(57 days)
Not Found
No
The device description details a biochemical immunoassay based on enzyme activity and spectrophotometric measurement, with no mention of AI or ML algorithms for data analysis or interpretation.
No.
This device is an immunoassay for the in vitro quantitative determination of phenytoin, which means it measures the concentration of a substance (phenytoin) in a sample to aid in diagnosis or monitoring, not to treat a condition.
Yes
The device is an immunoassay for the quantitative determination of phenytoin in human serum and plasma, which is used to measure specific analytes in the body, a key function of diagnostic devices.
No
The device description clearly outlines a chemical immunoassay based on enzyme activity and spectrophotometric measurement, indicating it is a laboratory diagnostic kit with physical reagents and a need for a spectrophotometer, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" explicitly states "Immunoassay for the in vitro quantitative determination of phenytoin in human serum and plasma." The term "in vitro" is a key indicator of an IVD.
- Sample Type: The assay is performed on "human serum and plasma," which are biological samples taken from the body but tested outside of it.
- Measurement: The device performs a "quantitative determination" of phenytoin, meaning it measures the amount of the substance in the sample. This is a typical function of an IVD used for diagnostic purposes.
- Device Description: The description details a laboratory-based assay using enzymatic reactions and spectrophotometric measurement, which are common techniques used in IVD devices.
The information provided clearly aligns with the definition of an In Vitro Diagnostic device, which is used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or screening purposes.
N/A
Intended Use / Indications for Use
Immunoassay for the in vitro quantitative determination of phenytoin in human serum and plasma.
Product codes (comma separated list FDA assigned to the subject device)
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Device Description
The CEDIA® Phenytoin II Assay is based on the bacterial enzyme Bgalactosidase, which has been genetically engineered into two inactive fragments. These fragments spontaneously reassociate to form fully active enzyme that, in the assay format, cleaves a substrate, generating a color change that can be measured spectrophotometrically.
In the assay, phenytoin in the sample competes with analyte conjugated to one inactive fragment of ß-galactosidase for antibody binding site. If analyte is present in the sample, it binds to antibody, leaving the inactive enzyme fragments free to form active enzyme. If analyte is not present in the sample, antibody binds to analyte conjugated on the inactive fragment, inhibiting the reassociation of inactive ß-galactosidase fragments, and no active enzyme is formed.
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
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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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)
Performance Characteristics:
Precision: Modified NCCLS (µg/mL)
| Level | Sample | Control 2 | Control 3 | Low | Mid | High |
|---|---|---|---|---|---|---|
| N | 120 | 120 | 120 | 120 | 120 | 119 |
| Within-Run | 6.30 | 14.80 | 26.75 | 10.7 | 17.7 | 35.4 |
| %CV | 3.2 | 2.0 | 1.3 | 3.6 | 2.0 | 1.5 |
| Total | 6.30 | 14.80 | 26.75 | 10.7 | 17.7 | 35.4 |
| %CV | 5.1 | 3.1 | 2.3 | 4.7 | 3.8 | 3.3 |
Lower Detection Limit: 0.6 µg/mL
Linearity: 0.6 - 40.0 µg/mL
Method Comparison (Vs CEDIA® Phenytoin): N=114, Least Squares: y = 1.00x - 0.17, r=0.998, SEE = 0.55; Deming's: y = 1.00x - 0.19, r=0.998, SEE = 0.39
Method Comparison (Vs Abbott TDx® Phenytoin): N=92, Least Squares: y = 0.984x - 0.10, r=0.994, SEE = null
Interfering substances (No interference at):
Bilirubin: 66 mg/dL
Hemoglobin: 1000 mg/dL
Lipemia: 1000 mg/dL
Total Protein: 12.0 g/dL
Rheumatoid Factor: 100 IU/mL
Specificity (% Cross-reactivity):
HPPH: 1.8%
5-MPPH: 5.7%
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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
NOV 201996
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Image /page/0/Picture/2 description: The image shows the word "Diagnostics" in a serif font. To the left of the word is a dark, blurry image that is difficult to make out. Below the word "Diagnostics" are the words "munudu" and a colon. The image appears to be a scan of a document.
510(k) Summary
| Introduction | According to the requirements of 21 CFR 807.92, the following information provides sufficient detail to understand the basis for a determination of substantial equivalence. |
|---|---|
| 1. Submitter name, address, contact | Boehringer Mannheim Corporation |
| 2400 Bisso Lane | |
| P.O. Box 4117 | |
| Concord, CA 94524-4117 | |
| (510) 674 - 0690, extension 8413 | |
| Contact Person: Yvette Lloyd | |
| Date Prepared: September 20, 1996 | |
| 2. Device name | Proprietary name: CEDIA® Phenytoin II Assay |
| Common name: Homogeneous enzyme immunoassay for the determination of phenytoin. | |
| Classification name: Enzyme immunoassay, Diphenylhydantoin | |
| 3. Predicate device | The Boehringer Mannheim CEDIA® Phenytoin II Assay is substantially equivalent to other products in commercial distribution intended for similar use. Most notably it is substantially equivalent to the currently marketed CEDIA® Phenytoin Assay (K905689). |
1
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Diagnostics
4. Device Description
The CEDIA® Phenytoin II Assay is based on the bacterial enzyme Bgalactosidase, which has been genetically engineered into two inactive fragments. These fragments spontaneously reassociate to form fully active enzyme that, in the assay format, cleaves a substrate, generating a color change that can be measured spectrophotometrically.
In the assay, phenytoin in the sample competes with analyte conjugated to one inactive fragment of ß-galactosidase for antibody binding site. If analyte is present in the sample, it binds to antibody, leaving the inactive enzyme fragments free to form active enzyme. If analyte is not present in the sample, antibody binds to analyte conjugated on the inactive fragment, inhibiting the reassociation of inactive ß-galactosidase fragments, and no active enzyme is formed.
ડ. Intended use Immunoassay for the in vitro quantitative determination of phenytoin in human serum and plasma.
- Comparison to predicate device
The Boehringer Mannheim CEDIA® Phenytoin II Assay is substantially equivalent to other products in commercial distribution intended for similar use. Most notably it is substantially equivalent to the currently marketed CEDIA® Phenytoin Assay (K905689).
The following table compares the CEDIA® Phenytoin II Assay with the predicate device, CEDIA® Phenytoin Assay. Specific data on the performance of the test have been incorporated into the draft labeling in attachment 5. Labeling for the predicate device is provided in attachment 6.
Similarities:
·Intended Use: Immunoassay for the in vitro quantitative determination of phenytoin
- ·Sample type: Serum and plasma
- · Assay range: 0 40 µg/mL
- · Same Antibody
- · Same Conjugate
Continued on next page
2
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510(k) Summary, Continued
Differences:
ﯩﯔ ﺋﯧﺘﯩ
ﺴﺴﺔ
Comparison
to predicate
device cont.
| Feature | CEDIA® Phenytoin II | CEDIA® Phenytoin |
|---|---|---|
| Reaction test | ||
| principle | Spectrophotometric | |
| 570 nm | Spectrophotometric | |
| 415 nm | ||
| Instrument | ||
| required | Hitachi 911 | Hitachi 704 |
| Enzyme | ||
| Substrate | CPRG (Chlorophenol red-β- | |
| D-Galactopyranoside) | m-CNPG (m-Cyano-p- | |
| nitrophenol-β-D- | ||
| galactopyranoside) |
Performance Characteristics:
| Feature | CEDIA® Phenytoin II | CEDIA® Phenytoin | ||||
|---|---|---|---|---|---|---|
| Precision | Modified NCCLS (µg/mL): | Modified NCCLS (µg/mL): | ||||
| Level | Sample | Control 2 | Control 3 | Low | Mid | High |
| N | 120 | 120 | 120 | 120 | 120 | 119 |
| Within-Run | 6.30 | 14.80 | 26.75 | 10.7 | 17.7 | 35.4 |
| %CV | 3.2 | 2.0 | 1.3 | 3.6 | 2.0 | 1.5 |
| Total | 6.30 | 14.80 | 26.75 | 10.7 | 17.7 | 35.4 |
| %CV | 5.1 | 3.1 | 2.3 | 4.7 | 3.8 | 3.3 |
Continued on next page
3
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វ
510(k) Summary, Continued
Performance Characteristics:
Comparison
to predicate
device, (cont.)
7
| Feature | CEDIA® Phenytoin II | TDx Phenytoin |
|---|---|---|
| Lower | ||
| Detection | ||
| Limit | 0.6 µg/mL | 0.6 µg/mL |
| Linearity | 0.6 - 40.0 µg/mL | 0.6 - 40.0 µg/mL |
| Method | ||
| Comparison | Vs CEDIA® | |
| Phenytoin | ||
| Least Squares | ||
| $y =1.00x - 0.17$ | ||
| r=0.998 | ||
| SEE =0.55 | ||
| N=114 |
Deming's
$y =1.00x - 0.19$
r=0.998
SEE =0.39
N=114 | Vs Abbott TDx®
Phenytoin
Least Squares
$y =0.984x - 0.10$
r=0.994
SEE = null
N=92 |
Continued on next page
4
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510(k) Summary, Continued
Comparison
to predicate
device, (cont.)
Performance Characteristics:
| Feature | CEDIA® Phenytoin II | CEDIA Phenytoin |
|---|---|---|
| Interfering | ||
| substances | No interference at: | No interference at: |
| Bilirubin | 66 mg/dL | 50 mg/dL |
| Hemoglobin | 1000 mg/dL | 1000 mg/dL |
| Lipemia | 1000 mg/dL | 1000 mg/dL |
| Total Protein | 12.0 g/dL | 13 g/dL |
| Rheumatoid | ||
| Factor | 100 IU/mL | 180 IU/mL |
| Specificity | % Cross-reactivity | % Cross-reactivity |
| HPPH | 1.8% | 1.4% |
| 5-MPPH | 5.7% | 4.8% |
$\xi$