(35 days)
The ACTM FLEX™ reagent cartridge used on the Dimension® clinical chemistry system is an in vitro diagnostic test intended to measure the drug acetaminophen in plasma and serum. Measurements obtained by this device are used in the diagnosis and treatment of acetaminophen overdose.
The ACTM method is based on the enzymatic hydrolysis of acetaminophen producing acetate and p-aminophenol. The amount of p-aminophenol is measured colorimetrically and is proportional to the acetaminophen concentration.
Here's an analysis of the provided K963244 document based on your request, focusing on acceptance criteria and supporting study details:
Device: Acetaminophen FLEX™ Reagent Cartridge
This document describes a submission for a reagent cartridge for an in vitro diagnostic test, not an AI-powered medical device. As such, many of the requested fields related to AI, such as "multi-reader multi-case comparative effectiveness study," "human-in-the-loop performance," "number of experts," and "adjudication method," are not applicable to this type of submission. The ground truth in this context typically refers to the reference method (the predicate device) or a gold standard chemical analysis, rather than expert consensus on images.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Device: | |
| - Correlation to aca® acetaminophen test pack | Correlation coefficient = 0.998 |
| - Agreement in measurement (slope and intercept relative to predicate) | Slope = 1.04 |
| Intercept = -3.27 | |
| - Analytical range of detection | Range of samples tested = 10.2 - 295.0 µg/mL |
Note: The document does not explicitly state numerical acceptance criteria (e.g., "correlation coefficient must be ≥ 0.98"). Instead, it presents the results of a comparison study to a legally marketed predicate device (aca® acetaminophen test pack) to demonstrate substantial equivalence, which is the implicit acceptance criterion for 510(k) submissions. The reported values (slope, intercept, correlation coefficient) are strong indicators of analytical agreement between the new device and the predicate.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: 154 serum or plasma samples.
- Data Provenance:
- Country of Origin: Not specified. (Typically assumed to be from within the country of the submitting company, in this case, the USA, but not explicitly stated).
- Retrospective or Prospective: Not specified. However, the nature of comparing sample results between two methods usually implies a prospective collection of samples analyzed by both, or retrospective analysis of banked samples. No information is given to definitively classify it.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
Not Applicable. For an in vitro diagnostic reagent, the "ground truth" for analytical performance studies is typically established by:
- Comparison to a legally marketed predicate device (as in this case).
- Reference methods (e.g., GC-MS, HPLC).
- Known concentration standards.
Expert interpretation (e.g., by radiologists) is not relevant for this type of device.
4. Adjudication Method for the Test Set
Not Applicable. Adjudication methods (like 2+1, 3+1) are used for resolving discrepancies in human expert interpretations, especially in image analysis studies. This is not relevant for an in vitro diagnostic analytical comparison.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. An MRMC study is not relevant for an in vitro diagnostic reagent.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
Yes (in principle, but framed differently). The study explicitly describes the performance of the "ACTM FLEX™ reagent cartridge on the Dimension® system" in measuring acetaminophen, independent of human interpretive steps beyond initial sample loading and result readout. The device itself (reagent + instrument) performs the measurement automatically. There is no human "in the loop" for interpreting the measurement result itself, though human clinicians use the result for diagnosis and treatment.
7. The Type of Ground Truth Used
The primary ground truth used was comparison to a legally marketed and FDA-cleared predicate device: the "aca® acetaminophen test pack on the aca® discrete clinical analyzer." This establishes "substantial equivalence" as the basis for clearance.
8. The Sample Size for the Training Set
Not Applicable. This document describes a traditional in vitro diagnostic device, not an AI/Machine Learning model. Therefore, there is no "training set" in the AI sense. The methods are based on established enzymatic reactions and colorimetric detection, not on learning from data.
9. How the Ground Truth for the Training Set Was Established
Not Applicable. As there is no training set for an AI model, this question is irrelevant. The chemical principles are inherent to the reagent's design.
§ 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.