← Product Code [KLS](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/KLS) · K972495 # ACCUMETER THEOPHYLLINE TEST (K972495) _Chemtrak, Inc. · KLS · Oct 10, 1997 · Clinical Toxicology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/KLS/K972495 ## Device Facts - **Applicant:** Chemtrak, Inc. - **Product Code:** [KLS](/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/KLS.md) - **Decision Date:** Oct 10, 1997 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 862.3880 - **Device Class:** Class 2 - **Review Panel:** Clinical Toxicology - **Attributes:** Pediatric ## Indications for Use The 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 Story AccuMeter Theophylline Test is a rapid, non-instrumented, enzyme immunochromatographic assay for quantitative theophylline measurement. Input samples include fingerstick whole blood, heparinized venous whole blood, or serum. The device utilizes HRP-labeled anti-theophylline antibodies and immobilized monoclonal anti-theophylline antibodies on a test strip. The immunospecific signal is generated by the height of the enzyme label along the strip, providing a visual quantitative result. Used in clinical settings for ambulatory patients receiving theophylline therapy. Healthcare providers use the visual output to monitor drug concentrations, aiding in therapeutic management and dosage adjustment. Benefits include rapid, point-of-care testing without the need for centralized laboratory instrumentation. ## Clinical Evidence Clinical evaluation conducted at three independent sites with patients receiving theophylline therapy. Accuracy demonstrated via correlation to TDx Fluorescence Polarization Immunoassay. Combined regression analysis (n=102) showed a slope of 1.05, intercept of -0.2, and correlation coefficient of 0.943. Precision studies (within-run and total) performed over 9-20 days showed %CV ranging from 4.7% to 10.7%. Sensitivity is 5 µg/mL. Recovery studies in whole blood showed 99.2% to 108.7% recovery across five concentrations. ## Technological Characteristics Non-instrumented enzyme immunochromatographic assay. Components: single-use cassette, color developer. Detection principle: visual measurement of enzyme label height on test strip. Analyte: theophylline. Assay range: 5-30 µg/mL. Storage: refrigerated. ## Regulatory 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. ## Predicate Devices - TDx®/TDxFLX® Theophylline Monoclonal II ([K932127](/device/K932127.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {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 <5 ug/mL should be reanalyzed by another method. ## Recovery Recovery for the AccuMeter Theophylline Test was determined by spiking theophylline into whole blood at five different concentrations (Table 4). {4}------------------------------------------------ | Table 4: Recovery of Theophylline in Whole Blood | | | | |--------------------------------------------------|----|---------------|-----------------| | Concentration
µg/mL | N | Mean
µg/mL | Recovery
(%) | | 8.3 | 10 | 8.2 | 99.2 | | 12.5 | 10 | 12.6 | 100.7 | | 16.6 | 10 | 17.3 | 104.2 | | 20.7 | 10 | 22.5 | 108.7 | | 24.8 | 10 | 25.7 | 103.8 | covery of Theophylline in Whole Blood D A. T Substantial equivalence has been demonstrated between the AccuMeter Theophylline Test ed the characterial concerner in Wasseleral U.Assoc. The characteristics Substantial equivalence nas ocen uchonsinuline Monoclonal II Assay. The characteristics of and the Abbott TDx®/TDxFLX® Theophylline Monoclonal II Assay (TDx) are and the Abbott TDX&TDXF Theophylline Monoclonal II Assay (TDx) are summarized in Table 5. {5}------------------------------------------------ | | Table 5: Comparison of the AccuMeter Theophylline Test to the TDx Theophylline | |----------------------------------------|---------------------------------------------------------------------------------| | Monoclonal II Assay (Predicate Device) | | | Characteristic
Compared | AccuMeter
Theophylline
(Test Method) | TDx
Theophylline
Monoclonal II
(Predicate Device) | |----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------| | Intended Use | "...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." | "... is a reagent system for
the quantitative
measurement of theophylline
in serum or plasma." | | Analyte | Theophylline | Theophylline | | Methodology | Noninstrumented,
Enzyme Immunochroma-
tographic | Fluorescence Polarization
Immunoassay | | Test Sample | Whole Blood or Serum
No Pretreatment | Serum or Plasma
No Pretreatment | | Test Components | Single-use Cassette
Color Developer | Reagent Kit
Calibrator Kit
Fluorometer | | Assay Range | 5-30 µg/mL | 0.82-40 µg/mL | | Method of
Detection | Visual
Quantitative | Spectrophotometric
Quantitative | | Test Storage | Refrigerated | Refrigerated | The regression data demonstrates substantial equivalence, as well as the safety and effectiveness, of the AccuMeter Theophylline Test to the TDx Theophylline Assay. Prepared and Submitted October 1, 1997 Mark DeLaurentis Clinical Research Manager ChemTrak, Inc., 929 East Arques Avenue, Sunnyvale, CA 94086-4520 {6}------------------------------------------------ Image /page/6/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the bird symbol. The text is in all capital letters and is in a sans-serif font. Food and Drug Administration 2098 Gaither Road Rockville MD 20850 OCT 10 1997 SubbaRao Gunupudi, Ph.D. Vice President Research & Development ChemTrak, Inc. 929 East Arques Avenue Sunnyvale, California 94086 Re : K972495 Trade Name: AccuMeter® Theophylline Test Requlatory Class: II Product Code: KLS Dated: September 15, 1997 September 16, 1997 Received: Dear Dr. Gunupudi: We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth General in the Quality System Regulation (QS) for Medical Devices: regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal Laws or Requlations. {7}------------------------------------------------ Page 2 Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770)488-7655. This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll free number (800) 638-2041 or at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html" Sincerely yours, Steven Autman Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {8}------------------------------------------------ Page of of 510(k) Number (if known): K972495 AccuMeter® Theophylline Test Device Name: Indications For Use: ్లో The AccuMeter® Theophylline Test is a rapid, noninstrumented enzyme immunochromatographic method for the 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. (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) (Division Sign-Off) Division of Clinical Laboratory Devices 510(k) Number. 4972495 | Prescription Use | | |----------------------|--| | (Per 21 CFR 801.109) | | OR Over-The-Counter Use (Optional Format 1-2-96) --- **Source:** [https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/KLS/K972495](https://fda.innolitics.com/submissions/TX/subpart-d%E2%80%94clinical-toxicology-test-systems/KLS/K972495) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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