(32 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 technologies. The performance studies focus on traditional analytical metrics like precision and correlation.
No
This device is a reagent for in vitro diagnostic use, intended for quantitative determination of carbamazepine in human serum, not for treating or diagnosing a disease.
Yes
The device "ACE® Carbamazepine Reagent" is intended for the quantitative determination of carbamazepine in human serum, which provides information for diagnosis, treatment, or prevention of disease.
No
The device description clearly outlines a reagent kit containing chemical components (Antibody/Substrate reagent and Enzyme Conjugate reagent) used in a chemical reaction on a clinical chemistry analyzer. This is a hardware/chemical-based diagnostic test, 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 carbamazepine 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 (carbamazepine levels).
- Device Description: The description details a chemical assay that uses reagents to measure a substance in a biological sample. This is the fundamental principle of many IVD devices.
- Performance Studies: The summary of performance studies describes analytical performance characteristics like precision and correlation, which are typical evaluations for IVD devices to demonstrate their accuracy and reliability.
- Predicate Device: The mention of a predicate device (K955100; Diagnostic Reagents, Inc. (DRI) - Carbamazepine Reagent) further confirms its classification as an IVD, as predicate devices are used for comparison in the regulatory submission process for new IVDs.
Therefore, based on the provided information, the ACE® Carbamazepine Reagent clearly fits the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
ACE® Carbamazepine Reagent is intended for use in the quantitative determination of carbamazepine in human serum.
ACE® Carbamazepine Reagent is intended for the quantitative determination of carbamazepine in serum using the ACE® clinical chemistry analyzer.
Product codes
KLT, DKB
Device Description
The ACE® Carbamazepine Reagent contains two reagents, an Antibody/Substrate reagent and an Enzyme Conjugate reagent. The assay uses specific antibodies to carbamazepine 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
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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: 0.3 µg/mL to 20 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
OCT 20 1997
510(k) PREMARKET NOTIFICATION ACE® Carbamazepine 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® Carbamazepine Reagent |
|---|---|
| Common Name: | Enzyme immunoassay for carbamazepine (Tegretol®) |
| Classification Name: | Carbamazepine test |
| Predicate Device: | Diagnostic Reagents, Inc. (DRI) - Carbamazepine Reagent [510(k) |
| Number K955100] |
Device Description
The ACE® Carbamazepine Reagent contains two reagents, an Antibody/Substrate reagent and an Enzyme Conjugate reagent. The assay uses specific antibodies to carbamazepine 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® Carbamazepine Reagent is intended for use in the quantitative determination of carbamazepine in human serum.
1
510(k) PREMARKET NOTIFICATION ACE® Carbamazepine Reagent
SUMMARY OF SAFETY AND EFFECTIVENESS
COMPARATIVE FEATURES OF PREDICATE AND PROPOSED DEVICES
| PARAMETER | PREDICATE DEVICE | PROPOSED DEVICE |
|---|---|---|
| Trade Name | DRI Carbamazepine Enzyme | |
| Immunoassay | ACE® Carbamazepine Reagent | |
| Reference No. | K955100 | TBD |
| Analyte | Carbamazepine | Carbamazepine |
| Intended Use | Quantitative determination of | |
| carbamazepine | Quantitative determination of | |
| carbamazepine | ||
| 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® Carbamazepine 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 | 0.5 µg/mL to 20 µg/mL | |
| ✓ | OR | Over-The-Counter Use ______ |
| ---------------------- | -------------------------------------------- | ---- |
| (Per 21 CFR 801.109) |