(41 days)
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No
The summary describes a standard in vitro diagnostic reagent system for quantitative determination of a substance, with performance evaluated using traditional statistical methods. There is no mention of AI or ML terms, image processing, or data training/testing sets.
No
The device is an in vitro diagnostic reagent system used for quantitative determination of theophylline, which aids in diagnosis and monitoring, but does not directly deliver therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that "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," and the "Device Description" also mentions "in vitro diagnostic reagent system."
No
The device description explicitly states it is an "in vitro diagnostic reagent system" and is used with "automated clinical chemistry analyzers," indicating it is a physical reagent kit and requires hardware for operation, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
The document explicitly states in both the "Intended Use / Indications for Use" and "Device Description" sections that the Roche ONLINE Theophylline assay contains an in vitro diagnostic reagent system. It also describes its use for quantitative determination of a substance in human serum or plasma, which are biological specimens tested outside of the body.
N/A
Intended Use / Indications for Use
The Roche ONLINE Theophylline assay contains an in vitro diagnostic reagent system indicated for the quantitative determination of theophylline, a broncodilator, widely used to treat patients with asthma, apnea (temporary asphyxia), and other obstructive lung diseases. 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.
Product codes (comma separated list FDA assigned to the subject device)
KLS
Device Description
The Roche ONLINE Theophylline assay contains an in vitro diagnostic reagent system indicated for the quantitative determination of theophylline, a bronchodilator, widely used to treat patients with asthma, apnea (temporary asphyxia), and other obstructive lung diseases, in human serum or plasma on automated clinical chemistry analyzers. Measurements obtained by the device are used in the diagnosis and treatment of theophylline overdose and in monitoring levels of theophylline to ensure appropriate therapy. The proposed labeling indicates that the Roche/Hitachi 911, 912, 917, and Modular P analyzers can be used with the Roche ONLINE Theophylline reagent kits.
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)
The Roche ONLINE Theophylline was evaluated for several performance characteristics, including precision, lower detection limit, method comparison, specificity, and interfering substances. All of the evaluation studies gave acceptable results compared to the predicate device. These experiments provide evidence that the Roche ONLINE Theophylline Assay is substantially equivalent to the currently marketed Roche COBAS INTEGRA Theophylline Assay.
Method Comparison:
Roche/Hitachi 917 versus Theophylline assay on the COBAS INTEGRA 700: n = 103, y = 0.976x + 0.011, R = 0.996, Range = 0.62 to 39.6 μg/mL
Versus COBAS FARA II Theophylline assay: n = 138, y = 0.963x + 0.065, R = 0.998, Range = 0.16 to 36.3 μg/mL
Precision:
Level 1: Mean (μg/mL) = 4.87, CV% (within run) = 1.0, CV% (total) = 1.9
Level 2: Mean (μg/mL) = 14.51, CV% (within run) = 0.5, CV% (total) = 1.7
Level 3: Mean (μg/mL) = 24.31, CV% (within run) = 0.9, CV% (total) = 2.1
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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).
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§ 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.
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APR 1 6 2002
Roche ONLINE Theophylline Assay
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 | Roche Diagnostics Corporation |
| 9115 Hague Rd. | |
| Indianapolis, IN 46250 | |
| (317) 845-2000 |
Contact Person: Mike Flis
Date Prepared: April 2, 2002 |
| 2) Device name | Roche ONLINE Theophylline |
| 3) Predicate device | We claim substantial equivalence to the COBAS INTEGRA Theophylline assay. |
| 4) Device Description | The Roche ONLINE Theophylline assay contains an in vitro diagnostic reagent system indicated for the quantitative determination of theophylline, a bronchodilator, widely used to treat patients with asthma, apnea (temporary asphyxia), and other obstructive lung diseases, in human serum or plasma on automated clinical chemistry analyzers. Measurements obtained by the device are used in the diagnosis and treatment of theophylline overdose and in monitoring levels of theophylline to ensure appropriate therapy. The proposed labeling indicates that the Roche/Hitachi 911, 912, 917, and Modular P analyzers can be used with the Roche ONLINE Theophylline reagent kits. |
| 5) Intended use | For the quantitative determination of theophylline in human serum or plasma on automated clinical chemistry analyzers. |
Continued on next page
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510(k) Summary, continued
The Roche ONLINE Theophylline was evaluated for several performance 6) Comparison characteristics, including precision, lower detection limit, method to predicate comparison, specificity, and interfering substances. All of the evaluation device studies gave acceptable results compared to the predicate device. These experiments provide evidence that the Roche ONLINE Theophylline Assay is substantially equivalent to the currently marketed Roche COBAS INTEGRA Theophylline Assay. The following table presents the precision and method comparison results.
| Roche ONLINE Theophylline | | | | Roche COBAS INTEGRA
Theophylline (Predicate) | | |
|---------------------------------------------|---------|---------|---------|-------------------------------------------------|---------|---------|
| Roche/Hitachi 917 versus Theophylline assay | | | | Versus COBAS FARA II Theophylline | | |
| on the COBAS INTEGRA 700 | | | | assay | | |
| n = 103 | | | | n = 138 | | |
| $y = 0.976x + 0.011$ | | | | $y = 0.963x + 0.065$ | | |
| R = 0.996 | | | | R = 0.998 | | |
| Range = 0.62 to 39.6 μg/mL | | | | Range = 0.16 to 36.3 μg/mL | | |
| Precision: | Level 1 | Level 2 | Level 3 | Level 1 | Level 2 | Level 3 |
| Mean (μg/mL) | 4.87 | 14.51 | 24.31 | 5.4 | 14.2 | 22.5 |
| CV% (within run) | 1.0 | 0.5 | 0.9 | 1.6 | 1.9 | 1.8 |
| CV% (total) | 1.9 | 1.7 | 2.1 | 2.6 | 2.6 | 2.8 |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or clothing.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. Mike Flis Regulatory Affairs Principal Roche Diagnostics Corporation 9115 Hague Road P.O. Box 50457 Indianapolis, Indiana 46250-0457
Re: K020740
Trade/Device Name: Roche ONLINE Theophylline Regulation Number: 21 CFR § 862.3880 Regulation Name: Theophylline Test System Regulatory Class: II Product Code: KLS Dated: March 1, 2002 Received: March 6, 2002
Dear Mr. Flis:
This letter corrects the letter dated April 9, 2002. The indications for use, was amended by Roche and a copy of new indications for use has been added to the file. We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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.
APR 2 4 2002
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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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" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Steven Sutman
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
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Roche Diagnostics Corporation
510(k) Number (if known): K020740 Device Name: Roche ONLINE Theophylline Assay Indications for Use:
The Roche ONLINE Theophylline assay contains an in vitro diagnostic reagent system indicated for the quantitative determination of theophylline, a broncodilator, widely used to treat patients with asthma, apnea (temporary asphyxia), and other obstructive lung diseases. 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.
Dan Cooper
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K020740
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use √
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)