The Roche Diagnostics, Boehringer Mannheim Chemstrip 101 Urine Analyzer is a reflectance photometer for in-vitro semi-quantitative determination of the following urine analytes: specific gravity, pH, leukocytes, nitrite, glucose, ketones, urobilinogen, bilirubin and blood.

According to the Code of Federal Regulations, Title 21 (Food and Drugs), Part 862.2900, an automated urinalysis system is a device intended to measure certain of the physical properties and chemical constituents of urine by procedures that duplicate manual urinalysis systems. This device is used in conjunction with certain materials to measure a variety of urinary analytes.

Device Description

The Chemstrip 101 Urine Analyzer is a reflectance photometer intended for in-vitro semi-quantitative reading of Chemstrip 10 UA urine test strips for the following analytes: specific gravity, pH, leukocytes, nitrite, protein, glucose, ketones, urobilinogen, bilirubin and blood.

The modifications which have been incorporated into the Chemstrip 101 Urine Analyzer are:
1.) an additional calibration fail-safe mechanism;
2.) an automated test strip holder;
3.) a rotating reader head, and
4.) increased results memory capacity

AI/ML Overview

This document is a 510(k) summary for the Chemstrip 101 Urine Analyzer by Boehringer Mannheim Corporation (doing business as Roche Diagnostics). This device is an automated urinalysis system intended for in-vitro semi-quantitative reading of Chemstrip 10 UA urine test strips.

1. Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not explicitly state acceptance criteria in the form of specific performance metrics (e.g., accuracy percentages, precision ranges) for the Chemstrip 101 Urine Analyzer. Instead, the basis for substantial equivalence is primarily focused on similarity to a predicate device (Chemstrip Mini UA Urine Analyzer) and the safety/effectiveness of modifications.

The document highlights the following performance aspects through comparison to the predicate:

Acceptance Criteria/Performance Aspect	Chemstrip 101 Urine Analyzer Reported Performance	Predicate Device (Chemstrip Mini UA Urine Analyzer) Performance	Comments
Intended Use	In-vitro semi-quantitative determination of urine analytes	Same	Identical intended use, implying similar performance expectations for detecting analytes.
Scientific Technology	Reflectance Photometer	Same	Uses the same core principle for reading test strips.
Urine Test Strips	For use with Chemstrip 10 UA test strips	Same	Compatible with the same test strips, suggesting consistency in chemical reactions.
Test Parameters	Specific gravity, pH, leukocytes, nitrite, protein, glucose, ketones, urobilinogen, bilirubin and blood.	Same	Measures the same panel of analytes, implying identical analytical capabilities.
Calibration Fail-Safe	Enhanced fail-safe mechanism: Prevents tests after weekly calibration limit until calibration is performed.	"Repeat Calibration" message displayed, but no lock-out mechanism.	Improved safety feature; prevents use of un-calibrated device.
Automated Test Strip Tray	Motor-driven, automatically positions strip for measurement.	Manual test strip tray.	Automation for user convenience and potentially improved consistency in strip placement.
Reader Head	One rotating reader head.	11 fixed-position LEDs.	A design change optimizing the reading process due to automated strip movement while maintaining the same light source and technology.
Results Memory Capacity	Stores up to 100 sample results, with reprint option.	Did not have memory capability.	Enhanced functionality for data management.

Summary of Acceptance Criteria and Performance: The acceptance criteria for the Chemstrip 101 appear to be based on demonstrating substantial equivalence to the predicate device in terms of intended use, scientific technology, and tested parameters, with additional safety and usability enhancements that do not negatively impact fundamental performance. The study described focuses on comparing the new device's features and functionalities against a previously cleared device. There are no explicit quantitative performance criteria (e.g., accuracy, precision studies) provided in this summary. The implicit acceptance is that the modifications do not degrade the analytical performance compared to the predicate and that the added features are effective and safe.

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

The provided 510(k) summary does not contain information about a specific test set sample size or data provenance (e.g., country of origin, retrospective/prospective). The document describes the device and its modifications, and then asserts substantial equivalence to a predicate. It discusses the functional differences and improvements, but not a clinical or performance study with a distinct test dataset.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not provided in the 510(k) summary. Since no clinical or performance study with a defined test set and ground truth is described, there's no mention of experts or their qualifications for establishing ground truth.

4. Adjudication Method

This information is not provided in the 510(k) summary. As no clinical or performance study involving human interpretation or uncertain cases is detailed, an adjudication method is not applicable in this context.

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

A Multi Reader Multi Case (MRMC) comparative effectiveness study was not described or done based on the provided summary. This type of study would typically involve human readers interpreting results with and without AI assistance to measure effect size, which is not relevant for an automated urinalysis system.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

A standalone performance study focused on the algorithm only (without human-in-the-loop performance) was not explicitly described in the provided summary. The document focuses on demonstrating that the device, with its automated features, functions comparably to the predicate device in terms of its ability to read test strips. Detailed analytical performance data (e.g., accuracy, precision against a reference method) are not included in this summary, which would typically be part of a standalone study for an analytical measurement device.

7. Type of Ground Truth Used

The provided 510(k) summary does not specify the type of ground truth used because it does not detail a performance study that required establishing ground truth for evaluating the device's analytical accuracy. The focus is on the device's functional equivalence and safety of modifications compared to a predicate. For an in-vitro diagnostic, analytical performance studies would typically compare device results to a recognized reference method or instrument to establish ground truth for each analyte.

8. Sample Size for the Training Set

The provided 510(k) summary does not include information about a training set or its sample size. The device is a reflectance photometer that reads pre-impregnated test strips, not a machine learning or AI-based system that typically requires a "training set" in the conventional sense. The device is calibrated and designed based on established chemical reactions and optical principles.

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

As there is no mention of a "training set" in the context of the device's development as presented in the 510(k) summary, information on how its ground truth was established is not applicable and not provided.

Summary

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OCT 2 7 1998

<983510

510(k) Summary

Introduction	According to the requirements established in the Food and DrugAdministration's guidance document entitled "The New 510(k) Paradigm:Alternate Approaches to Demonstrating Substantial Equivalence in PremarketNotifications", the following information provides sufficient detail tounderstand the basis for a determination of substantial equivalence.
1) Submittername, address,contact	Boehringer Mannheim Corporation“doing business as Roche Diagnostics”9115 Hague Rd.Indianapolis, IN 46250(800) 428-5074 ext. 3742Contact Person: Jennifer TribbettDate Prepared: October 5, 1998
2) Device name	Proprietary name: Chemstrip 101 Urine AnalyzerCommon name: Automated Urinalysis SystemClassification name: System, Automated Urinalysis, 75KQODevice Class I
3) Predicatedevice	We claim substantial equivalence to the currently marketed RocheDiagnostics, Boehringer Mannheim Chemstrip Mini UA Urine Analyzer.

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510(k) Summary, Continued

4) DeviceDescription	The Chemstrip 101 Urine Analyzer is a reflectance photometer intended forin-vitro semi-quantitative reading of Chemstrip 10 UA urine test strips for thefollowing analytes: specific gravity, pH, leukocytes, nitrite, protein, glucose,ketones, urobilinogen, bilirubin and blood.
5) Intended use	In-vitro semi-quantitative determination of urine analytes. This is the sameintended use as previously cleared for the Chemstrip Mini Urine Analyzer(K943592).
6) Comparison	The table below indicates the similarities between the Chemstrip 101 Urine

Analyzer and the predicate device, the Chemstrip Mini UA Urine Analyzer. to predicate device:

Topic	Chemstrip 101 Urine Analyzer	Predicate: Chemstrip MiniUA Urine Analyzer
Intended Use	In-vitro semi-quantitativedetermination of urine analytes	Same
Scientific Technology	Reflectance Photometer	Same
Urine Test Strips	For use with Chemstrip 10 UA teststrips	Same
Test Parameters	Specific gravity, pH, leukocytes,nitrite, protein, glucose, ketones,urobilinogen, bilirubin and blood.	Same

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CONFIDENTIAL

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510(k) Summary, Continued

6. Comparisonto PredicateDevice	The Chemstrip 101 Urine Analyzer is a reflectance photometer intended forin-vitro semi-quantitative reading of Chemstrip 10 UA urine test strips for thefollowing analytes: specific gravity, pH, leukocytes, nitrite, protein, glucose,ketones, urobilinogen, bilirubin, and blood.
	The modifications which have been incorporated into the Chemstrip 101Urine Analyzer are:
	1.) an additional calibration fail-safe mechanism;2.) an automated test strip holder;3.) a rotating reader head, and4.) increased results memory capacity
	Calibration Fail-Safe:
	The Chemstrip 101 contains a fail-safe mechanism which prevents a test frombeing performed after the weekly instrument calibration limit. The devicesoftware will prompt the user, via a message display, to "REPEATCALIBRATION" every 7 days after the last valid calibration. This fail-safewill not allow the user to run a test strip until calibration is performed.
	In the initial (unmodified) analyzer, the "Repeat Calibration" message wasalso displayed after the 7 day calibration limit, but a lock-out mechanism wasnot incorporated which prevented the user from performing an actual test.
	This modification is an enhanced fail-safe feature.
	Automated Test Strip Tray:
	The Chemstrip 101 has eliminated the manual test strip tray by incorporatinga motor driven (automated) test strip tray. The user will place the strip on themotorized test tray and the device will automatically move the tray into theinstrument for measurement. This modification allows for the automaticpositioning of the test strip versus the manual positioning required by theinitial (unmodified) analyzer.
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510(k) Summary, Continued

F. Device description and Reader Head: comparison

Due to the test strip holder being manual and not automated, the original analyzer had 11 reader channels with fixed positioned Light Emitting Diodes (LEDs). The Chemstrip 101 utilizes the same light source (Light Emitting Diodes) and technology (reflectance photometry) as the original analyzer, but the modified device incorporates one reader head since the strip holder is capable of moving the test strip into position under the LEDs for analyte measurement.

Results Memory Capacity:

The initial (unmodified) analyzer did not have memory capability. The Chemstrip 101 incorporates the ability to store up to 100 sample results with the option of reprinting the results from memory.

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

OCT 2 7 1998

Jennifer Tribbett Regulatory Affairs Consultant Boehringer Mannheim 9115 Haque Road P.O. Box 50457 Indianapolis, Indiana 46250-0457

Re: K983510 Chemstrip 101 Urine Analyzer Requlatory Class: II Product Code: KQO, CDM, CEN, JIL, JIN, JIO, JIR, JJB, JMT, JRE, LJX Dated: October 5, 1998 October 7, 1998 Received:

Dear Ms. Tribbet:

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 aqainst 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 Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Druq Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. 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 regulations.

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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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510(k) Number (if known): Device Name: Roche Diagnostics, Boehringer Mannheim Chemstrip 101 Urine Analyzer

Indications for Use:

(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)

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K983510

Regulation Number and Section

§ 862.2900 Automated urinalysis system.

(a)
Identification. An automated urinalysis system is a device intended to measure certain of the physical properties and chemical constituents of urine by procedures that duplicate manual urinalysis systems. This device is used in conjunction with certain materials to measure a variety of urinary analytes.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.