(282 days)
No
The description details a standard chemical assay and mentions no AI/ML components or methodologies.
No
This device is an in vitro diagnostic test for the quantitative determination of acetaminophen levels, not a device used for treating a disease or condition.
Yes
Explanation: The device is an "in vitro test for the quantitative determination of toxic levels of acetaminophen in serum and plasma," which is used to diagnose acetaminophen toxicity.
No
The device description clearly states it is an "in vitro test" utilizing "reagents" and "automated clinical chemistry analyzers" to measure a chemical reaction. 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 assay is an "in vitro test for the quantitative determination of toxic levels of acetaminophen in serum and plasma". The term "in vitro" is a key indicator of an IVD.
- Device Description: The description details how the assay works by analyzing a sample (serum and plasma) outside of the body to measure a substance (acetaminophen). This is the fundamental principle of an IVD.
- Sample Type: The assay uses "serum and plasma," which are biological samples taken from a patient. IVDs are designed to analyze such samples.
- Analyzers: The assay is used on "automated clinical chemistry analyzers," which are common platforms for performing in vitro diagnostic tests in a laboratory setting.
The information provided clearly aligns with the definition and characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Roche Acetaminophen assay is an in vitro test for the quantitative determination of toxic levels of acetaminophen in serum and plasma on Roche COBAS Integra, Roche/ Hitachi and cobas c system analyzers.
Product codes (comma separated list FDA assigned to the subject device)
LDP
Device Description
The Roche Diagnostics Acetaminophen assays under consideration in this submission are the same assays as were cleared on the COBAS Integra in K991598, Hitachi 917 in K013757 and cobas c501 in K060373 for the quantitative determination of toxic levels of Acetaminophen in human serum and plasma on automated clinical chemistry analyzers. The same reagents are used on all three systems. 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 the sample.
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 Found
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Analytical Sensitivity:
Cobas c501: LoB 1.2 µg/ml, LoD 2.4 µg/ml, LoQ 15 µg/ml
Hitachi 917: LoB 1.2 µg/ml, LoD 2.4 µg/ml, LoQ 15 µg/ml
COBAS Integra: LoB 1.2 µg/ml, LoD 2.4 µg/ml, LoQ 15.0 µg/ml
Measuring range:
Cobas c501: 15-500 µg/ml
Hitachi 917: 15-500 µg/ml
COBAS Integra: 15-300 µg/ml
Interferences:
Bilirubin interference at Acetaminophen level of 15, 30 and 50 µg/ml for Cobas c501, Hitachi 917, and COBAS Integra.
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
510(k) Summary: Roche cobas 8000 Modular Analyzer Series (Revised 12-20-2011)
| Introduction | The information in this 510(k) Summary is being submitted in accordance
with the requirements of 21 CFR 807.92. |
|------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter
name, address,
contact | Roche Diagnostics
9115 Hague Rd
Indianapolis IN 46250
Contact person: Angelo Pereira
Phone: 317-521-3544
Fax: 317-521-2324
Email : angelo.pereira@roche.com
Date prepared: December 20, 2011 |
| Device Name | Proprietary name: Roche Acetaminophen assay
Common names: Enzymatic assay for the determination of acetaminophen
Classification names: Acetaminophen test system (21 CFR 862.3030).
Product code LDP |
| Predicate
Device | We claim substantial equivalence to the following predicate devices: Roche
COBAS Integra Acetaminophen assay (K991598), the Roche/Hitachi
Acetaminophen assay (K013757) and the cobas c501 Acetaminophen assay
(K060373). |
| Intended use /
Indications for
use | The Roche Acetaminophen assay is an in vitro test for the quantitative
determination of toxic levels of acetaminophen in serum and plasma on
Roche COBAS Integra, Roche/ Hitachi and cobas c system analyzers. |
| Device
Description | The Roche Diagnostics Acetaminophen assays under consideration in this
submission are the same assays as were cleared on the COBAS Integra in
K991598, Hitachi 917 in K013757 and cobas c501 in K060373 for the
quantitative determination of toxic levels of Acetaminophen in human serum
and plasma on automated clinical chemistry analyzers. The same reagents are
used on all three systems.
Acetaminophen is hydrolyzed by an arylacylamidase to yield p-aminophenol |
DEC 2 3 2011
1
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 the sample.
The following tables illustrate the similarities and differences between the current Acetaminophen assays and the predicate assays
| Feature | Cobas c501
Acetaminophen | Cobas c501
Acetaminophen
(Predicate K060373) |
|------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------|
| Indications for Use | In Vitro test for the
quantitative determination
of toxic levels of
acetaminophen in serum
and plasma on Roche/
Hitachi and cobas c systems | Same |
| Technology | Enzymatic- end point | Same |
| Sample types | Serum and plasma | Same |
| Calibrators | COBAS Integra calibrators | Same |
| Reagents | R1: Sodium periodote 3.75
mmol/L
R2: Arlyacylamidase
(microbial)≥7000U/L: o-
cresol 3.75 mmol/L | Same |
| Analytical Sensitivity | LoB 1.2 µg/ml
LoD 2.4 µg/ml
LoQ 15 µg/ml | Lower detection level
(LDL) 1.2 µg/ml |
| Measuring range | 15-500 µg/ml | 1.2-500 µg/ml |
| Interferences | Bilirubin interference at
Acetaminophen level of 15,
30 and 50 µg/ml | Bilirubin interference at
Acetaminophen level of
50µg/ml |
Table A- cobas c501
2
Table B- Hitachi 917
1
| Feature | Hitachi 917
Acetaminophen | Hitachi 917
Acetaminophen
(Predicate K060373) |
|------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------|
| Indications for Use | The Roche Acetaminophen
assay is for the quantitative
determination of toxic
levels of acetaminophen in
human serum or plasma on
automated clinical
chemistry analyzers | Same |
| Technology | Enzymatic- end point | Same |
| Sample types | Serum and plasma | Same |
| Calibrators | COBAS Integra calibrators | Same |
| Reagents | R1: Sodium periodote 3.75
mmol/L
R2: Arlyacylamidase
(microbial)≥7000U/L; o-
cresol 3.75 mmol/L | Same |
| Analytical Sensitivity | LoB 1.2 µg/ml
LoD 2.4 µg/ml
LoQ 15 µg/ml | Lower detection level
(LDL) 1.2 µg/ml |
| Measuring range | 15-500 µg/ml | 1.2-600 µg/ml |
| Interferences | Bilirubin interference at
Acetaminophen level of 15,
30 and 50 µg/ml. | Bilirubin interference at
Acetaminophen level of
50µg/ml |
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| Feature | COBAS Integra
Acetaminophen | COBAS Integra
Acetaminophen
(Predicate K991598) |
|------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------|
| Indications for Use | In Vitro test for the
quantitative determination
of toxic levels of
acetaminophen in serum or
heparinized plasma on
COBAS INTEGRA systems | Same |
| Technology | Enzymatic- end point | Same |
| Sample types | Serum and plasma | Same |
| Calibrators | COBAS Integra calibrators | Same |
| Reagents | R1: Arlyacylamidase
(microbial)≥7000U/L; o-
cresol 3.75 mmol/L
R2: Sodium periodote 3.75
mmol/L | Same |
| Analytical Sensitivity | LoB 1.2 µg/ml
LoD 2.4 µg/ml
LoQ 15.0 µg/ml | Lower detection level
(LDL) 0.7 µg/ml |
| Measuring range | 15-300 µg/ml | 0.7-300 µg/ml |
| Interferences | Bilirubin interference at
Acetaminophen level of 15,
30 and 50 µg/ml. | Bilirubin interference at
Acetaminophen level of
50µg/ml |
Table C – COBAS Integra 800
Conclusion The Acetaminophen assays are substantially equivalence to the following predicate devices: Roche COBAS Integra Acetaminophen assay (K991598), the Roche/Hitachi Acetaminophen assay (K013757) and the cobas c501 Acetaminophen assay (K060373). This submission included additional information on interference caused by bilirubin in order to help improve the safe and effective use of the products.
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Image /page/4/Picture/0 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 representation of a human figure, possibly symbolizing health and well-being.
10903 New Hampshire Avenue Silver Spring, MD 20993
Roche Diagnostics c/o Angelo Pereira 9115 Hague Road Indianapolis, IN 46250-0416
DEC 2 3 2011
Re: K110726
Trade Name: ROCHE ACETAMINOPHEN ASSAY Regulation Number: 21 CFR §862.3030 Regulation Name: Acetaminophen Test System Regulatory Class: Class II Product Codes: LDP Dated: December 7, 2011 Received: December 8, 2011
Dear Mr. Pereira:
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 Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
5
Page 2
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (301) 796-5760. For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/Medical
Devices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance ...
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm
Sincerely yours.
$
Counney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
6
Indications for Use
510(k) Number (if known):
Device Name: Roche Acetaminophen Assay
Indications For Use:
The Roche Acetaminophen assay is an in vitro test for the quantitative determination of toxic levels of acetaminophen in serum and plasma on Roche COBAS Integra, Roche/ Hitachi and cobas c system analyzers.
Prescription Use XXX
AND/OR
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K110726
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