(56 days)
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Not Found
No
The summary describes a standard in vitro diagnostic reagent kit for a clinical chemistry analyzer, with no mention of AI or ML technologies.
No
The device is an in vitro diagnostic reagent system used for quantitative determination of acetaminophen levels, which aids in diagnosis and treatment, but it does not directly provide therapy.
Yes
The 'Intended Use / Indications for Use' section explicitly states: "Measurements obtained by this device are used in the diagnosis and treatment of acetaminophen overdose."
No
The device is an in vitro diagnostic reagent system used on automated clinical chemistry analyzers, which are hardware devices. The 510(k) describes a reagent kit, not a software application.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states "For the quantitative determination of toxic levels of acetaminophen in human serum or plasma". This involves testing biological samples in vitro (outside the body).
- Device Description: The description refers to it as an "in vitro diagnostic reagent system".
- Sample Type: It uses "human serum or plasma", which are biological samples.
- Purpose: The measurements are used "in the diagnosis and treatment of acetaminophen overdose", which is a diagnostic purpose.
All of these points align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
For the quantitative determination of toxic levels of acetaminophen in human serum or plasma on automated clinical chemistry analyzers. Measurements obtained by this device are used in the diagnosis and treatment of acctaminophen overdose.
Product codes
LDP
Device Description
The Roche Acetaminophen assay contains an in vitro diagnostic reagent system indicated for the quantitative determination of toxic levels of acetaminophen in human serum or plasma on automated clinical chemistry analyzers. The proposed labeling indicates the Roche/Hitachi 911, 912, 917, and Modular P analyzers can be used with the Roche Acetaminophen 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
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
The Roche COBAS INTEGRA Acetaminophen 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 Acetaminophen Assay is substantially equivalent to the currently marketed Roche COBAS INTEGRA Acetaminophen Assay.
Precision:
Roche Acetaminophen:
Level 1: Mean (ug/mL) = 7.9, CV% (withinrun) = 5.6, CV% (day to day) = 5.7, CV% (total) = 5.7
Level 2: Mean (ug/mL) = 34.83, CV% (withinrun) = 1.2, CV% (day to day) = 1.0, CV% (total) = 1.9
Level 3: Mean (ug/mL) = 102.13, CV% (withinrun) = 0.5, CV% (day to day) = 1.4, CV% (total) = 1.4
Method Comparison:
Roche Acetaminophen versus Roche COBAS INTEGRA Acetaminophen assay on the COBAS Integra 700.
N = 150
Y = -0.31 + 0.987x
R = 0.999
Range = 1.2 to 160.6 ug/mL
Roche COBAS INTEGRA Acetaminophen, (Predicate) versus Abbott TDx Acetaminophen assay.
N = 87
Y = 1.047x – 6.689
R = 0.984
Range = 0-234.7μg/mL
Level 1: 9.9 mean, CV% (within) = 1.8, CV% (day to day) = 3.7, CV% (total) = 7.5
Level 2: 32.9 mean, CV% (within) = 0.9, CV% (day to day) = 4.0, CV% (total) = 4.4
Level 3: 97.4 mean, CV% (within) = 0.7, CV% (day to day) = 4.3, CV% (total) = 4.9
Key Metrics
Not Found
Predicate Device(s)
COBAS INTEGRA Acetaminophen Assay.
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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
JAN 8 2002
Roche Acetaminophen Assay
| 510(k) Summary |
|---|
| ---------------- |
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: | November 9, 2001 |
| 2) Device name | Roche Acetaminophen |
|---|---|
| ----------------------- | --------------------- |
| 3) Predicate device | We claim substantial equivalence to the COBAS INTEGRA Acetaminophen Assay. |
|---|---|
| ---------------------------- | ---------------------------------------------------------------------------- |
| 4) Device Description | The Roche Acetaminophen assay contains an in vitro diagnostic reagent system indicated for the quantitative determination of toxic levels of acetaminophen in human serum or plasma on automated clinical chemistry analyzers. The proposed labeling indicates the Roche/Hitachi 911, 912, 917, and Modular P analyzers can be used with the Roche Acetaminophen reagent kits. |
|---|---|
| ------------------------------ | -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
Continued on next page
1
510(k) Summary, Continued
Y = -0.31 + 0.987x
Range = 1.2 to 160.6 ug/mL
Level 1
7.9
5.6
5.7
5.7
R =0.999
Precision:
Mean (μg/mL)
CV% (withinnun)
CV% (day to day)
CV% (total)
)
-
Intended use For the quantitative determination of toxic levels of acetaminophen in human serum or plasma on automated clinical chemistry analyzers.
-
Comparison to predicate device The Roche COBAS INTEGRA Acetaminophen 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 Acetaminophen Assay is substantially equivalent to the currently marketed Roche COBAS INTEGRA Acetaminophen Assay. The following table presents the precision and method comparison results.
| Roche Acetaminophen | Roche COBAS INTEGRA Acetaminophen, (Predicate) | |
|---|---|---|
| Versus Roche COBAS INTEGRA Acetaminophen assay on the COBAS Integra 700 | Versus Abbott TDx Acetaminophen assay | |
| N = 150 | N=87 | |
| Y=1.047x – 6.689 |
R=0.984
Level 1
9.9
న.8
3.7
7.5
Level 3
102.13
0:5
1.4
1.4
Level 2
34.83
1.2
1.0
ાં .ડ
Range = 0-234.7μg/mL
Level 2
32.9
0.9
4.0
4.4
Level 3
97.4
0.7
4.3
4.9
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a stylized human figure with outstretched arms. The symbol is composed of three curved lines that suggest movement or flight.
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, IN 46250-0457
JAN 8 2002
Re: K013757
Trade/Device Name: Roche Acetaminophen Assay Regulation Number: 21 CFR 862.3030 Regulation Name: Acetaminophen test system Regulatory Class: Class II Product Code: LDP Dated: November 9, 2001 Received: November 13, 2001
Dear Mr. Flis:
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.
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 (QS) 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 nredicate 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 1 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/cdrb/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
4
Roche Diagnostics Corporation
510(k) Number (if known): K013757 Device Name: Roche Acetaminophen Assay Indications for Use:
For the quantitative determination of toxic levels of acetaminophen in human serum or plasma on automated clinical chemistry analyzers. Measurements obtained by this device are used in the diagnosis and treatment of acctaminophen overdose.
-Off)
Division. Clinical Laboratory Devices
510(k) Number K013757
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
OR
Prescription Use V (Per 21 CFR 801.109) Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)