(99 days)
Not Found
No
The summary describes a rapid immunoassay that measures theophylline concentration based on the height of an enzyme label on a test strip. There is no mention of AI, ML, image processing, or any computational analysis that would suggest the use of these technologies. The measurement is described as "noninstrumented".
No.
The device is an in vitro diagnostic (IVD) test that quantitatively measures Theophylline concentrations, which is used to monitor drug levels, not to directly provide therapy.
Yes
The device quantitatively measures Theophylline concentrations in patient samples, which falls under the definition of a diagnostic test for measuring an analyte to provide information for diagnosis or monitoring.
No
The device description clearly indicates a physical immunoassay test strip that measures the height of an enzyme label, which is a hardware component.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the test provides a method for "in vitro quantitative measurement of Theophylline concentrations". "In vitro" means "in glass" or "outside the body," which is a key characteristic of IVDs.
- Sample Type: The test uses "fingerstick whole blood, heparinized venous whole blood or serum," which are biological specimens taken from the body for testing.
- Purpose: The purpose is to measure the concentration of Theophylline, a substance in the body, to provide information for medical purposes (monitoring drug levels in ambulatory patients).
All of these points align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The ChemTrak AccuMeter® Theophylline Test provides a rapid, noninstrumented enzyme immunochromatographic method for in vitro quantitative measurement of Theophylline concentrations in ambulatory patients using fingerstick whole blood, heparinized venous whole blood or serum. This test has not been validated for use with blood from neonates.
Product codes (comma separated list FDA assigned to the subject device)
KLS
Device Description
The AccuMeter Theophylline Test is a rapid immunoassay for the quantitative detection of theophylline, using HRP labeled anti-theophylline antibodies and immobilized monoclonal anti-theophylline antibodies. The immunospecific signal is measured by the height of the enzyme label along the test strip.
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 validated for use with blood from neonates.
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
Clinical studies were conducted at three sites. A minimum of 40 subjects receiving theophylline therapy were recruited from the patient population at each site. Five to ten theophylline-free subjects were also recruited. Informed consent was obtained from all subjects. The following subject demographic and medical information was collected: age; sex: theophylline dose. Site 1 also tested serum and heparinized whole blood on the AccuMeter. Serum was sent to the reference laboratory for TDx theophylline results.
The accuracy of the AccuMeter Theophylline Test has been demonstrated by correlation to Fluorescence Polarization Immunoassay (TDx) using fingerstick and serum specimens in separate studies.
Testing was performed on individuals receiving theophylline therapy at three independent clinical sites. In 30 out of 149 patients the results were less than the AccuMeter detection limit and were not included for regression analysis. Of the 454 cassettes run on patient samples, the Add Developer Window did not turn green in 6 cassettes and the Control Window did not turn purple in 1 cassette.
The use of fingerstick whole blood, serum, and heparinized whole blood samples in the AccuMeter Theophylline Test was evaluated by parallel testing of 40 patients, by AccuMeter and TDx. at one clinical site. Testing was performed on individuals receiving theophylline therapy.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Accuracy Study:
- Study Type: Correlation to Fluorescence Polarization Immunoassay (TDx).
- Sample Size: 149 patients across three independent clinical sites for correlation study. 102 observations used for regression analysis (after excluding 30 samples below detection limit). For comparison of sample types, 40 patients tested for fingerstick, 39 for serum, and 39 for whole blood.
- Key Results:
- AccuMeter Fingerstick vs. TDx (all sites combined): Slope = 1.05, Intercept = -0.2, Correlation Coefficient = 0.943, N = 102.
- AccuMeter Fingerstick vs. TDx (one site): Slope = 1.06, Intercept = 0.4, Correlation Coefficient = 0.937, N = 40.
- AccuMeter Serum vs. TDx (one site): Slope = 1.03, Intercept = 0.4, Correlation Coefficient = 0.959, N = 39.
- AccuMeter Whole Blood vs. TDx (one site): Slope = 0.99, Intercept = 1.1, Correlation Coefficient = 0.963, N = 39.
Precision Study:
- Study Type: Within-run and total precision studies.
- Sample Size: Two levels of controls tested twice per day in duplicate over 9 to 20 days.
- Study 1: N = 80 for both Level 1 and Level 2 (Within-Run & Total).
- Study 2: N = 80 for both Level 1 and Level 2 (Within-Run & Total).
- Study 3: N = 36 for both Level 1 and Level 2 (Within-Run & Total).
- Key Results:
- Study 1:
- Level 1: Within-Run Mean = 10.8 µg/mL, SD = 0.64 µg/mL, %CV = 5.9. Total Mean = 10.8 µg/mL, SD = 0.82 µg/mL, %CV = 7.6.
- Level 2: Within-Run Mean = 21.3 µg/mL, SD = 1.27 µg/mL, %CV = 6.0. Total Mean = 21.3 µg/mL, SD = 1.43 µg/mL, %CV = 6.7.
- Study 2:
- Level 1: Within-Run Mean = 10.4 µg/mL, SD = 0.80 µg/mL, %CV = 7.7. Total Mean = 10.4 µg/mL, SD = 0.82 µg/mL, %CV = 7.8.
- Level 2: Within-Run Mean = 22.6 µg/mL, SD = 1.34 µg/mL, %CV = 6.0. Total Mean = 22.6 µg/mL, SD = 1.72 µg/mL, %CV = 7.6.
- Study 3:
- Level 1: Within-Run Mean = 10.4 µg/mL, SD = 0.77 µg/mL, %CV = 7.5. Total Mean = 10.4 µg/mL, SD = 1.11 µg/mL, %CV = 10.7.
- Level 2: Within-Run Mean = 21.5 µg/mL, SD = 1.01 µg/mL, %CV = 4.7. Total Mean = 21.5 µg/mL, SD = 1.81 µg/mL, %CV = 8.4.
- Study 1:
Sensitivity Study:
- Study Type: Determination of assay sensitivity.
- Key Results: The sensitivity of the AccuMeter Theophylline assay is 5 ug/mL. Patient samples not containing theophylline may give results in the range 0 - 4.6 ug/mL. Patients whose blood gives a reading of
§ 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
Oct-01-97 02:49P ChemTrak, Inc.
"
408 524 9464
P.03
Addridge
10/1/97 Amendment to 510(k) Number K972495 AccuMeter Theophylline Test
OCT 10 1997
510(k) Summary of Safety and Effectiveness Information Upon Which an Equivalence Determination Could Be Made October 1, 1997
| Device Name:
Common Name: | AccuMeter® Theophylline Test
Theophylline Test System |
|------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use: | The ChemTrak AccuMeter® Theophylline Test provides a
rapid, noninstrumented enzyme immunochromatographic
method for in vitro quantitative measurement of Theophylline
concentrations in ambulatory patients using fingerstick whole
blood, heparinized venous whole blood or serum. This test has
not been validated for use with blood from neonates. |
| Device Description: | The AccuMeter Theophylline Test is a rapid immunoassay
for the quantitative detection of theophylline, using HRP
labeled anti-theophylline antibodies and immobilized
monoclonal anti-theophylline antibodies. The
immunospecific signal is measured by the height of the
enzyme label along the test strip. |
| Device Class: | Class II |
| Classification Panel: | Clinical Toxicology Test Systems |
| Facility Address: | ChemTrak, Inc.
929 East Arques Avenue
Sunnyvale, CA 94086-4520 |
| Contact Name: | SubbaRao Gunupudi, Ph.D.
Vice President Research & Development |
| Telephone: | (408) 773-8156 |
| Fax: | (408) 773-1651 |
| Alternate Contact: | Mark DeLaurentis
Clinical Research Manager |
| Telephone: | (408) 773-8156 |
| Fax: | (408) 773-1651 |
| Predicate Device Name: | TDx®/TDxFLX® Theophylline Monoclonal II
Abbott Laboratories, Abbott Park, IL.
510(k) Number: K932127 |
1
Sample collection and clinical evaluation of the AccuMeter Theophylline Test were performed at three independent clinical sites. IRB approval was obtained for the study protocol. TDx Theophylline testing was performed by a centralized reference laboratory.
Clinical studies were conducted at three sites. A minimum of 40 subjects receiving theophylline therapy were recruited from the patient population at each site. Five to ten theophylline-free subjects were also recruited. Informed consent was obtained from all subjects. The following subject demographic and medical information was collected: age; sex: theophylline dose. Site 1 also tested serum and heparinized whole blood on the AccuMeter. Serum was sent to the reference laboratory for TDx theophylline results.
Accuracy
The accuracy of the AccuMeter Theophylline Test has been demonstrated by correlation to Fluorescence Polarization Immunoassay (TDx) using fingerstick and serum specimens in separate studies.
Testing was performed on individuals receiving theophylline therapy at three independent clinical sites. The least-squares linear regression analysis of all sites combined is shown below (Table 1). In 30 out of 149 patients the results were less than the AccuMeter detection limit and were not included for regression analysis. Of the 454 cassettes run on patient samples, the Add Developer Window did not turn green in 6 cassettes and the Control Window did not turn purple in 1 cassette.
| Y axis: | AccuMeter Fingerstick |
|---|---|
| X axis: | TDx |
| Slope | 1.05 |
| Intercept | -0.2 |
| Correlation Coefficient | 0.943 |
| Number of Observations | 102 |
Table 1: Accuracy -- AccuMeter Compared to TDx Theophylline
2
.
10/1/97 Amendment to 510(k) Number K972495 AccuMeter Theophylline Test
The use of fingerstick whole blood, serum, and heparinized whole blood samples in the AccuMeter Theophylline Test was evaluated by parallel testing of 40 patients, by AccuMeter and TDx. at one clinical site. Testing was performed on individuals receiving theophylline therapy. Results of least-squares linear regression analysis are shown in Table 2.
| Theophylline
Y Axis : | AccuMeter
Fingerstick | AccuMeter
Serum | AccuMeter
Whole Blood |
|--------------------------|--------------------------|--------------------|--------------------------|
| X Axis : | TDx | TDx | TDx |
| Slope | 1.06 | 1.03 | 0.99 |
| Intercept | 0.4 | 0.4 | 1.1 |
| Correlation Coefficient | 0.937 | 0.959 | 0.963 |
| Number of Observations | 40 | 39 | 39 |
| Table 2: Comparison of AccuMeter Fingerstick, Serum and Whole Blood to TDx | ||
|---|---|---|
| Theophylling |
Precision
Precision studies were conducted at three field sites. Two levels of controls were tested twice per day in duplicate over a period of 9 to 20 days. Results appear in Table 3.
3
| | N* | Observed Mean
µg/mL | SD
µg/mL | % CV |
|------------|----|------------------------|-------------|------|
| Study 1 | | | | |
| Within Run | | | | |
| Level 1 | 80 | 10.8 | 0.64 | 5.9 |
| Level 2 | 80 | 21.3 | 1.27 | 6.0 |
| Total | | | | |
| Level 1 | 80 | 10.8 | 0.82 | 7.6 |
| Level 2 | 80 | 21.3 | 1.43 | 6.7 |
| Study 2 | | | | |
| Within Run | | | | |
| Level 1 | 80 | 10.4 | 0.80 | 7.7 |
| Level 2 | 80 | 22.6 | 1.34 | 6.0 |
| Total | | | | |
| Level 1 | 80 | 10.4 | 0.82 | 7.8 |
| Level 2 | 80 | 22.6 | 1.72 | 7.6 |
| Study 3 | | | | |
| Within Run | | | | |
| Level 1 | 36 | 10.4 | 0.77 | 7.5 |
| Level 2 | 36 | 21.5 | 1.01 | 4.7 |
| Total | | | | |
| Level 1 | 36 | 10.4 | 1.11 | 10.7 |
| Level 2 | 36 | 21.5 | 1.81 | 8.4 |
Table 3: Within-Run and Total Precision of AccuMeter Theophylline Test
*The Add Developer Window did not turn green in 8 AccuMeters and the Control Window did not turn purple in 1 AccuMeter.
Sensitivity
The sensitivity of the AccuMeter Theophylline assay is 5 ug/mL. Patient samples not containing theophylline may give results in the range 0 - 4.6 ug/mL. Patients whose blood gives a reading of