(51 days)
Not Found
No
The device description details a chemical assay based on enzyme activity and antibody binding, with no mention of AI or ML algorithms for data analysis or interpretation. The performance studies focus on traditional analytical metrics like precision and correlation.
No
This device is a reagent intended for the quantitative determination of valproic acid in human serum, which is a diagnostic function, not a therapeutic one.
Yes
The device is intended for the quantitative determination of valproic acid in human serum, which is a measurement used to aid in diagnosis and monitoring of medical conditions.
No
The device is a reagent kit containing chemical components, not software. It is used with a separate analyzer.
Based on the provided information, yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states "quantitative determination of valproic acid 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 (valproic acid 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 summary of performance studies mentions "within-run and between-run precision and method correlation," which are standard performance characteristics evaluated for IVD devices.
- Predicate Device: The identification of a predicate device (K961988; Diagnostic Reagents, Inc. (DRI) - Valproic Acid Reagent) further confirms its classification as an IVD, as predicate devices are typically other legally marketed IVDs.
The fact that it does not mention image processing, AI/ML, specific anatomical sites, or patient age ranges does not preclude it from being an IVD. Many IVDs are chemical or biological assays that do not involve these aspects.
N/A
Intended Use / Indications for Use
ACE® Valproic Acid Reagent is intended for use in the quantitative determination of valproic acid in human serum.
ACE® Valproic Acid Reagent is intended for the quantitative determination of valproic acid in serum using the ACE® clinical chemistry analyzer.
Product codes (comma separated list FDA assigned to the subject device)
LEG
Device Description
The ACE® Valproic Acid Reagent contains two reagents, an Antibody/Substrate reagent and an Enzyme Conjugate reagent. The assay uses specific antibodies to valproic acid 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical test results submitted in the premarket notification include within-run and between-run precision and method correlation.
Performance Summary:
Assay Range: 3.1 µg/mL to 150 µg/mL
Precision: Within Run
§ 862.3645 Neuroleptic drugs radioreceptor assay test system.
(a)
Identification. A neuroleptic drugs radioceptor assay test system is a device intended to measure in serum or plasma the dopamine receptor blocking activity of neuroleptic drugs and their active metabolites. A neuroleptic drug has anti-psychotic action affecting principally psychomotor activity, is generally without hypnotic effects, and is a tranquilizer. Measurements obtained by this device are used to aid in determining whether a patient is taking the prescribed dosage level of such drugs.(b)
Classification. Class II.
0
1115581
510(k) PREMARKET NOTIFICATION ACE® Valproic Acid Reagent
NOV 1 2 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® Valproic Acid Reagent |
|---|---|
| Common Name: | Enzyme immunoassay for valproic acid |
| Classification Name: | Valproic Acid test |
| Predicate Device: | Diagnostic Reagents, Inc. (DRI) - Valproic Acid Reagent [510(k) Number |
| K961988] |
Device Description
The ACE® Valproic Acid Reagent contains two reagents, an Antibody/Substrate reagent and an Enzyme Conjugate reagent. The assay uses specific antibodies to valproic acid 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® Valproic Acid Reagent is intended for use in the quantitative determination of valproic acid in human serum.
1
510(k) PREMARKET NOTIFICATION ACE® Valproic Acid Reagent
SUMMARY OF SAFETY AND EFFECTIVENESS
COMPARATIVE FEATURES OF PREDICATE AND PROPOSED DEVICES
| PARAMETER | PREDICATE DEVICE | PROPOSED DEVICE |
|---|---|---|
| Trade Name | DRI Valproic Acid Enzyme | |
| Immunoassay | ACE® Valproic Acid Reagent | |
| Reference No. | K961988 | TBD |
| Analyte | Valproic Acid | Valproic Acid |
| Intended Use | Quantitative determination of | |
| valproic acid | Quantitative determination of | |
| valproic acid | ||
| 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 | |
| 15 µL | Serum | |
| 10 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® Valproic Acid 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 | 3 µg/mL to 150 µg/mL |