(51 days)
Not Found
No
The device description details a standard enzymatic immunoassay for measuring theophylline levels. There is no mention of AI or ML in the intended use, device description, or performance studies. The mechanism is based on chemical reactions and enzymatic activity, not data-driven algorithms.
No.
This device is a reagent used for the quantitative determination of theophylline in serum, which aids in monitoring drug levels for treatment, but it is not a therapeutic device itself.
Yes
Explanation: The device is intended for the quantitative determination of theophylline in serum, and monitoring these levels "may provide the physician with useful information to aid in adjusting patient dosage to achieve optimal therapeutic effect while avoiding drug toxicity." This clearly indicates its use in aiding diagnosis and treatment decisions.
No
The device description clearly states it is a reagent kit containing two physical reagents (Antibody/Substrate and Enzyme Conjugate) used in conjunction with a clinical chemistry analyzer. This indicates it is a physical chemical product, not software.
Based on the provided information, the ACE® Theophylline Reagent is indeed an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "quantitative determination of theophylline in serum." This involves testing a biological sample (serum) outside of the body to gain information about a patient's health status (theophylline levels).
- Device Description: The description details a chemical assay that uses reagents to measure a substance in a sample. This is a hallmark of an in vitro diagnostic test.
- Purpose: The purpose of monitoring theophylline levels is to "aid in adjusting patient dosage to achieve optimal therapeutic effect while avoiding drug toxicity." This directly relates to providing information for medical diagnosis, treatment, or prevention of disease.
Therefore, the ACE® Theophylline Reagent fits the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
ACE® Theophylline Reagent is intended for use in the quantitative determination of theophylline in human serum.
ACE® Theophylline Reagent is intended for the quantitative determination of theophylline in serum using the ACE® clinical chemistry analyzer.
Product codes (comma separated list FDA assigned to the subject device)
KIS
Device Description
The ACE® Theophylline Reagent contains two reagents, an Antibody/Substrate reagent and an Enzyme Conjugate reagent. The assay uses specific antibodies to theophylline 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.
Assay Range: 0.3 µg/mL to 40 µg/mL
Precision: Within Run
§ 862.3880 Theophylline test system.
(a)
Identification. A theophylline test system is a device intended to measure theophylline (a drug used for stimulation of the muscles in the cardiovascular, respiratory, and central nervous systems) in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of theophylline overdose or in monitoring levels of theophylline to ensure appropriate therapy.(b)
Classification. Class II.
0
1000
יור אי 10 007
510(k) PREMARKET NOTIFICATION ACE® Theophylline 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® Theophylline Reagent |
|---|---|
| Common Name: | Enzyme immunoassay for theophylline |
| Classification Name: | Theophylline test |
| Predicate Device: | Diagnostic Reagents, Inc. (DRI) - Theophylline Reagent [510(k) Number K952596] |
Device Description
The ACE® Theophylline Reagent contains two reagents, an Antibody/Substrate reagent and an Enzyme Conjugate reagent. The assay uses specific antibodies to theophylline 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® Theophylline Reagent is intended for use in the quantitative determination of theophylline in human serum.
1
510(k) PREMARKET NOTIFICATION ACE® Theophylline Reagent
SUMMARY OF SAFETY AND EFFECTIVENESS
COMPARATIVE FEATURES OF PREDICATE AND PROPOSED DEVICES
| PARAMETER | PREDICATE DEVICE | PROPOSED DEVICE |
|---|---|---|
| Trade Name | DRI Theophylline Enzyme | |
| Immunoassay | ACE® Theophylline Reagent | |
| Reference No. | K952596 | TBD |
| Analyte | Theophylline | Theophylline |
| Intended Use | Quantitative determination of | |
| theophylline | Quantitative determination of | |
| theophylline | ||
| 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 | |
| 10 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® Theophylline 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 | 0.8 µg/mL to 40 µg/mL | |
| ---------------------- | ---------------------------- | |
| (Per 21 CFR 801.109) |
OR
| Over-The-Counter Use | |
|---|---|
| (Optional Format 1-2-96) |