(49 days)
Not Found
No
The device description details a standard immunoassay based on enzyme activity and spectrophotometry, with no mention of AI or ML algorithms for data analysis or interpretation.
No
The device is a reagent for determining the quantitative level of a drug in human serum, rather than directly treating a condition or affecting the body's structure or function.
Yes
The ACE® Phenobarbital Reagent is used for the "quantitative determination of phenobarbital in human serum", which provides information about the state of the patient's health by measuring drug levels. This information is typically used in the diagnosis, treatment, or prevention of disease.
No
The device is a reagent kit, which is a chemical substance used in a laboratory test. It is not a software-only medical device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "quantitative determination of phenobarbital in human serum." This involves testing a sample taken from the human body (serum) outside of the body (in vitro) to diagnose or monitor a condition (in this case, likely related to phenobarbital levels for therapeutic drug monitoring or toxicology).
- Device Description: The description details a chemical assay that uses reagents to measure a substance in a biological sample. This is a hallmark of in vitro diagnostics.
- Predicate Device: The mention of a predicate device (K946210; Diagnostic Reagents, Inc. (DRI) - Phenobarbital Reagent) which is also a reagent for phenobarbital determination, further supports its classification as an IVD. Predicate devices are typically other legally marketed IVDs.
The information provided clearly aligns with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
ACE® Phenobarbital Reagent is intended for use in the quantitative determination of phenobarbital in human serum.
ACE® Phenobarbital Reagent is intended for the quantitative determination of phenobarbital in serum using the ACE® clinical chemistry analyzer.
Since its discovery by Hauptmann in 1912, phenobarbital has been widely prescribed for the treatment of epilepsy, particularly for controlling focal motor or sensory and grand mal seizures. In combination with other clinical information, monitoring serum phenobarbital levels will provide physicians with an essential tool to aid in adjusting dosage and achieving optimal therapeutic effect, while avoiding both subtherapeutic and harmful toxic drug levels.
Product codes (comma separated list FDA assigned to the subject device)
DLJ
Device Description
The ACE® Phenobarbital Reagent contains two reagents, an Antibody/Substrate reagent and an Enzyme Conjugate reagent. The assay uses specific antibodies to phenobarbital 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: 1.3 µg/mL to 80 µg/mL
Precision:
Within Run:
§ 862.3200 Clinical toxicology calibrator.
(a)
Identification. A clinical toxicology calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. A clinical toxicology calibrator can be a mixture of drugs or a specific material for a particular drug (e.g., ethanol, lidocaine, etc.). (See also § 862.2 in this part.)(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
0
17413336
510(k) PREMARKET NOTIFICATION ACE® Phenobarbital Reagent
NOV - 6 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® Phenobarbital Reagent |
|---|---|
| Common Name: | Enzyme immunoassay for phenobarbital |
| Classification Name: | Phenobarbital test |
| Predicate Device: | Diagnostic Reagents, Inc. (DRI) - Phenobarbital Reagent [510(k) Number |
| K946210] |
Device Description
The ACE® Phenobarbital Reagent contains two reagents, an Antibody/Substrate reagent and an Enzyme Conjugate reagent. The assay uses specific antibodies to phenobarbital 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® Phenobarbital Reagent is intended for use in the quantitative determination of phenobarbital in human serum.
1
510(k) PREMARKET NOTIFICATION ACE® Phenobarbital Reagent
SUMMARY OF SAFETY AND EFFECTIVENESS
COMPARATIVE FEATURES OF PREDICATE AND PROPOSED DEVICES
| PARAMETER | PREDICATE DEVICE | PROPOSED DEVICE |
|---|---|---|
| Trade Name | DRI Phenobarbital Enzyme | |
| Immunoassay | ACE® Phenobarbital Reagent | |
| Reference No. | K946210 | TBD |
| Analyte | Phenobarbital | Phenobarbital |
| Intended Use | Quantitative determination of | |
| phenobarbital | Quantitative determination of | |
| phenobarbital | ||
| 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® Phenobarbital 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 80 µg/mL |