LogoFDA 510(k) Search
K Number
K100200
Device Name
ADVIA CHEMISTRY ACETAMINOPHEN REAGENT, MODEL REF 07989138
Manufacturer
SIEMENS HEALTHCARE DIAGNOSTICS
Date Cleared
2010-08-02

(189 days)

Product Code
LDP
Regulation Number
862.3030
Type
Traditional
Panel
TX
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

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:

  1. 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.
  2. Sample size used for the test set and the data provenance: Not applicable in the context of this document.
  3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
  4. Adjudication method for the test set: Not applicable.
  5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable.
  6. 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.
  7. 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.
  8. 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."
  9. How the ground truth for the training set was established: Not applicable.

§ 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.