The GL Cartridge is intended for professional use with the IRMA® Blood Analysis System for the direct measurement of sodium, potassium, glucose, and chloride in human whole blood. The GL Cartridge and the IRMA® Blood Analysis System are for in vitro diagnostic use.

The electrolyte measurements (Nat, K*, Cl ) are used to assess hydrational status, aid in the diagnosis of respiratory and metabolic acid-balance, and prevention of cardiac arrhythmia. Common disease states, which use these measurements for diagnosis, are acid-base disturbances, dehydration, diarrhea, ketoacidosis, alcoholism and other toxicities.

The measurement of glucose aids in the diagnosis and treatment of diabetes mellitus, neonatal hypoglycemia and idiopathic hypoglycemia.

Device Description

The IRMA® SL Blood Analysis System GL Cartridge is for use with the IRMA Blood Analysis System. The GL cartidge is a single use, disposable carridge, for the in vitro measurement of any of the may on the may GL cartidge comprises the analytes sodium, potassium (K945240), chloride (K981270) and glucose. Oiz currently markets cartridges with sodium, potassium, (K945240) and chloride.

Samples are introduced via syringe or capillary injections with the IRMA® Capillary Collection Device. The glucose sensor uses an amperometric electrode along with a reference electrode that measures the glucose oxidase reaction. The IRMA® sensors are calibrated prior to each test using a calibrant packaged with the sensors. Calibration of the cartridge is completed when information a canorally partil the factory for each lot of cartridges 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 abliotinal continuent a conditions, then the sample results (measured and calculated) 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 text describes the acceptance criteria and performance of the IRMA® SL Blood Analysis System GL Cartridge, specifically focusing on its glucose measurement capabilities.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" for accuracy, precision, or linearity with numerical targets. Instead, it presents the performance data of the IRMA® device and claims substantial equivalence to the predicate device, the YSI Model 2300 Stat Plus. The implied acceptance is that the performance is comparable or within an acceptable range for clinical use, particularly when compared to a legally marketed predicate device.

Based on the "Summary of Performance Data" section:

Characteristic	Acceptance Criteria (Implied by Predicate Equivalence)	Reported Device Performance (IRMA® GL Cartridge)
Accuracy (Glucose)	N/A (Substantial Equivalence to YSI 2300 Stat Plus)	Slope: 0.97Intercept: 5.47r: 0.992Sy.x: 11.08
Precision (Glucose)	N/A (Substantial Equivalence to YSI 2300 Stat Plus)	Level 1 (47.7 mg/dL): 5.9 %CVLevel 2 (103.0 mg/dL): 4.5 %CVLevel 3 (198.5 mg/dL): 4.0 %CVLevel 4 (351.3 mg/dL): 4.8 %CV
Linearity (Glucose)	N/A (Substantial Equivalence to YSI 2300 Stat Plus)	Linear over 20-500 mg/dL

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

Accuracy (Glucose):
- Sample Size: n = 37
- Data Provenance: Not explicitly stated (e.g., country of origin, prospective/retrospective). However, it's generally understood that such studies for medical devices are conducted on human samples, likely from clinical settings, and are typically prospective for regulatory submissions.
Precision (Glucose):
- Level 1: n = 59
- Level 2: n = 58
- Level 3: n = 60
- Level 4: n = 59
- Data Provenance: Not explicitly stated (e.g., country of origin, prospective/retrospective). These types of studies often use control materials or pooled patient samples to evaluate reproducibility.
Linearity (Glucose):
- Sample Size: n = 20
- Data Provenance: Not explicitly stated. Linearity studies typically involve prepared samples with known, varying concentrations.

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

This type of information (number of experts, qualifications) is not relevant for in vitro diagnostic devices like the IRMA® SL Blood Analysis System GL Cartridge. The "ground truth" for glucose measurement is established by reference methods or a predicate device, which are assumed to be accurate based on established analytical principles and prior validation. The study compares the IRMA® device's measurements to another measurement device (likely the predicate or a laboratory reference method), not to expert interpretation.

4. Adjudication Method for the Test Set

Not applicable. As explained above, this is for an in vitro diagnostic device measuring an analyte, not for subjective interpretation by experts. Ground truth is established by quantitative measurement, not expert consensus.

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

Not applicable. This device is an automated blood analysis system, not an AI-assisted diagnostic tool that involves human readers interpreting images or data. Therefore, an MRMC study and AI assistance effect size are not relevant.

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

Yes, the performance data presented (accuracy, precision, linearity) reflects the standalone performance of the IRMA® SL Blood Analysis System GL Cartridge for glucose measurement. It is an automated system designed for direct measurement.

7. The Type of Ground Truth Used

The ground truth for the glucose measurements in the performance study would have been established by a reference method or a legally marketed predicate device (YSI Model 2300 Stat Plus, mentioned as the predicate in the substantial equivalence claim). This means the measurements from the IRMA® device were compared against measurements from a highly accurate and validated method or device.

8. The Sample Size for the Training Set

The document does not specify a separate "training set" for the glucose measurement. In the context of this type of in vitro diagnostic device, the "training" for the device's internal algorithms and calibration parameters happens internally at the factory and during the initial calibration process described (using factory-derived parameters combined with measurements during daily calibration). There isn't typically a large external "training set" of patient data in the same way an AI/ML algorithm might have for image classification.

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

Given the explanation in point 8, the concept of "ground truth for the training set" as it applies to AI/ML is not directly applicable here. However, the accuracy of the device's measurements (and thus its "training" or calibration parameters) relies on the use of calibrants and control materials with known, highly accurate concentrations, which themselves are verified against reference methods. The device states: "The IRMA® sensors are calibrated prior to each test using a calibrant packaged with the sensors. Calibration of the cartridge is completed when information a canorally partil the factory for each lot of cartridges is combined with measurements taken during the calibration process. Factory derived calibration parameters are input into the analyzer by calibration code entry." This suggests the "ground truth" for its internal calibration is established through a combination of factory-set parameters and on-board calibration using precise, standardized solutions.

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 letter "D" on the left and the words "DIAMETRICS MEDICAL" on the right. The letter "D" is black and white and has a small circle at the top and three vertical lines at the bottom. The words "DIAMETRICS MEDICAL" are in black, bold, sans-serif font.

NOV 1 5 2001

Fax: 651/639.8549 Phone: 651/639.8035 55113-1136 USA 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.

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

IRMA® SL Blood Analysis System GL Cartridge

Establishment Registration Number:

Summary Prepared on:

May 21, 2001

GL Cartridge

Glucose

Class II

CGA

Glucose Test System

YSI Model 2300 Stat Plus.

21 CFR 862.1345

Chemistry (75)

2183953

Identification of Device: Device Name: Proprietary Name: Common Name:

Classification Name: Device Classification: Regulation Number: Panel: Product Code:
Name of Predicate Device:

Predicate Device 510(k) Number:

K891480

Predicate Device Product Code:

75 CGA

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 YSI Model 2300 Stat Plus.

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Device Description

Device Descripuon
The IRMA® SL Blood Analysis System GL Cartridge is for use with the IRMA Blood Analysis System. The GL cartidge is a single use, disposable carridge, for the in vitro measurement of any of the may on the may GL cartidge comprises the analytes sodium, potassium (K945240), chloride (K981270) and glucose. Oiz currently markets cartridges with sodium, potassium, (K945240) and chloride.

Intended Use

The GL Cartridge is intended for professional use with the IRMA® Blood Analysis System for the direct The OD Currities is intended to pression, and chloride in human whole blood. The GL Cartridge and the IRMA® Blood Analysis System are for in vitro diagnostic use.

Indications for Use

The electrolyte measurements (Nat, K*, Cl ) are used to assess hydrational status, aid in the diagnosis of The oreatory and metabolic acid-balance, and prevention of cardiac arrhythmia. Common disease states, which use these measurements for diagnosis, are acid-base disturbances, dehydration, diarrhea, ketoacidosis, alcoholism and other toxicities.

The measurement of glucose aids in the diagnosis and treatment of diabetes mellitus, neonatal hypoglycemia and idiopathic hypoglycemia.

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

	IRMA®	YSI Model 2300 Stat Plus
Detection Method	Glucose Oxidase	Glucose Oxidase
Analytes measured	Na+, K+,Cl-, and glucose	Glucose, Lactate
Measuring Range	Glucose: 20 - 500 mg/dL	Glucose: 0-500 mg/dL inNormal mode
		0-900 mg/dL inScreening Mode
Operating Temp.	15-30°C (59-86°F)	15.0-35°C (59-95°F)
Operating Humidity	0-80%	10-90%*
		*Non-condensing
Sample	Whole blood	Glucose: Whole Blood, serum, orplasma
	0.2 - 3.0 mL, from syringe0.125 mL from capillarycollection device	25 µL aspirated volume


Power	7.2 V NiCAD rechargeablebattery or AC adapter	120 VAC240 VAC
Reagents	Supplied in self-containeddisposable cartridge	Supplied in a Buffer Concentrate(YSI 2357) that is added to waterand a liquid Calibrator solution(YSI 2747)
Weight	5 lbs.	25 lbs.
Results	Display and printer onboard	Display and printer on board
Calibration	Automatic with eachsample	Self calibrates every 5 samples or15 minutes, or after a calibrationshift of 2% or greater, or after asample chamber temperature driftof more than 1° C.
Sensors	Disposable single-use	Reusable sensor probes

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Summary of Performance Data:

Accuracy:

Analyte	n	Range evaluated	Slope	Intercept	r	Sy.x
Glucose	37	19 - 338 mg/dl	0.97	5.47	0.992	11.08

Precision

Level	N	IRMA Glucose Mean (mg/dl)	IRMA Glucose Total Precision sd	IRMA Glucose Total Precision %CV
1	59	47.7	2.9	5.9
2	58	103.0	4.6	4.5
3	60	198.5	7.8	4.0
4	59	351.3	16.8	4.8

Linearity:

Analyte	n	Measured Range	Assessment
Glucose	20	20-500 mg/dl	Linear

Conclusions:

Conclusions:
The data demonstrates that the GL 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 shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a representation of the human form.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

NOV 1 6 2001

Ms. Nancy Ring Regulatory Affairs and Clinical Support Specialist Diametrics Medical, Inc. 2658 Patton Road Roseville, MN 55113

Re: K011586

Trade/Device Name: IRMA® SL Blood Analysis System GL Cartridge Regulation Number: 21 CFR 862.1345, 862.1170, 862.1600, 862.1665 Regulation Name: Glucose Test System, Chloride Test System, Potassium Test System, Sodium Test System

Regulatory Class: II Product Code: CGA, CGZ, CEM, JGS Dated: August 23, 2001 Received: August 24, 2001

Dear Ms. Ring:

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 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 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 (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. allouing your as a suivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory 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 regulations.

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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 nouthoution. The I Drivin 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 1 II you desire spoolite an 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, (201) 59 + 10 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 monthanon on your respond 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 Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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NOV 1 6 2001

Statement of Indications For Use

Intended Use

intended Ose
The glucose sensor is intended for professional use with the IRMA® Blood Analysis System for the direct The guccose school is michood to precessional so was as a man as a may Blood Analysis System are for in vitro diagnostic use.

Indications for Use

The measurement of glucose aids in the diagnosis and treatment of diabetes mellitus, neonatal hypoglycemia and idiopathic hypoglycemia.

Alan Coopp

ision of Clinical Laboratory Devices 510(k) Number.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use _

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(Per 21 CFR 801.109)

(Optional Format 1-2-96)

Regulation Number and Section

§ 878.4800 Manual surgical instrument for general use.

(a)
Identification. A manual surgical instrument for general use is a nonpowered, hand-held, or hand manipulated device, either reusable or disposable, intended to be used in various general surgical procedures. The device includes the applicator, clip applier, biopsy brush, manual dermabrasion brush, scrub brush, cannula, ligature carrier, chisel, clamp, contractor, curette, cutter, dissector, elevator, skin graft expander, file, forceps, gouge, instrument guide, needle guide, hammer, hemostat, amputation hook, ligature passing and knot-tying instrument, knife, mallet, disposable or reusable aspiration and injection needle, disposable or reusable suturing needle, osteotome, pliers, rasp, retainer, retractor, saw, scalpel blade, scalpel handle, one-piece scalpel, snare, spatula, stapler, disposable or reusable stripper, stylet, suturing apparatus for the stomach and intestine, measuring tape, and calipers. A surgical instrument that has specialized uses in a specific medical specialty is classified in separate regulations in parts 868 through 892 of this chapter.(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 the limitations in § 878.9.