Intended Use: The CR cartridge is intended for professional use with the IRMA® Blood Analysis System for the direct measurement of creatinine, in human whole blood. The CR cartridge and the IRMA® Blood Analysis System are for in vitro diagnostic use.
Indications for Use: The measurement of creatinine aids in the diagnosis and treatment of certain renal diseases, and in monitoring renal dialysis.

Device Description

The IRMA® SL Blood Analysis System CR Creatinine Cartridge is for use with the IRMA Blood Analysis System. The creatinine cartridge is a single use, disposable cartridge, for the in vitro measurement of creatinine in whole blood. Samples are introduced via syringe or capillary injections with the IRMA® Capillary Collection Device. The creatinine sensor uses an enzymatic method for measuring creatinine. The IRMA sensors are calibrated prior to each test using a calibrant packaged with the sensor. Calibration of the cartridge is completed when information determined at the factory for each lot of cartidges is combined with measurements taken during the calibration process. Factory derived calibration parameters are input into the analyzer by calibration code entry. Throughout the calibration and analysis process, signals from the sensors are analyzed. If any abnormal conditions are detected, an error message is generated and the test will be terminated. If there are no abnormal conditions, then the sample results are displayed after successful calibration and analysis. In addition, the user has the option to print a hard copy of the results.

AI/ML Overview

The provided document describes the IRMA® SL Blood Analysis System CR Creatinine Cartridge, a device for in vitro measurement of creatinine in whole blood. The study presented focuses on demonstrating substantial equivalence to a predicate device, rather than defining and proving acceptance criteria in a typical AI/ML medical device submission format.

However, based on the performance data provided, we can infer some "acceptance criteria" through comparison with the reported device performance, particularly in the context of demonstrating substantial equivalence to a predicate device.

Here's an attempt to structure the information according to your request, with a strong caveat that this is an interpretation of the provided regulatory submission format.

Acceptance Criteria and Study Details for the IRMA® SL Blood Analysis System CR Creatinine Cartridge

The provided document, a 510(k) summary, demonstrates the substantial equivalence of the IRMA® SL Blood Analysis System CR Creatinine Cartridge to a predicate device (Vitros DT60 II Chemistry System / Vitros CRSC DT Slides). The acceptance criteria are implicitly derived from the performance deemed acceptable for equivalence in the context of an in vitro diagnostic device, specifically regarding accuracy, precision, and linearity.

1. Table of Acceptance Criteria and Reported Device Performance:

Since explicit acceptance criteria are not stated as pass/fail thresholds but rather performance characteristics for substantial equivalence, the "acceptance criteria" are represented by the demonstrated performance itself, showing it is comparable to or better than the predicate device and within clinically acceptable ranges.

Performance Metric	Implied Acceptance Criteria (via predicate comparison/clinical expectation)	Reported Device Performance (IRMA® CR Creatinine Cartridge)
Accuracy (vs. Predicate)	High correlation (R value close to 1), low bias (slope close to 1, intercept close to 0).	Slope: 0.94 Intercept: 0.16 R (correlation coefficient): 0.98 Sy.x (Standard Error of the Estimate): 0.55
Precision (Total Precision %CV)	Acceptable variability across clinically relevant concentrations. Lower %CV indicates better precision.	Level 1 (0.67 mg/dl): 12.6% Level 2 (1.93 mg/dl): 3.8% Level 3 (4.41 mg/dl): 9.1% Level 4 (10.17 mg/dl): 6.9% Level 5 (17.80 mg/dl): 7.7% Level 6 (22.68 mg/dl): 7.3%
Linearity	Device measurements should be linear across its claimed measuring range.	Assessment: Linear across 0.2 – 20.0 mg/dl
Measuring Range	Must cover clinically relevant creatinine concentrations.	0.2 - 20.0 mg/dL (17.7 - 1768.5 mmol/L)
Minimum Detection Limit	Sufficiently low to detect clinically relevant low creatinine levels.	0.04 mg/dl (3.5 mmol/L)

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

Accuracy Test Set (Correlation Study): The number of samples for the accuracy study is ambiguously reported as 1. However, the range evaluated was 0.5 - 10.1 mg/dl, suggesting multiple samples were indeed used to calculate the slope, intercept, and correlation coefficient. The exact number of individual patient samples in the test set is not explicitly stated in the provided text.
Precision Test Set: The number of replicates (N) for each level ranged from 12 to 60.
- Level 1: N=12
- Level 2: N=56
- Level 3: N=54
- Level 4: N=58
- Level 5: N=60
- Level 6: N=52
Data Provenance: The document does not specify the country of origin of the data or whether the study was retrospective or prospective. Given the nature of a 510(k) submission for an IVD, it's typically prospective clinical laboratory testing.

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

This device is an in vitro diagnostic (IVD) based on enzymatic methods, not an AI/ML device relying on expert image interpretation. Therefore, "experts" in the context of establishing ground truth (e.g., radiologists, pathologists) are not applicable in the same way. The ground truth (reference values) would have been established by the predicate device (Vitros DT60 II Chemistry System / Vitros CRSC DT Slides) and/or other established laboratory methods, which are inherently "expert" systems in the sense of being widely accepted and validated.

4. Adjudication Method for the Test Set:

Not applicable as this is a biochemical measurement comparison, not a diagnostic interpretation from human readers.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No, this is not an MRMC study. It is a comparison of an IVD device's performance to a predicate IVD device. The concept of "human readers improve with AI vs without AI assistance" is not relevant here.

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

The performance data presented is standalone performance, as it represents the analytical performance of the IRMA® SL Blood Analysis System CR Creatinine Cartridge itself (accuracy, precision, linearity). Although it's an IVD test and operators are involved in sample handling, the "algorithm" (enzymatic method) performance is evaluated directly.

7. The Type of Ground Truth Used:

Accuracy Study: The ground truth for the accuracy study was established by comparing the IRMA® device's results to those of the predicate device, the Vitros DT60 II Chemistry System / Vitros CRSC DT Slides.
Precision and Linearity Studies: Ground truth (reference values) would be established using known control materials or dilutions of samples with known concentrations, or by reference methods, though specific details are not provided.

8. The Sample Size for the Training Set:

Not applicable in the context of this device and study. This device uses an enzymatic chemical method, not a machine learning algorithm that requires a "training set" in the conventional sense. The "calibration" process mentioned (combining factory-determined information with measurements during calibration) serves a similar function to training in some ways, but it's not a data-driven training set like in AI/ML.

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

Not applicable as there is no "training set" in the AI/ML context. Calibration for the cartridge is described as combining "information determined at the factory for each lot of cartridges" with "measurements taken during the calibration process" using a calibrant packaged with the sensor. This factory information and calibrant effectively establish the "ground truth" for the device's internal calibration.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for Diametrics Medical. The logo consists of a stylized "D" shape on the left, followed by the words "DIAMETRICS" and "MEDICAL" stacked on top of each other. The "D" shape is black and white and has a few circles and lines inside of it.

JUN 2 5 2003

Fax: 651/639.8549 55113-1136 USA Phone: 651/639.8035 Saint Paul MN 2658 Patton Road

510(k) Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA1990 and 21 CFR 807.92.

1030035 The assigned 510(k) number is: _

Submitter:

Diametrics Medical, Inc. 2658 Patton Rd Roseville, MN 55113 Phone: (651) 638-1250 Fax: (651) 638-1060 Contact Person: Nancy Ring

Establishment Registration Number:

Summary Prepared on:

Identification of Device:

Device Name: Proprietary Name: Cartridge Common Name: Classification Name: Device Classification: Regulation Number: Panel: Product Code:

Name of Predicate Device:

Predicate Device 510(k) Number:	K875191
Predicate Device Product Code:	75 JFY

Substantial Equivalence Claim

The IRMA® SL Blood Analysis System GL Cartridge is substantially equivalent in method, intended use and clinical performance to the currently marketed Vitros DT60 H Chemistry System / Vitros CRSC DT Slides.

2183953

January 2, 2003

Creatinine Cartridge IRMA® SL Blood Analysis System CR

Creatinine Test System Enzymatic method, creatinine Class II 21 CFR 862.1225 Chemistry (75) ורצ

Vitros DT60 II Chemistry System / Vitros CRSC DT Slides

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Device Description

Samples are introduced via syringe or capillary injections with the IRMA® Capillary Collection Device. The creatinine sensor uses an enzymatic method for measuring creatinine. The IRMA sensors are calibrated prior to each test using a calibrant packaged with the sensor. Calibration of the cartridge is completed when information determined at the factory for each lot of cartidges is combined with measurements taken during the calibration process. Factory derived calibration parameters are input into the analyzer by calibration code entry.

Throughout the calibration and analysis process, signals from the sensors are analyzed. If any abnormal conditions are detected, an error message is generated and the test will be terminated. If there are no abnormal conditions, then the sample results are displayed after successful calibration and analysis. In addition, the user has the option to print a hard copy of the results.

Intended Use

The CR cartridge is intended for professional use with the IRMA® Blood Analysis System for the direct measurement of creatinine, in human whole blood. The CR cartridge and the IRMA® Blood Analysis System are for in vitro diagnostic use.

Indications for Use

The measurement of creatinine aids in the diagnosis and treatment of certain renal diseases, and in monitoring renal dialysis.

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Summary of Technological Characteristics
The following table shows comparison to the predicate device.

	IRMA®	Vitros DT60 II
Detection Method	Creatinine Oxidase	Creatinine amidohydrolase /creatinine amidinohydrolase /sarcosine oxidase
Measuring Range	Creatinine: 0.2 - 20.0mg/dL (17.7 - 1768.5mmol/L)	Creatinine: 0.05 - 16.5 mg/dL(4 - 1459 mmol/L)
Minimum DetectionLimit	Creatinine: 0.04 mg/dl(3.5 mmol/L)	Not Specified
Operating Temp.	12-30°C (59-86°F)	15.5-35°C (60-85°F)
Operating Humidity	0-80%	15-75%
Sample	Whole blood	Serum or plasma
	0.2 - 3.0 mL, from syringe0.125 mL from capillarycollection device	10 µL
Power	7.2 V NiCAD rechargeablebattery or AC adapter	120 VAC240 VAC
Reagents	Supplied in self-containeddisposable cartridge	Supplied in a dry multi-layeredfilm within a disposable plasticsupport
Weight	5 lbs.	19 lbs.
Results	Display and printer onboard	Display and printer on board
Calibration	Automatic with eachsample	Manual calibration with each newlot of Vitros DT slides, or whenQC results using Vitros DTControls are out of range

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Summary of Performance Data:

Accuracy:

curacy:
Analyte	1	Range evaluated	Slope	Intercept		Sy.xA market of the comments of the country of the county of
Company of ChildrenCreatinineThe later the many of the many of the county of the county of the county of the county of the county of the county of the county of the county of the county of the county of	10	0.5 - 10.1 mg/dl	0.94	0.16	0.98	0.55

Precision:

Level	N	IRMACreatinineMean (mg/dl)	IRMACreatinine TotalPrecision sd	IRMA CreatinineTotal Precision%CV
1	12	0.67	0.085	12.6
2	56	1.93	0.073	3.8
3	54	4.41	0.399	9.1
4	58	10.17	0.704	6.9
5	60	17.80	1.366	7.7
6	52	22.68	1.654	7.3

Linearity:

Analyte		Display Rangeand the state the station and the first and the first of the first of the first and	Assessment
CreatinineComments of the controlled on the controlled on the controlled of the controlled of the controlled of the contribution of the contribution of the contribution of the contribu	20	0.2 – 20.0 mg/dl	LinearThe first and the many of the many of the many of the many of the many of the may be any the may be any the comments of the may be the comments of the comments of the comment

Conclusions:

The data demonstrates that the Creatinine Cartridge is as safe, effective and performs as well as the legally marketed predicate device to which equivalence is claimed.

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Image /page/4/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of a human figure with outstretched arms, which is meant to represent the department's mission of protecting the health of all Americans. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the figure.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JUN 2 5 2003

Ms. Nancy Ring QA/RA Manager Diametrics Medical 2658 Patton Road Saint Paul, MN 55113-1136

Re: K030035

Trade/Device Name: IRMA® SL Blood Analysis System CR cartridge Regulation Number: 21 CFR 862.1225 Regulation Name: Creatinine test system Regulatory Class: Class II Product Code: JFY Dated: April 11, 2003 Received: April 14, 2003

Dear Ms. Ring:

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. Iisting 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); 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 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 information about the application of labeling requirements to your device. or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97), 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Steven Sutman

Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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K030035

Statement of Indications For Use

Intended Use

Indications for Use

Creatinine measurements are used in the diagnosis and treatment of certain renal disease, and in monitoring renal dialysis.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use	OR	Over-The-Counter Use
(Per 21 CFR 801.109)		(Optional Format 1-2-96)

Willis Sals' to Juan Cooper

(Division Sign-Division of Clinical Labor 510(k) Number

Regulation Number and Section

§ 862.1225 Creatinine test system.

(a)
Identification. A creatinine test system is a device intended to measure creatinine levels in plasma and urine. Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes.(b)
Classification. Class II.