IRMA SL BLOOD ANALYSIS SYSTEM GL CARTRIDGE

K011586 · Diametrics Medical, Inc. · GAA · Nov 16, 2001 · General, Plastic Surgery

Device Facts

• Record ID: K011586
• Device Name: IRMA SL BLOOD ANALYSIS SYSTEM GL CARTRIDGE
• Applicant: Diametrics Medical, Inc.
• Product Code: GAA · General, Plastic Surgery
• Decision Date: Nov 16, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4800
• Device Class: Class 1
• Attributes: Pediatric

Indications for Use

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

Device Story

The IRMA SL Blood Analysis System GL Cartridge is a single-use, disposable cartridge for in vitro diagnostic measurement of sodium, potassium, chloride, and glucose in human whole blood. Samples are introduced via syringe or capillary injection using the IRMA Capillary Collection Device. The glucose sensor utilizes an amperometric electrode and a reference electrode to measure the glucose oxidase reaction. The system performs automatic calibration prior to each test using factory-derived parameters and on-board calibrants. The analyzer processes sensor signals, performs error checking, and displays measured and calculated results, with an optional hard-copy printout. Used in clinical settings by healthcare professionals, the device provides rapid blood analysis to aid in the diagnosis and management of metabolic and electrolyte disorders, potentially improving patient outcomes through timely clinical decision-making.

Clinical Evidence

Bench testing only. Accuracy study (n=37) across 19-338 mg/dL range showed a slope of 0.97, intercept of 5.47, and r=0.992. Precision testing (n=58-60 per level) across four levels (47.7-351.3 mg/dL) demonstrated total precision %CV between 4.0% and 5.9%. Linearity was confirmed over the 20-500 mg/dL range.

Technological Characteristics

Disposable single-use cartridge; amperometric glucose oxidase sensor; 7.2V NiCAD rechargeable battery or AC adapter; dimensions/weight: 5 lbs; operating range 15-30°C, 0-80% humidity; automatic calibration with each sample; results via on-board display and printer.

Indications for Use

Indicated for professional use to measure electrolytes (Na+, K+, Cl-) to assess hydrational status, acid-base balance, and cardiac arrhythmia risk in patients with acid-base disturbances, dehydration, diarrhea, ketoacidosis, alcoholism, or other toxicities. Glucose measurement is indicated for the diagnosis and treatment of diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia.

Regulatory Classification

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.

Predicate Devices

• YSI Model 2300 Stat Plus (K891480)

Submission Summary (Full Text)

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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: [phone] Phone: [phone]-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: [phone] Fax: [phone] 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.

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.

#### 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 in<br>Normal mode |
| | | 0-900 mg/dL in<br>Screening 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, or<br>plasma |
| | 0.2 - 3.0 mL, from syringe<br>0.125 mL from capillary<br>collection device | 25 µL aspirated volume |
| | | |
| | | |
| Power | 7.2 V NiCAD rechargeable<br>battery or AC adapter | 120 VAC<br>240 VAC |
| Reagents | Supplied in self-contained<br>disposable cartridge | Supplied in a Buffer Concentrate<br>(YSI 2357) that is added to water<br>and a liquid Calibrator solution<br>(YSI 2747) |
| Weight | 5 lbs. | 25 lbs. |
| Results | Display and printer on<br>board | Display and printer on board |
| Calibration | Automatic with each<br>sample | Self calibrates every 5 samples or<br>15 minutes, or after a calibration<br>shift of 2% or greater, or after a<br>sample chamber temperature drift<br>of 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 [phone]. Additionally, for questions on the promotion and advertising of your device, (201) 59 + 10 the office of Compliance at [phone]. 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 [phone] or [phone] 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 _

OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(Per 21 CFR 801.109)

(Optional Format 1-2-96)