substance in a sample. This is consistent with the nature of IVD devices.
- Performance Studies: The document includes performance studies like precision and correlation studies, which are standard for demonstrating the analytical performance of an IVD.
- Predicate Device: The mention of a predicate device (K960526; Diagnostic Reagents, Inc. (DRI) - Primidone Reagent) further confirms its classification as an IVD, as predicate devices are used for comparison in the regulatory submission process for new IVDs.
The information provided aligns perfectly with the definition and characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
ACE® Primidone Reagent is intended for use in the quantitative determination of primidone in human serum.
ACE® Primidone Reagent is intended for the quantitative determination of primidone in serum using the ACE® clinical chemistry analyzer.
Primidone (Mysoline®) used alone, or in combination with other anticonvulsants, is indicated in the control of grand mal, psychomotor, and focal epileptic seizures. In combination with other clinical data, monitoring serum primidone levels will provide physicians with useful information to aid in adjusting patient dosage to achieve optimal therapeutic effect while avoiding drug toxicity.
Product codes
DJD
Device Description
The ACE® Primidone Reagent contains two reagents, an Antibody/Substrate reagent and an Enzyme Conjugate reagent. The assay uses specific antibodies to primidone and is based on the competition of an enzyme glucose-6-phosphate dehydrogenase (G6PDH) labeled drug and the free drug from the sample, for a fixed amount of specific antibody binding sites. In the absence of free drug from the sample, the drug-labeled G6PDH is bound by the specific antibody and the enzyme activity is inhibited. This phenomenon creates a relationship between drug concentration in the sample and the enzyme activity. The enzyme G6PDH activity is determined bichromatically on the ACE® at 340/505 nm by measuring its ability to convert NAD* to NADH.
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
Non-clinical test results submitted in the premarket notification include within-run and between-run er in the submitted in the first in a dote summary Non-cinlical test resures submitted in the proving is a data summary.
Assay Range: 0.3 µg/mL to 24 µg/mL
Precision:
Within Run:
§ 862.3680 Primidone test system.
(a)
Identification. A primidone test system is a device intended to measure primidone, an antiepileptic drug, in human specimens. Measurements obtained by this device are used in the diagnosis and treatment of primidone overdose and in monitoring levels of primidone to ensure appropriate therapy.(b)
Classification. Class II.
0
NOT : 1997
- Jec
510(k) PREMARKET NOTIFICATION ACE® Primidone Reagent
SUMMARY OF SAFETY AND EFFECTIVENESS
In lieu of a 510(k) statement under 513(i) of the Act, this Summary of Safety and Effectiveness is provided as a 510(k) summary for disclosure to any other persons/companies without specific written authorization from Schiapparelli Biosystems, Inc.
Submitter
Schiapparelli Biosystems, Inc. 368 Passaic Avenue Fairfield, NJ 07004 Phone: (973) 882-8630
Contact Person
Steven Dalessio Manager, Quality Assurance/Regulatory Affairs Phone: (973) 882-8630
Device Names
| Proprietary Name: | ACE® Primidone Reagent |
|---|---|
| Common Name: | Enzyme immunoassay for primidone |
| Classification Name: | Primidone test |
| Predicate Device: | Diagnostic Reagents, Inc. (DRI) - Primidone Reagent [510(k) Number |
| K960526] |
Device Description
The ACE® Primidone Reagent contains two reagents, an Antibody/Substrate reagent and an Enzyme Conjugate reagent. The assay uses specific antibodies to primidone and is based on the competition of an enzyme glucose-6-phosphate dehydrogenase (G6PDH) labeled drug and the free drug from the sample, for a fixed amount of specific antibody binding sites. In the absence of free drug from the sample, the drug-labeled G6PDH is bound by the specific antibody and the enzyme activity is inhibited. This phenomenon creates a relationship between drug concentration in the sample and the enzyme activity. The enzyme G6PDH activity is determined bichromatically on the ACE® at 340/505 nm by measuring its ability to convert NAD* to NADH.
Intended Use of the Device
ACE® Primidone Reagent is intended for use in the quantitative determination of primidone in human serum.
1
510(k) PREMARKET NOTIFICATION ACE® Primidone Reagent
0
1
SUMMARY OF SAFETY AND EFFECTIVENESS
COMPARATIVE FEATURES OF PREDICATE AND PROPOSED DEVICES
| PARAMETER | PREDICATE DEVICE | PROPOSED DEVICE |
|---|---|---|
| Trade Name | DRI Primidone Enzyme | |
| Immunoassay | ACE® Primidone Reagent | |
| Reference No. | K960526 | TBD |
| Analyte | Primidone | Primidone |
| Intended Use | Quantitative determination of | |
| primidone | Quantitative determination of | |
| primidone | ||
| Methodology | Enzyme immunoassay | Enzyme immunoassay |
| Reagents | ||
| Reagent 1 | ||
| Volume | Liquid; Antibody/Substrate | |
| 210 µL | Liquid; Antibody/Substrate | |
| 210 µL | ||
| Reagent 2 | ||
| Volume | Liquid; Enzyme conjugate | |
| 70 µL | Liquid; Enzyme conjugate | |
| 70 µL | ||
| Specimen | ||
| Type | ||
| Volume | Serum and plasma | |
| 5 µL | Serum | |
| 3 µL | ||
| Assay System | ||
| Reagent 1 + Sample | ||
| Reagent 2 | ||
| Temperature | Incubate 300 sec | |
| Read 60 and 120 sec | ||
| 37 °C | Incubate 240 sec | |
| Read 63 and 273 sec | ||
| 37 °C | ||
| Detection Method | ||
| Type | ||
| Wavelength, nm | Spectrophotometric | |
| Bichromatic: 340/505 | Spectrophotometric | |
| Bichromatic: 340/505 |
2
510(k) PREMARKET NOTIFICATION ACE® Primidone Reagent
SUMMARY OF SAFETY AND EFFECTIVENESS
PERFORMANCE ASSESSMENT
Non-clinical test results submitted in the premarket notification include within-run and between-run
er in the submitted in the first in a dote summary Non-cinlical test resures submitted in the proving is a data summary.
| PARAMETER | PREDICATE DEVICE | PROPOSED DEVICE |
|---|---|---|
| Performance Summary | ||
| Assay Range | 0.5 µg/mL to 24 µg/mL | 0.3 µg/mL to 24 µg/mL |
| Precision | ||
| Within Run |