(73 days)
Not Found
No
The device description details a standard enzymatic reaction and colorimetric measurement, followed by linear least squares regression for calibration and interpolation. There is no mention of AI or ML algorithms for data analysis or interpretation.
No
This device is an in vitro diagnostic reagent system used for the quantitative determination of acetaminophen levels in human samples, not for treatment or therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "an in vitro diagnostic reagent system intended for use on the COBAS INTEGRA analyzer for the quantitative determination of toxic levels of acetaminophen in human serum or heparinized plasma." This falls under the definition of a diagnostic device.
No
The device description clearly outlines a reagent system and an analyzer (COBAS INTEGRA 700) that performs enzymatic reactions and colorimetric measurements. This involves physical components and chemical processes, not solely software.
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 device is an "in vitro diagnostic reagent system."
- Device Description: The "Device Description" further clarifies that it's an "in vitro diagnostic reagent system" used for the quantitative determination of acetaminophen in human serum or plasma.
- Nature of the Test: The description of the enzymatic reaction and colorimetric measurement clearly indicates that the test is performed on biological samples outside of the body (in vitro).
Therefore, based on the provided information, this device fits the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The cassette COBAS INTEGRA Acetaminophen contains and in vitro diagnostic reagent system intended for use on the COBAS INTEGRA analyzer for the quantitative determination of toxic levels of acetaminophen in human serum or heparinized plasma.
Product codes (comma separated list FDA assigned to the subject device)
LDP
Device Description
The Roche COBAS INTEGRA Acetaminophen assay contains an in vitro diagnostic reagent system intended for use on the COBAS INTEGRA 700 analyzer for the quantitative determination of toxic levels of acetaminophen in human serum or heparinized plasma.
The COBAS INTEGRA Acetaminophen assay determinations are made on the COBAS INTEGRA 700 analyzer using an enzymatic reaction. Acetaminophen is hydrolyzed by an arylacylamidase to yield p-aminophenol and acetate. Subsequently the p-aminophenol is converted to an indophenol in the presence of o-cresol and a periodate catalyst. The production of indophenol is followed colorimetrically.
The change in absorbance is directly proportional to the quantitative drug concentration in serum.
The COBAS INTEGRA 700 analyzer calculates the change in absorbance units (ΔΑ/min). After ΔΑ/min values have been calculated for the calibrators, the system calculates a best-fit curve for the calibrators using a linear least squares regression analysis. The concentration of drug in each sample is then interpolated from this curve using its measured AA/min value.
Mentions image processing
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Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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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)
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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.
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
§ 862.3030 Acetaminophen test system.
(a)
Identification. An acetaminophen test system is a device intended to measure acetaminophen, an analgestic and fever reducing drug, in serum. Measurements obtained by this device are used in the diagnosis and treatment of acetaminophen overdose.(b)
Classification. Class II.
0
JUL 222 1999
1991598
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) 576-3362 | |
| Contact person: Lisa M. Gerard | |
| Date prepared May 7, 1999 | |
| 2) Device name | Proprietary name: COBAS INTEGRA Acetaminophen |
| Common name: Enzymatic assay for the determination of acetaminophen | |
| Classification name: Acetaminophen test system | |
| 3) Predicate device | We claim substantial equivalence to the COBAS INTEGRA Acetaminophen (K954992). |
:
Continued on next page
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1
510(k) Summary, Continued
- Device The Roche COBAS INTEGRA Acetaminophen assay contains an in vitro description diagnostic reagent system intended for use on the COBAS INTEGRA 700 analyzer for the quantitative determination of toxic levels of acetaminophen in human serum or heparinized plasma.
The COBAS INTEGRA Acetaminophen assay determinations are made on the COBAS INTEGRA 700 analyzer using an enzymatic reaction. Acetaminophen is hydrolyzed by an arylacylamidase to yield p-aminophenol and acetate. Subsequently the p-aminophenol is converted to an indophenol in the presence of o-cresol and a periodate catalyst. The production of indophenol is followed colorimetrically.
The change in absorbance is directly proportional to the quantitative drug concentration in serum.
The COBAS INTEGRA 700 analyzer calculates the change in absorbance units (ΔΑ/min). After ΔΑ/min values have been calculated for the calibrators, the system calculates a best-fit curve for the calibrators using a linear least squares regression analysis. The concentration of drug in each sample is then interpolated from this curve using its measured AA/min value.
Continued on next page
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic that resembles an abstract representation of a human form or a symbol related to health and well-being.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JUL 222 1999
Ms. Lisa M. Gerard Regulatory Affairs Consultant Roche Diagnostics Corporation 9115 Hague Road P.O. Box 50457 Indianapolis, Indiana 50457
Re: Kodi 200
Trade Name: Roche COBAS INTEGRA Acetaminophen Regulatory Class: II Product Code: LDP Dated: May 7, 1999 Received: May 10, 1999
Dear Ms. Gerard:
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 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). 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 requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General 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 regulatory 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 regulations.
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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 (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/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
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Indications for Use Statement
| 510(k) Number (if known): | K991598 |
|---|---|
| Device Name: | COBAS INTEGRA Acetaminophen |
| Indications for Use: | The cassette COBAS INTEGRA Acetaminophen contains and in vitro diagnostic reagent system intended for use on the COBAS INTEGRA analyzer for the quantitative determination of toxic levels of acetaminophen in human serum or heparinized plasma. |
(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) |
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number: K991598
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