For in vitro diagnostic use in the quantitative determination of acetaminophen in human serum and plasma (lithium heparin) on ADVIA Chemistry systems. Such measurements are used in the detection of acetaminophen overdose.

Device Description

Not Found

AI/ML Overview

This document is a 510(k) premarket notification decision letter from the FDA for the ADVIA® Chemistry Acetaminophen Reagent. It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the way a medical imaging AI device submission would.

Medical device submissions for invitro diagnostic devices like this one focus on demonstrating substantial equivalence to a predicate device, and performance is typically evaluated through analytical validation studies (e.g., accuracy, precision, linearity, interference) rather than clinical studies with "test sets," "ground truth," or "expert readers" as you might find for an imaging AI.

Therefore, I cannot extract the requested information from the provided text because it describes a different type of medical device and regulatory submission.

Specifically, the information you requested would not typically be found in this type of document:

A table of acceptance criteria and the reported device performance: This document is the FDA's decision letter, not the submission itself which would contain such tables. Furthermore, for IVD devices, these criteria relate to analytical performance characteristics rather than diagnostic performance metrics like sensitivity/specificity derived from expert readings.
Sample size used for the test set and the data provenance: Not applicable in the context of this document.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
Adjudication method for the test set: Not applicable.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The device is a reagent for an automated chemistry analyzer, not an AI algorithm in the sense of imaging analysis.
The type of ground truth used: For an acetaminophen assay, "ground truth" would generally be established by highly accurate reference methods or known spiked concentrations, not expert consensus or pathology in this context.
The sample size for the training set: Not applicable as it's not an AI/machine learning model in the typical sense that requires a "training set."
How the ground truth for the training set was established: Not applicable.

Summary

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the seal for the Department of Health & Human Services. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the top half of the circle. The bottom half of the circle contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES". In the center of the seal is an image of an eagle.

Siemens Healthcare Diagnostics, Inc. c/o Dr. Kira Gordon Regulatory Affairs and Compliance 511 Benedict Avenue Tarrytown, New York 10591

Food & Drug Administration 10903 New Hampshire Avenue Building 66 Silver Spring, MD 20993

AUG 4 2010

K100200 Re:

Trade name: ADVIA® Chemistry Acetaminophen Reagent Regulation Number: 21 CFR 862.3030 Regulation Name: Acetaminophen test system. Regulatory Class: Class II Product Code: LDP Dated: July 16, 2010 Received: July 19, 2010

Dear Dr. Gordon:

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).

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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/MedicalDevices/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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Courtney C. Harper, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K100200

Device Name:

AUG 0 4 2010

ADVIA® Chemistry Acetaminophen Reagent

Indications For Use:

ﯿﮯ Prescription Use _ (21 CFR Part 801 Subpart D) Over the Counter Use (21 CFR Part 801 Subpart C)

ﺮ ﺃﻣﺮ

(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)

And/Or

Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)

Signature

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety 510(k) K / OQ 200

Regulation Number and Section

§ 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.