(71 days)
BM/Hitachi 911
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No
The device description and performance studies describe a standard homogeneous enzyme immunoassay, which does not involve AI or ML. There are no mentions of AI, DNN, or ML in the provided text.
No.
This device is an in vitro diagnostic assay used to measure theophylline levels in human serum and plasma for diagnostic and monitoring purposes, not to provide therapy.
Yes
The "Intended Use / Indications for Use" section states that "Measurements are used in the diagnosis and treatment of theophylline overdose and in monitoring levels of theophylline to ensure proper therapy." This indicates its role in diagnosis.
No
The device description clearly outlines a homogeneous enzyme immunoassay involving chemical reagents and reactions to measure theophylline levels. This is a laboratory-based assay, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "The CEDIA Theophylline Assay is a homogeneous enzyme immunoassay for the in vitro assay of theophylline in human serum and plasma."
The term "in vitro" means "in glass" or "in the laboratory," referring to tests performed outside of a living organism. The description clearly indicates that this assay is used to measure a substance (theophylline) in biological samples (serum and plasma) in a laboratory setting, which is the definition of an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The CEDIA Theophylline Assay is a homogeneous enzyme immunoassay for the in vitro assay of theophylline in human serum and plasma. Measurements are used in the diagnosis and treatment of theophylline overdose and in monitoring levels of theophylline to ensure proper therapy.
Product codes (comma separated list FDA assigned to the subject device)
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Device Description
CEDIA® Technology
The CEDIA® Theophylline Assay is an in-vitro homogeneous enzyme immunoassay used for the measurement of theophylline in serum and plasma. It is based on competitive binding concepts employing theophylline labeled enzymatic fragments (β-galactosidase) competing with sample theophylline for the theophylline -specific antibody. Using recombinant DNA techniques, the β-galactosidase molecule has been split into two totally inactive polypeptide subunits called enzyme acceptor and enzyme donor. Theophylline has been covalently linked to the enzyme donor in a manner that does not prevent spontaneous reassociation of the subunits to yield active β-galactosidase enzyme. Theophylline -specific antibody, by binding to the Theophylline derivative on the enzyme donor will inhibit enzyme reassociation, thereby regulating the level of β-galactosidase formed. The amount of enzyme formed is proportional to the amount of theophylline as monitored by the hydrolysis of the substrate chlorophenol red-β-D-galactopyranoside (CPRG).
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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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)
Precision (Within-run and Total):
Within-run:
Concentration Level - Low: Mean 4.7 µg/mL, SD 0.26 µg/mL, CV 5.5%, N 120
Concentration Level - Mid: Mean 15.1 µg/mL, SD 0.42 µg/mL, CV 2.8%, N 120
Concentration Level - High: Mean 29.2 µg/mL, SD 0.62 µg/mL, CV 2.1%, N 120
Total Precision:
Concentration Level - Low: Mean 4.7 µg/mL, SD 0.30 µg/mL, CV 6.4%, N 120
Concentration Level - Mid: Mean 15.1 µg/mL, SD 0.48 µg/mL, CV 3.2%, N 120
Concentration Level - High: Mean 29.2 µg/mL, SD 0.72 µg/mL, CV 2.5%, N 120
Method Comparison:
A total of 126 serum samples having theophylline values throughout the assay range were tested.
Versus BM/Hitachi 911:
Slope: 1.09
Intercept: -0.60
Correlation: 0.996
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Sensitivity (LDD): 0.8 µg/mL
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.
CEDIA® Theophylline Assay: BM/Hitachi 911
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.
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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
§ 862.3880 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
510(k) SUMMARY
| Subject: | Premarket Notification, 510(k)
CEDIA® Theophylline Assay application: BM/Hitachi 704
Safety and Effectiveness Summary |
|---------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer: | A Boehringer Mannheim Corporation
2400 Bisso Lane
P.O. Box 4117
Concord CA 94524-4117
Phone (510) 674 - 0667
Fax 510 674 1850 |
| Contact: | Betsy Soares-Maddox, Manager of Regulatory Affairs and
Quality Assurance |
| Date: | 14 June 1996 |
| Proprietary Name | CEDIA® Theophylline Assay |
| Common Name | Homogeneous Enzyme Immunoassay for the Determination of
Theophylline Levels in Serum and Plasma. |
| Classification Name | Theophylline Test System |
| Predicate Device | CEDIA® Theophylline Assay: BM/Hitachi 911 |
| Device Description | CEDIA® Technology
The CEDIA® Theophylline Assay is an in-vitro homogeneous
enzyme immunoassay used for the measurement of theophylline
in serum and plasma. It is based on competitive binding concepts
employing theophylline labeled enzymatic fragments (β-
galactosidase) competing with sample theophylline for the
theophylline -specific antibody. |
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| Device Description cont. | Using recombinant DNA techniques, the β-galactosidase molecule has been split into two totally inactive polypeptide subunits called enzyme acceptor and enzyme donor. Theophylline has been covalently linked to the enzyme donor in a manner that does not prevent spontaneous reassociation of the subunits to yield active β-galactosidase enzyme. Theophylline -specific antibody, by binding to the Theophylline derivative on the enzyme donor will inhibit enzyme reassociation, thereby regulating the level of β-galactosidase formed. The amount of enzyme formed is proportional to the amount of theophylline as monitored by the hydrolysis of the substrate chlorophenol red-β-D-galactopyranoside (CPRG). | |
|---|---|---|
| Intended Use | The CEDIA Theophylline Assay is a homogeneous enzyme immunoassay for the in vitro assay of theophylline in human serum and plasma. Measurements are used in the diagnosis and treatment of theophylline overdose and in monitoring levels of theophylline to ensure proper therapy. | |
| Statement of Similarities and Differences | The following table outlines the similarities and differences between the CEDIA Theophylline Assay on the BM/Hitachi 911 to the BM/Hitachi 704. | |
| Parameter | BM/Hitachi 911 | BM/Hitachi 704 |
| Methodology | Homogeneous Enzyme Immunoassay | Homogeneous Enzyme Immunoassay |
| Intended Use | Quantitative Determination of Theophylline | |
| in human serum and plasma | Quantitative Determination of Theophylline | |
| in human serum and plasma | ||
| Detection | ||
| Mechanism | Spectrophotometer at 570 nm | Spectrophotometer at 570 nm |
| Reaction Volumes | ||
| Sample | 3 µL | 4 µL |
| R1 | 130 µL | 185 µL |
| R2 | 130 µL | 170 µL |
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510(k) SUMMARY cont.
| Statement of Similarities
| and Differences, cont. | ||||||
|---|---|---|---|---|---|---|
| Parameter | BM/Hitachi 911 | BM/Hitachi 704 | ||||
| Reagents | Enzyme Acceptor lyophilized with buffer salts, bulking agent, detergent and preservative. |
Enzyme Donor lyophilized with substrate, stabilizer and preservative.
Enzyme Acceptor Reconstitution Buffer with primary antibody, buffer salts, monoclonal anti-Theophylline antibody, stabilizer and preservative.
Enzyme Donor Reconstitution Buffer with buffer salts and preservative. | Same | | | | |
| Sensitivity
(LDD) | 0.8 µg/mL | 0.8 µg/mL | | | | |
| Precision | Dose, µg/mL:
NCCLS modified | Dose, µg/mL:
NCCLS modified | | | | |
| Control Level | Low | Mid | High | Low | Mid | High |
| Within-Run | 5.1 | 15.1 | 29.3 | 4.7 | 15.1 | 29.2 |
| %CV | 3.3 | 1.9 | 1.3 | 5.5 | 2.8 | 2.1 |
| Total | 5.1 | 15.1 | 29.3 | 4.7 | 15.1 | 29.2 |
| %CV | 5.1 | 2.4 | 2.0 | 6.4 | 3.2 | 2.5 |
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| Parameter | BM/Hitachi 911 | BM/Hitachi 704 |
|---|---|---|
| Method Comparison | ||
| Versus: | Fluorescene Polarization Immunoassay | BM/Hitachi 911 |
| Slope | 1.01 | 1.09 |
| Intercept | -0.38 | -0.60 |
| Correlation | 0.997 | 0.996 |
| Performance Characteristics | ||
| Within-run and total precision were analyzed and the following results were obtained: | ||
| Within-run | ||
| Low | Concentration Level | |
| Mid High | ||
| Mean, µg/mL | 4.7 | 15.1 29.2 |
| SD, µg/mL | 0.26 | 0.42 0.62 |
| CV, % | 5.5 | 2.8 2.1 |
| N | 120 | 120 120 |
| Total Precision | ||
| Low | Concentration Level | |
| Mid High | ||
| Mean, µg/mL | 4.7 | 15.1 29.2 |
| SD, µg/mL | 0.30 | 0.48 0.72 |
| CV, % | 6.4 | 3.2 2.5 |
| N | 120 | 120 120 |
| Method Comparison: | ||
| A total of 126 serum samples having theophylline values throughout the assay range were test | ||
| with new CEDIA Theophylline Assay on the BM/Hitachi 911 and the BM/Hitachi 704, and | ||
| yielded the following results: | ||
| Number of | ||
| Observations | Slope | Intercept Correlation |