For the quantitative measurement of acetaminophen in serum and plasma. Measurement of acetaminophen is used in the diagnosis and treatment of acetaminophen overdose toxicity.

Device Description

For the quantitative measurement of acetaminophen in serum and plasma. Measurement of acetaminophen is used in the diagnosis and treatment of acetaminophen overdose toxicity. Excessive amounts of acetaminophen leads to hepatotoxicity and nephrotoxicity. In acute overdosage, acetaminophen can cause severe hepatic damage leading to hepatic failure if untreated. Reagent is a two-part liquid in plastic bottles packaged in the appropriate box.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study details for the Acetaminophen L3K® Assay, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

Performance Metric	Acceptance Criteria (Implied)	Reported Device Performance
Serum Method Comparison	Strong correlation (e.g., correlation coefficient approaching 1), and a regression equation demonstrating close agreement with the predicate method (slope near 1, intercept near 0).	Correlation Coefficient: 0.9999 (between Acetaminophen L3K® Assay and a similar acetaminophen method) Deming Regression Equation: This method = 1.060 (reference method) + 4.6 µmol/L Confidence Interval: 95% Scatter around regression line: 8.9
Plasma Method Comparison	Strong correlation (e.g., correlation coefficient approaching 1), and a regression equation demonstrating close agreement between serum and plasma measurements of the new device (slope near 1, intercept near 0).	Correlation Coefficient: 0.9999 (between serum and plasma measurements of Acetaminophen L3K® Assay) Linear Regression Equation: This method (plasma) = 0.999 [This method (serum)] -2.2 µmol/L

Note: The acceptance criteria are "implied" because the document states "Testing results demonstrate that the Acetaminophen L3K® Assay is equivalent to the predicate device" and focuses on the high correlation coefficients and favorable regression results as proof of this equivalence, rather than explicitly listing numerical thresholds for acceptance. The core of the acceptance criteria for a 510(k) often revolves around demonstrating substantial equivalence to a predicate device, meaning the new device is as safe and effective as a legally marketed device.

2. Sample Size Used for the Test Set and Data Provenance

Serum Test Set Sample Size: 100 samples
Plasma Test Set Sample Size: 25 samples
Data Provenance: Not explicitly stated regarding the country of origin. The submission is from Genzyme Diagnostics P.E.I. Inc. in Canada, so it's likely the data originated there or in a region where they conducted their studies. The data is retrospective as it involves comparing the new device's measurements against an existing "reference method" (presumably the predicate device or a clinical laboratory's established method).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

This information is not provided in the given document. For an in vitro diagnostic (IVD) like this, "ground truth" would typically be established by comparing the device's results to a recognized reference method or a method already validated for clinical use, rather than expert consensus on individual cases. The "reference method" is the de facto "ground truth" here.

4. Adjudication Method for the Test Set

This information is not applicable for this type of IVD performance study. Adjudication methods (like 2+1, 3+1) are typically used in imaging studies or clinical trials where human interpretation or endpoint determination requires consensus among multiple experts. For a quantitative assay, the comparison is directly numerical against a reference method.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No, this was not done. The Acetaminophen L3K® Assay is an in vitro diagnostic device for quantitative measurement, not an AI-assisted diagnostic imaging or interpretation tool. Therefore, MRMC studies and concepts of human reader improvement with AI assistance are not relevant to this submission.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done

Yes, this was a standalone performance study. The Acetaminophen L3K® Assay is a laboratory assay that produces quantitative results directly. Its performance was evaluated purely on its analytical capabilities (accuracy, correlation) when measuring acetaminophen in samples, without any human-in-the-loop interpretation beyond standard laboratory procedures and result reporting.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The ground truth was established by a "similar acetaminophen method" referred to as the "reference method" in the serum comparison and the "This method (serum)" in the plasma comparison. This implies an existing, validated laboratory method. For IVDs, this is often a widely accepted and validated analytical method or the predicate device itself.

8. The sample size for the training set

This information is not provided as this is not an AI/ML device that requires a distinct "training set" in the conventional sense. The studies described are validation (test) studies to demonstrate performance. The "training" for such an assay would be its initial development and optimization, which isn't typically detailed in a 510(k) summary for a chemical assay.

9. How the ground truth for the training set was established

This information is not applicable as there is no mention of a "training set" in the context of an AI/ML device. For the development of the assay, standard analytical chemistry principles, method development, and optimization techniques would have been employed to ensure accuracy, but this is distinct from establishing ground truth for machine learning.

Summary

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K081938

MAY

1 2009

Acetaminophen L3K® Assay

Product Cat. No. 506-10 & 506-30

510(K) SUMMARY

Introduction: This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

Genzyme Diagnostics P.E.I. Inc. Submitter: 70 Watts Avenue Charlottetown, P.E.I. Canada C1E 2B9 (Tel:) (902)566-1396 (Fax:) (902)628-6504

Contact Person: Penny White

Date Prepared: June 1, 2008

Acetaminophen L3K® Assay Device Name: Tradename: FDA Regulation Name: 862.3030 Colorimetry, Acetaminophen FDA Product Code: LDP

Predicate Device: Genzyme Diagnostics P.E.I. Inc. (K042330)

Device Description: For the quantitative measurement of acetaminophen in serum and plasma. Measurement of acetaminophen is used in the diagnosis and treatment of acetaminophen overdose toxicity. Excessive amounts of acetaminophen leads to hepatotoxicity and nephrotoxicity. In acute overdosage, acetaminophen can cause severe hepatic damage leading to hepatic failure if untreated.

Reagent is a two-part liquid in plastic bottles packaged in the appropriate box.

Intended Use For the quantitative measurement of acetaminophen in serum and plasma. Measurement of acctaminophen is used in the diagnosis and treatment of scycre liver damage caused by overdose toxicity. Excessive amounts of acetaminophen leads to hepatotoxicity and nephrotoxicity. In acute overdosage, acetaminophen can cause severe hepatic damage leading to hepatic failure if untreated. For IN VITRO diagnostic use.

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Comparison to Predicate Device:

Description of the Item Being Compared:

For the In Vitro quantitative measurement

Acetaminophen Enzyme Reagent (R1): buffer (pH 8.6 at 25 ℃ ) 0.2 mmol/L MnCl2 . 4H2O, ≥ 0.9 KU/L Acyl Amidohydrolase, surfactant, preservatives.

Acetaminophen Color Reagent (R2): 0.1 mol/L sodium carbonate buffer (pH 12.2 at 25 ℃ ), 30 mmol/L 8-hydroxyquinolinc-5-sulfonic acid, surfactant, preservatives.

Acetaminophen Standard: buffer (pH 5.0 at 25 ℃ ), 1000μmol/L (15.1 mg/dL) acetaminophen, preservatives.

Similaries:

The submission device and the predicate device have the same intended use.

The submission device and the predicate device both use Aryl Acylamidase enzyme method in acetaminophen measurement.

The submission device and the predicate device have the same oxidative coupling method.

Differences:

The predicate device uses a different chromophore in the oxidative coupling reaction during color development.

The predicate devices uses 8 hydroxyquinoline and the submission device uses 2,5 dimethylphenol.

Comments on Substantial Equivalence:

Testing results demonstrate that the Acetaminophen L3K® Assay is equivalent to the predicate device. Method comparison results provided the following:

Serum

Deming regression using NCCLS EP9-A2.

A comparison was made between this method and a similar acetaminophen method using 100 samples in serum ranging from 26 to 2361 @mol/L. The correlation coefficient was 0.9999. Deming regression analysis gave the following equation:

This method = 1.060(reference method) + 4.6 @mol/L

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Confidence interval is 95%. Correlation coefficient is 0.9999. The amount of scatter around the estimate regression line is 8.9. The approach is not different from the predicate device.

Plasma

A comparison was made between serum and plasma using 25 samples ranging from 30 to 2441 umol/L. The correlation coefficient was 0.9999. Linear regression analysis gave the following equation:

This method (plasma) = 0.999 [This method (serum)] -2.2 umol/L

Genzyme Diagnostics P.E.I. Inc. Acetaminophen L3K® Assay is Conclusion: substantially cquivalent in principle and performance to the predicate product.

Penny White Regulatory Affairs Coordinator Genzyme Diagnostics P.E.I. Inc.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.

Public Health Service

MAY - 1 2009

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Genzyme Diagnostics P.E.I. Inc. c/o Ms. Penny J. White Regulatory Affairs Coordinate 70 Watts Avenue Charlottetown, Prince Edward Island Canada C1E 2B9

Re: K081938

Trade/Device Name: Acetaminophen L3K Assay Regulation Number: 21 CFR 862.3030 Regulation Name: Acetaminophen test system Regulatory Class: Class II Product Code: LDP Dated: April 8, 2009 Received: April 27, 2009

Dear Ms. White:

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 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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Page - 2

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial cquivalence of your device to a legally marketed predicate 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), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0450. 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 (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

A.C.H

Courtney C. Harper, Ph.D. Acting 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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Indication for Use

510(k) Number (if known): K081938

Device Name: Acetaminophen L3K Assay

Indication For Use:

For the quantitative measurement of acetaminophen in serum and plasma. Measurement of acetaminophen is used in the diagnosis and treatment of acetaminophen overdose toxicity.

Prescription Use X (21 CFR Part 801 Subpart D) And/Or

Over the Counter Use (21 CFR Part 801 Subpart C)

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

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

Lucy Phillips

Office of In Vitro Diagnostic Device Evaluation and Safety

4081938 510(k)

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.