(56 days)
No
The device description details a chemical assay based on enzyme activity and antibody binding, with no mention of AI or ML technologies. The performance studies focus on standard analytical chemistry metrics like precision and correlation.
No.
This device is an analytical reagent used for the quantitative determination of phenytoin in human serum, which is a diagnostic purpose, not a therapeutic one.
Yes
Explanation: The "Intended Use / Indications for Use" section states that the device is for the "quantitative determination of phenytoin in human serum," and phenytoin levels are measured to guide the treatment of epilepsy. This measurement is used to determine a patient's condition or disease or to determine the state of health, which falls under the definition of a diagnostic device.
No
The device description clearly states it is a reagent kit containing two reagents (Antibody/Substrate and Enzyme Conjugate) used with a clinical chemistry analyzer (ACE®). This indicates it is a chemical product and not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states "quantitative determination of phenytoin in human serum." This is a classic example of an in vitro diagnostic test, as it analyzes a sample (serum) taken from the human body outside of the body to provide information about a medical condition (phenytoin levels for epilepsy treatment).
- Device Description: The description details a chemical assay that uses reagents to measure a substance (phenytoin) in a biological sample (serum). This is the core function of an IVD.
- Performance Studies: The inclusion of performance studies like precision and method correlation against another device (Hitachi 717) is typical for IVD submissions to regulatory bodies.
- Predicate Device: The mention of a predicate device (K945725; Diagnostic Reagents, Inc. (DRI) - Phenytoin Reagent) which is also an IVD, further confirms the classification of this device.
The information provided clearly aligns with the definition and characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
ACE® Phenytoin Reagent is intended for use in the quantitative determination of phenytoin in human serum.
ACE® Phenytoin Reagent is intended for the quantitative determination of phenytoin in serum using the ACE® clinical chemistry analyzer.
Product codes
DIP
Device Description
The ACE® Phenytoin Reagent contains two reagents, an Antibody/Substrate reagent and an Enzyme Conjugate reagent. The assay uses specific antibodies to phenytoin and is based on the competition of an enzyme glucose-o-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 precision and method correlation.
Performance Summary
Assay Range: 0.6 µg/mL to 40 µg/mL
Precision:
Within Run:
§ 862.3350 Diphenylhydantoin test system.
(a)
Identification. A diphenylhydantoin test system is a device intended to measure diphenylhydantoin, an antiepileptic drug, in human specimens. Measurements obtained by this device are used in the diagnosis and treatment of diphenylhydantoin overdose and in monitoring levels of diphenylhydantoin to ensure appropriate therapy.(b)
Classification. Class II.
0
KA73414
ﻳﺮ ﺍﻟﻤﺴﺎﺣﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟ
510(k) PREMARKET NOTIFICATION ACE® Phenytoin Reagent
NOV - 4 1997
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® Phenytoin Reagent | ||
|---|---|---|---|
| Common Name: | Enzyme immunoassay for phenytoin (diphenylhydantoin or Dilantin®) | ||
| Classification Name: | Phenytoin test | ||
| Predicate Device: | Diagnostic Reagents, Inc. (DRI) - Phenytoin Reagent [510(k) Number | ||
| K945725] |
Device Description
The ACE® Phenytoin Reagent contains two reagents, an Antibody/Substrate reagent and an Enzyme Conjugate reagent. The assay uses specific antibodies to phenytoin and is based on the competition of an enzyme glucose-o-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® Phenytoin Reagent is intended for use in the quantitative determination of phenytoin in human serum.
1
510(k) PREMARKET NOTIFICATION ACE® Phenytoin Reagent
SUMMARY OF SAFETY AND EFFECTIVENESS
COMPARATIVE FEATURES OF PREDICATE AND PROPOSED DEVICES
| PARAMETER | PREDICATE DEVICE | PROPOSED DEVICE |
|---|---|---|
| Trade Name | DRI Phenytoin Enzyme | |
| Immunoassay | ACE® Phenytoin Reagent | |
| Reference No. | K945725/S1 | TBD |
| Analyte | Phenytoin | Phenytoin |
| Intended Use | Quantitative determination of | |
| phenytoin | Quatitative determination of | |
| phenytoin | ||
| 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 | |
| 5 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 203 sec | ||
| 37 °C | ||
| Detection Method | ||
| Type | ||
| Wavelength, nm | Spectrophotometric | |
| Bichromatic: 340/505 | Spectrophotometric | |
| Bichromatic: 340/505 |
2
510(k) PREMARKET NOTIFICATION ACE® Phenytoin Reagent
SUMMARY OF SAFETY AND EFFECTIVENESS
PERFORMANCE ASSESSMENT
Non-clinical test results submitted in the premarket notification include within-run and between-run precision and method correlation. Following is a data summary.
| PARAMETER | PREDICATE DEVICE | PROPOSED DEVICE |
|---|---|---|
| Performance Summary | ||
| Assay Range | ||
| Precision | ||
| Within Run | ||
| Between Run | 0.3 µg/mL to 40 µg/mL |