OPUS Ethanol is an in vitro diagnostic thin film-based, fluorescence inhibition test for the quantitative measurement of ethanol in human serum or plasma as an aid in the diagnosis and treatment of alcohol intoxication and poisoning. OPUS Ethanol is intended for use with the OPUS analyzers.

Device Description

OPUS Ethanol is a set of in vitro diagnostic reagents intended to be used together with the OPUS immunoassay analyzers for the quantitative measurement of ethanol in human serum or plasma. Assay range is 10-300 mg/dl.

AI/ML Overview

Kanzoll Behring Diagnostics Inc. OPUS® Ethanol 510(k) Notification

Here's an analysis of the provided Kanzoll document, focusing on acceptance criteria and the study proving the device meets them:

Missing Information Disclaimer:

It's important to note that the provided document is a 510(k) summary, which often provides a high-level overview. Consequently, some details typically found in a full study report (like acceptance criteria for precision and accuracy, detailed ground truth establishment for training, or explicit statements about standalone performance and MRMC studies) may not be explicitly stated or fully detailed. In such cases, I will infer based on common medical device submission practices or mark as "Not explicitly stated."

1. Table of Acceptance Criteria and Reported Device Performance

Note: Acceptance criteria for precision and accuracy are not explicitly stated in the provided summary. The reported performance is presented as the study result.

Performance Characteristic	Acceptance Criteria (Not explicitly stated in document)	Reported Device Performance
Precision
Intra-assay %CV	(e.g., ≤ 10% for clinical assays)	5.1% to 8.7%
Inter-assay %CV	(e.g., ≤ 10% for clinical assays)	4.97% to 8.73%
Accuracy (Recovery)	(e.g., 90-110% recovery)	92% to 113%
Accuracy (Correlation)	(e.g., r ≥ 0.95, specific slope/intercept range)	r = 0.995, y-intercept = 5.05, slope = 0.89

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

Sample Size for Precision:
- Intra-assay: 3 levels of control material, 20 replicates each. (Total 60 measurements)
- Inter-assay: 3 levels of control material, duplicate measurements over 5 days. (Total 30 measurements)
Sample Size for Accuracy (Recovery): 4 dilutions of an elevated patient sample, assayed in duplicate. (Total 8 measurements)
Sample Size for Accuracy (Correlation): 50 serum samples.
Data Provenance: Not explicitly stated (e.g., specific country, demographic details). "Normal human serum poor" and "elevated Bone AP patient sample" are mentioned, suggesting human biological samples. The study appears to be retrospective as it's testing pre-existing samples or control materials.

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

Not Applicable. This is an in vitro diagnostic (IVD) device for quantitative measurement of ethanol. The "ground truth" for such devices is typically established through analytical methods with known concentrations (e.g., spiked samples, reference materials, or a legally marketed predicate device). It does not involve expert readers establishing ground truth as in imaging or diagnostic pathology AI.
The "ground truth" for the correlation study was established by comparing to a "commercially available immunoassay" (the Abbott TDx/TDxFLx REA Ethanol assay, as implied by the substantial equivalence claim).

4. Adjudication Method for the Test Set

Not Applicable. As an IVD device measuring a chemical analyte, expert adjudication methods (like 2+1 or 3+1) are not relevant here. The comparison is against established analytical methods/predicate devices.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

Not Applicable.
- The OPUS Ethanol device is a laboratory instrument/reagent system for quantitative measurement. It does not involve human "readers" interpreting images or clinical data in the same way an AI-powered diagnostic imaging tool would. Therefore, an MRMC study is not relevant to its evaluation.
- The study focuses on the analytical performance characteristics of the device itself (precision, accuracy) when processing samples.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, this is a standalone study.
- The performance characteristics (precision, recovery, correlation) reported are for the OPUS Ethanol system operating independently. There is no mention of human-in-the-loop assistance influencing the reported measurements. The device provides a quantitative measurement directly.

7. The Type of Ground Truth Used

For Precision: Based on control materials with established (or internally validated) target ethanol concentrations.
For Accuracy (Recovery): Created by dilutions of an elevated patient sample into a normal human serum pool. This implies a known expected concentration after dilution.
For Accuracy (Correlation): Measurements from a legally marketed predicate device, the Abbott TDx/TDxFLx REA Ethanol assay. This is a common method for IVD studies to demonstrate substantial equivalence.

8. The Sample Size for the Training Set

Not applicable / Not explicitly stated for 'training'.
- The OPUS Ethanol device is an immunoassay system, not an AI/Machine Learning algorithm that requires a "training set" in the conventional sense. It relies on chemical reactions and optical detection, not a learned model from a dataset.
- Therefore, the concept of a training set as understood in AI/ML is not relevant here. The manufacturing and calibration process of the reagents and instrument would be analogous to "training" in a broad sense, but not with a separate data set as described for AI.

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

Not Applicable. (See explanation in point 8).
- The "ground truth" for the calibration of the instrument would be established through a six-level calibrator system (as mentioned in point 6, comparing it to the predicate). These calibrators are solutions with precisely known concentrations of ethanol, used to create a standard curve.

Summary

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Kanzoll

Behring Diagnostics Inc. OPUS® Ethanol 510(k) Notification

JUL 2 2 1997

0000033

Summary for 510(k) OPUS Ethanol

Manufactures Name, Address, Telephone, and contact person, date of 1 . preparation :
Manufacturer:

Behring Diagnostics Inc. 151 University Avenue Westwood, MA 02090 617-320-3117 Attn .: Ruth Forstadt

Preparation date: May 29, 1997

1. Device Name/ Classification:
  OPUS Ethanol:

Alcohol Test System

Classification Number: Class II (862.3040)

3 . Identification of the legally marketed device:
Abbott TDx/TDxFLx REA Ethanol assay (K871645).

4 . Device Description:

5 . Device Intended Use:

CONFIDENTIAL

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Medical device to which equivalence is claimed and comparison 6. information:

The OPUS Ethanol assay is substantially equivalent in intended use to results obtained using the Abbott TDx/TDxFlx REA Ethanol assay. The Abbott TDx/TDxFlx REA Ethanol assay, like the proposed product, are based on a six level calibrator system. Both use the enzymes alcohol dehydrogenase and diaphorase to produce a formazan dye.

The OPUS Ethanol differs from the Abbott TDx/TDxFlx REA Ethanol assay in the technologies used. In the Abbott TDxTDxFlx REA Ethanol assay, an REA method is used, while a thin film-based fluorescence inhibition technology is used in the OPUS Ethanol test. Human whole blood, serum, plasma or urine can be tested with the Abbott TDx/TDxFlx REA Ethanol assay, but only human serum or plasma in the OPUS Ethanol test. Also, the Abbott TDx/TDxFlx REA Ethanol include tri-level controls for whole blood and serum, whereas the OPUS Ethanol test does not include controls. Additionally, because of the volatile nature of ethanol, the Abbott TDx/TDxFlx REA Ethanol assay, in its liquid format, can run no more than 12 samples at a time, while the OPUS Ethanol assay because of its solid format, is not limited in this way by sample volatility.

7 . Device Performance Characteristics:

Precision

Intra-assay precision was determined by the evaluation of three levels of control material in replicates of twenty (20) each. %CV ranged from 5.1% to 8.7%.

Inter-assay precision was determined by the evaluation of three levels of control material in duplicate, assayed over a five day period to total 20 replicates. %CV ranged from 4.97% to 8.73%.

Accuracy by Recovery

Recovery was determined by making four dilutions of an elevated Bone AP patient sample into a normal human serum pool. The samples were assayed using OPUS Ethanol in duplicate. Percent recovery ranged from 92% to 113%

Accuracy by Correlation

OPUS Ethanol was compared to a commercially available immunoassay by evaluation of 50 serum samples ranging from 24.65 to 278.50 mg/dl. A correlation coefficient of 0.995 was obtained with a y-intercept value of 5.05 and a slope of 0.89.

16:00 : 3

CONFIDENTIAL

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ruth Forstadt · Requlatory Affairs Associate Behring Diagnostics 151 University Avenue Westwood, Massachusetts 02090

K972011 Re : OPUS® Ethanol Test System Regulatory Class: II Product Code: DIC Dated: May 29, 1997 Received: May 30, 1997

Dear Ms. Forstadt:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), 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 895. ਜ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (OS) for Medical General regulation (21 CFR Part 820) and that, Devices: through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlationy action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal Laws or Requlations.

JUL 22 1997

Image /page/2/Picture/9 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines forming its body and a curved line representing its legs. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter.

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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.

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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,
Steven Gutman

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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Behring Diagnostics Inc. OPUS® Ethanol 510(k) Notification

of Page .

510(k) Number (if known):

Device Name:_

OPUS Ethanol Test System

Indications For Use:

11/14 124 1

(Division Sign-Off)
Division of Clinical Laborator Devices
510(k) Number. K972011

(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 Counter Use

(Optional Format 1-2-96) 000019

ONFIDEN

Regulation Number and Section

§ 862.3040 Alcohol test system.

(a)
Identification. An alcohol test system is a device intented to measure alcohol (e.g., ethanol, methanol, isopropanol, etc.) in human body fluids (e.g., serum, whole blood, and urine). Measurements obtained by this device are used in the diagnosis and treatment of alcohol intoxication and poisoning.(b)
Classification. Class II.