The Bayer ADVIA IMS Acetaminophen method is an in vitro diagnostic device intended to measure acctaminophen levels in human serum or plasma (Lithium heparin). Such measurements are used in the diagnosis of acetaminophen toxicity and overdose.

Device Description

This in-vitro diagnostic method is intended to measure acetaminophen in human serum and plasma using lithium heparin as the anticoagulant on ADVIA® IMS™. Acetaminophen (Tylenol, paracetamol, p-hydroxyacetanilide) is used in many formulations as an analgesic, generally with no adverse effects. Measurement of acetaminophen is used in the diagnosis and treatment of severe liver damage caused by overdose through chronic usage, accident or self-infliction.

AI/ML Overview

Here's an analysis of the provided text to extract the acceptance criteria and study details:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state "acceptance criteria" in a formal, enumerated list. However, based on the performance data presented and the conclusion of equivalence to a predicate device, we can infer the implied acceptance criteria were met by showing comparable or better performance in the following areas:

Criteria Category	Implied Acceptance Criterion	Reported Device Performance (ADVIA IMS)
Imprecision (CV%)	CV% should be comparable to or better than the predicate device (Abbott/TDx) at similar levels.
Level 1.5 mg/dL	≤ 4.9% (Predicate device value)	2.6%
Level 5.0 mg/dL (approx)	≤ 3.0% (Predicate device 3.5 mg/dL)	1.5%
Level 14.9-15 mg/dL	≤ 3.9% (Predicate device 15 mg/dL)	1.3%
Correlation (Regression)	Strong correlation with the predicate device (Y=ADVIA IMS, X=comparison system) with an R-value close to 1 and a regression equation close to Y=X.
Serum (vs Abbott/TDx)	R-value close to 1, slope close to 1, intercept close to 0.	R=0.999, Y=1.05X - 0.25
Plasma (y) vs Serum (x) (within ADVIA IMS)	R-value close to 1, slope close to 1, intercept close to 0.	R=0.998, Y=1.00X + 0.05
Correlation (Syx)	Syx (standard error of the estimate) should be low, indicating good agreement.
Serum (vs Abbott/TDx)	Low value (e.g., <0.5 mg/dL)	0.31 mg/dL
Plasma (y) vs Serum (x)	Low value (e.g., <0.5 mg/dL)	0.32 mg/dL
Interference	Limited significant interference (e.g., % change < ±10-15%) from common substances.
Bilirubin (unconjugated)	<+15%	+9%
Bilirubin (conjugated)	<+15%	+4%
Hemoglobin	>-15%	-4%
Lipids (Triglycerides)	>-15%	-9%
Analytical Range	Sufficient range for clinical use (0-20 mg/dL).	0 to 20 mg/dL

2. Sample Sizes and Data Provenance

Test Set Sample Sizes:
- Imprecision (Serum): Not explicitly stated how many samples per level were used for CV calculation, but generally, this involves replicate measurements on multiple samples.
- Correlation (Serum vs Abbott/TDx): 46 specimens
- Correlation (Plasma vs Serum on ADVIA IMS): 50 specimens
- Interfering Substances: A single Acetaminophen concentration was tested for each interferent, but the number of unique samples is not specified.
Data Provenance: The document does not specify the country of origin of the data or whether the study was retrospective or prospective. It implies the studies were conducted by Bayer Corporation for regulatory submission.

3. Number of Experts and Qualifications for Ground Truth

This type of in-vitro diagnostic device (an assay for a chemical compound) typically does not rely on human experts to establish "ground truth" for the test set in the same way imaging devices do. The ground truth for such assays is established through:

Reference Methods: Highly accurate and precise analytical methods (e.g., GC-MS, HPLC) or certified reference materials are used to assign true values to samples.
Predicate Device Measurements: For comparison studies, the predicate device itself serves as a "ground truth" for the new device, assuming the predicate device is already validated and accepted.

The document does not mention any human experts or their qualifications for establishing ground truth.

4. Adjudication Method for the Test Set

Not applicable. As described in point 3, this device's performance evaluation does not involve subjective interpretations requiring adjudication by experts. The ground truth for quantitative assays is based on analytical measurements.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. This is an in-vitro diagnostic assay for measuring acetaminophen concentrations, not an imaging device or a device requiring human interpretation of results in a diagnostic imaging workflow. Therefore, an MRMC study is not relevant or performed for this type of device.

6. Standalone Performance

Yes, the studies presented (Imprecision, Correlation, Interfering Substances, Analytical Range) represent the standalone performance of the ADVIA IMS Acetaminophen method. The "Correlation" section specifically compares the new device's measurements (Y) against a known comparison system (X), which serves as a benchmark for its standalone accuracy.

7. Type of Ground Truth Used

The ground truth used for this device's evaluation is primarily comparison to a legally marketed predicate device (Abbott/TDx) and likely reference methods or certified materials for establishing the validity of the predicate device and the new device's calibration and analytical range. For the interference study, the "true" acetaminophen concentration would have been precisely known when the interfering substance was added.

8. Sample Size for the Training Set

The document does not provide information about a "training set" or its sample size. For an in-vitro diagnostic assay of this nature, the development process typically involves:

Method development and optimization.
Calibration using a set of calibrators (the calibrator part number 04919015 is mentioned).
Verification and validation studies using various types of samples to assess precision, accuracy, linearity, interference, etc.

There typically isn't a "training set" in the machine learning sense, as this is a chemical assay, not an AI/ML algorithm.

9. How the Ground Truth for the Training Set was Established

Not applicable, as there is no mention of a "training set" in the context of an AI/ML algorithm. The calibration process for the assay would establish its measurement curve, and this would be based on precisely known concentrations of acetaminophen.

Summary

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510(k) SUMMARY OF SAFETY AND EFFECTIVENESS Acetaminophen method for ADVIA® IMSTM

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of the Safe Medical Device Act of 1990 and 21 CFR 807.92.

The assigned 510(k) number is: KOZO 792

1. Intended Use

2. Predicate Device

Product Name		Calibrator-
Anhott/TTT	APA C COA	000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000002

3. Device / Method

Product Name	Reagent BAN	Calibrator BAN
Bayer ADVIA IMS	01352146	04919015

Imprecision (Serum)

ADVIA IMS
Level(mg/dL)	TotalCV(%)
1.5	2.6
5.0	1.5
14.9	1.3

Abbott/TDx
Level(mg/dL)	TotalCV(%)
1.5	4.9
3.5	3.0
15	3.9

Correlation (Y=ADVIA IMS, X=comparison system)

Specimen type	Comparison System (X)	N	Regression Equation	Syx (mg/dL)	R	Sample Range (mg/dL)
Serum	Abbott/TDx	46	$Y=1.05X - 0.25$	0.31	0.999	0.3-19.3
Plasma(y), Serum(x)	ADVIA IMS	50	$Y=1.00X + 0.05$	0.32	0.998	2.3-17.3

Interfering Substances

InterferingSubstance	Interfering Sub.Conc. (mg/dL)	Acetaminophen Conc(mg/dL)	Effect(% change)
Bilirubin (unconjugated)	25	5.7	+9
Bilirubin (conjugated)	25	5.7	+4
Hemoglobin	1000	5.5	-4
Lipids (Triglycerides)	500	5.6	-9

Analytical Range

Serum/Plasma: 0 to 20 mg/dL

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4. Conclusion

Performance of the ADVIA IMS Acetaminophen Assay on a Bayer ADVIA® IMS™ is equivalent to the performance of the Acetaminophen Assay on the predicate device (Abbott TDX, K840941) and is within proposed manufacturing specifications. No safety and effectiveness issues have been raised.

Kenneth M. Gibbs

2/28/02

Date

Kenpeth T. Edds Manager Regulatory Affairs Bayer Corporation 511 Benedict Avenue Tarrytown, New York 10591-5097

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Image /page/2/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in all caps and is in a serif font. The text is black and the background is white. There is a logo to the left of the text.

Food and Drug Administration 2098 Gaither Road. Rockville MD 20850

JUL 11 2002

Kenneth T. Edds, Ph.D. Regulatory Affairs Manager Bayer Corporation 511 Benedict Avenue Tarrytown, NY 10591-5097

K020792 Re:

Trade/Device Name: Acetaminophen Assay for the ADVIA® IMS™ Regulation Number: 21 CFR 862.3030 Regulation Name: Acetaminophen test system Regulatory Class: Class II Product Code: LDP Dated: June 19, 2002 Received: June 20, 2002

Dear Dr. Edds:

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 the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence 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 and ' additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrb/dsmamain.html".

Sincerely yours,

Steven Butman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory-Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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KO20792 510(k) Number:

Device Name: Acetaminophen Assay for the ADVIA® IMSTM

Indications for Use:

Jean Cooper
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K020792

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109) √

Over-The-CounterUse_

(Optional Format 1-2-96)

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.