The Roche ONLINE Gentamicin assay contains an in vitro diagnostic reagent system indicated for the quantitative determination of gentamicin, an antibiotic drug, in human serum or plasma on automated clinical chemistry analyzers. Measurements obtained by the device are used in the diagnosis and treatment of gentamicin overdose and in monitoring levels of gentamicin to ensure appropriate therapy.

Device Description

AI/ML Overview

The Roche ONLINE Gentamicin Assay is an in vitro diagnostic reagent system designed for the quantitative determination of gentamicin in human serum or plasma on automated clinical chemistry analyzers. The device is used to diagnose and treat gentamicin overdose and monitor drug levels for appropriate therapy.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state acceptance criteria in a formal table with pass/fail thresholds. Instead, it presents performance characteristics (precision and method comparison) of the new device and compares them to a legally marketed predicate device (COBAS INTEGRA Gentamicin Assay). The statement "All of the evaluation studies gave acceptable results compared to the predicate device" implies that the new device's performance characteristics were deemed equivalent to those of the predicate.

Below is a table summarizing the reported device performance, with the implicit acceptance criteria being performance comparable to the predicate device.

Performance Metric	Roche ONLINE Gentamicin (New Device)	Predicate Device (COBAS INTEGRA Gentamicin)	Implicit Acceptance Criteria
Method Comparison (Roche/Hitachi 917 vs. COBAS INTEGRA 700)
N	112	145	Comparable correlation (R) and slope (Y)
Equation (Y = mx + b)	Y = 1.104x - 0.022	Y = 1.025x - 0.029
Correlation Coefficient (R)	0.984	0.998
Range (µg/mL)	0.17 to 7.81	0.5 to 10.0
Precision (Level 1)
Mean (µg/mL)	3.36	1.4	Comparable CV% (within run & total)
CV% (within run)	1.0	3.0
CV% (total)	2.9	3.4
Precision (Level 2)
Mean (µg/mL)	6.26	4.0	Comparable CV% (within run & total)
CV% (within run)	0.9	1.9
CV% (total)	3.2	1.8
Precision (Level 3)
Mean (µg/mL)	7.96	4.9	Comparable CV% (within run & total)
CV% (within run)	0.7	2.1
CV% (total)	2.7	2.1

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

Sample Size for Test Set:
- For the method comparison study comparing the Roche/Hitachi 917 to the COBAS INTEGRA 700 (new device vs. predicate), the sample size was N = 112.
- For the comparison of the predicate device (COBAS INTEBRA Gentamicin) to COBAS FARA II Gentamicin assay, the sample size was N = 145. This appears to be a historical comparison for the predicate, not directly reflecting the current test set for the new device.
Data Provenance: The document does not specify the country of origin of the data or whether the data was retrospective or prospective. It is implied to be data collected specifically for this 510(k) submission, likely prospective, given the nature of performance evaluation studies for new devices.

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

This type of information is not applicable to this device. The Roche ONLINE Gentamicin Assay is an in vitro diagnostic device that quantifies a drug concentration in biological samples. The "ground truth" for its performance is established by comparison to a reference method or a legally marketed predicate device, and through analytical performance characteristics like precision, not by expert interpretation of images or clinical outcomes.

4. Adjudication Method for the Test Set

This is not applicable to this device. Adjudication methods (e.g., 2+1, 3+1) are typically used in studies where human readers interpret data, and discrepancies need to be resolved. This device performs a quantitative chemical analysis, not interpretation.

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

This is not applicable to this device. MRMC studies are relevant for AI-powered diagnostic tools that assist human readers in tasks like image interpretation. The Roche ONLINE Gentamicin Assay is a laboratory assay for drug concentration measurement and does not involve human readers for interpretation in this context, nor does it use AI.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, a standalone performance study was conducted. The entire evaluation, including method comparison and precision, assesses the performance of the device (reagent system on an automated analyzer) without human intervention in the analytical process itself. The numbers reported (e.g., correlation coefficient, CV%) directly reflect the algorithm/assay's performance.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance evaluation was established by:

Comparison to a Legally Marketed Predicate Device: The Roche ONLINE Gentamicin Assay was compared to the COBAS INTEGRA Gentamicin Assay, which serves as a recognized standard in the market. The predicate's results are considered the comparative "truth" or reference.
Analytical Performance Metrics: Intrinsic analytical performance characteristics such as precision (within-run and total CV%) are fundamental to establishing the reliability and "truthfulness" of the measurements.

8. The Sample Size for the Training Set

This is not applicable to this device in the context of an AI/machine learning training set. The Roche ONLINE Gentamicin Assay is a chemical assay, not an AI or machine learning algorithm that requires a "training set." Its calibration involves calibrator materials with known concentrations, but this is a standard chemical assay procedure, not an AI training process.

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

This is not applicable for the same reasons as point 8. The "ground truth" for calibration in a chemical assay is established through the gravimetric preparation of calibrators with certified concentrations or by comparison to definitive reference methods.

Summary

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KC020704

JUL 12 2002

Roche ONLINE Gentamicin Assay

510(k) Summary

Introduction	According to the requirements of 21 CFR 807.92, the following information provides sufficient detail to understand the basis for a determination of substantial equivalence.
1) Submitter name, address, contact	Roche Diagnostics Corporation9115 Hague Rd.Indianapolis, IN 46250(317) 845-2000Contact Person: Mike FlisDate Prepared: Februray 27, 2002
2) Device name	Roche ONLINE Gentamicin
3) Predicate device	We claim substantial equivalence to the COBAS INTEGRA Gentamicin Assay.
4) Device Description	The Roche ONLINE Gentamicin assay contains an in vitro diagnostic reagent system indicated for the quantitative determination of gentamicin, an antibiotic drug, in human serum or plasma on automated clinical chemistry analyzers. Measurements obtained by the device are used in the diagnosis and treatment of gentamicin overdose and in monitoring levels of gentamicin to ensure appropriate therapy. The proposed labeling indicates the Roche/Hitachi 911, 912, 917, and Modular P analyzers can be used with the Roche ONLINE Gentamicin reagent kits.

Continued on next page

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510(k) Summary, Continued

comparison results.

1 - 12

5) Intended use	For the quantitative determination of gentamicin in human serum or plasma on automated clinical chemistry analyzers.
6) Comparison to predicate device	The Roche ONLINE Gentamicin was evaluated for several performance characteristics, including precision, lower detection limit, method comparison, specificity, and interfering substances. All of the evaluation studies gave acceptable results compared to the predicate device. These experiments provide evidence that the Roche ONLINE Gentamicin Assay is substantially equivalent to the currently marketed Roche COBAS INTEGRA

5) Intended use

For the quantitative determination of gentamicin in human serum or plasma on automated clinical chemistry analyzers.

6) Comparison to predicate device

The Roche ONLINE Gentamicin was evaluated for several performance characteristics, including precision, lower detection limit, method comparison, specificity, and interfering substances. All of the evaluation studies gave acceptable results compared to the predicate device. These experiments provide evidence that the Roche ONLINE Gentamicin Assay is substantially equivalent to the currently marketed Roche COBAS INTEGRA

Roche ONLINE Gentamicin				Roche COBAS INTEGRA Gentamicin,(Predicate)
Roche/Hitachi 917 versus Gentamicin assay onthe COBAS INTEGRA 700				Versus COBAS FARA II Gentamicinassay
N = 112				N= 145
Y = $1.104x - 0.022$				Y = $1.025x - 0.029$
R = 0.984				R = 0.998
Range = 0.17 to 7.81 µg/mL				Range = 0.5 to 10.0 µg/mL
Precision:	Level 1	Level 2	Level 3	Level 1	Level 2	Level 3
Mean (µg/mL)	3.36	6.26	7.96	1.4	4.0	4.9
CV% (within run)	1.0	0.9	0.7	3.0	1.9	2.1
CV% (total)	2.9	3.2	2.7	3.4	1.8	2.1

Gentamicin Assay. The following table presents the precision and method
comparison results.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/2 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features an abstract eagle design with three curved lines representing the eagle's head and wings. The seal is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.

.JUI 12 2002

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mr. Mike Flis Regulatory Affairs Principle 9115 Hague Road P.O. Box 50457 Indianapolis, IN 46250-0457

K020704 Re:

Trade/Device Name: Roche ONLINE Gentamicin Assay Regulation Number; 21 CFR 862.3450 Regulation Name: Gentamicin test system Regulatory Class: Class II Product Code: LCD Dated: June 7, 2002 Received: June 10, 2002

Dear Mr. Flis:

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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Page 2 -

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/cdrh/dsma/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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Roche Diagnostics Corporation

510(k) Number (if known): Device Name: Roche ONLINE Gentamicin Assay Indications for Use:

eom

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K020704

(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) $\checkmark$

Over-The-Counter Use

(Optional Format 1-2-96)

Regulation Number and Section

§ 862.3450 Gentamicin test system.

(a)
Identification. A gentamicin test system is a device intended to measure gentamicin, an antibiotic drug, in human specimens. Measurements obtained by this device are used in the diagnosis and treatment of gentamicin overdose and in monitoring levels of gentamicin to ensure appropriate therapy.(b)
Classification. Class II.