IRMA SL BLOOD ANALYSIS SYSTEM LACTATE CARTRIDGE

K013938 · Diametrics Medical, Inc. · KHP · Jan 28, 2002 · Clinical Chemistry

Device Facts

• Record ID: K013938
• Device Name: IRMA SL BLOOD ANALYSIS SYSTEM LACTATE CARTRIDGE
• Applicant: Diametrics Medical, Inc.
• Product Code: KHP · Clinical Chemistry
• Decision Date: Jan 28, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1450
• Device Class: Class 1

Intended Use

The lactate sensor is intended for professional and point of care use with the IRMA Blood Analysis System for the direct measurement of lactate, in human whole blood. The Lactate Cartridge and the IRMA Blood Analysis System are for in vitro diagnostic use.

Device Story

The IRMA SL Blood Analysis System Lactate Cartridge is a single-use, disposable cartridge for in vitro measurement of lactate in whole blood. Used in professional and point-of-care settings, the device accepts whole blood samples via syringe or capillary injection. It utilizes an amperometric electrode and a reference electrode to measure the lactate oxidase reaction. Before each test, the system performs an automatic calibration using factory-derived parameters and on-board calibrants. The analyzer monitors sensor signals during analysis; if abnormal conditions are detected, the test terminates and an error message is generated. Otherwise, results are displayed and can be printed. The device assists clinicians in diagnosing and treating lactic acidosis by providing rapid lactate measurements.

Clinical Evidence

Bench testing only. Accuracy evaluated against a reference method (n=30, range 1-250 mg/dL, slope 0.97, r=0.991). Precision testing conducted across four levels (n=58-59 per level) showed total precision CV ranging from 5.1% to 15.3%.

Technological Characteristics

Disposable, single-use cartridge; amperometric lactate oxidase sensor; 7.2V NiCAD rechargeable battery or AC adapter; dimensions/weight: 5 lbs; connectivity: on-board display and printer; calibration: automatic with each sample; software: rule-based error detection.

Indications for Use

Indicated for the evaluation of acid-base status and the diagnosis and treatment of lactic acidosis (abnormally high acidity of the blood) in human patients.

Regulatory Classification

Identification

A lactic acid test system is a device intended to measure lactic acid in whole blood and plasma. Lactic acid measurements that evaluate the acid-base status are used in the diagnosis and treatment of lactic acidosis (abnormally high acidity of the blood).

Predicate Devices

• YSI Model 2300 Stat Plus (K891480)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image is a logo for Diametrics Medical. The logo consists of a black square with a white "D" shape inside, with three circles above three vertical lines. To the right of the square is the text "DIAMETRICS MEDICAL" in bold, black letters.

JAN 2 8 2002

Phone: [phone] Fax: [phone] Saint Paul MN 55113-1136 USA 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: 16013938

Submitter:

Diametrics Medical, Inc. 2658 Patton Rd Roseville, MN 55113 Phone: [phone] Fax: [phone] Contact Person: Nancy Ring

Establishment Registration Number:

Summary Prepared on:

November 27, 2001

2183953

Identification of Device:

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

Lactate Cartridge IRMA® SL Blood Analysis System Lactate Cartridge Lactic Acid Test System Acid, Lactic, Enzymatic Method Class I 21 CFR 862.1450 Chemistry (75) KHP

Name of Predicate Device:

YSI Model 2300 Stat Plus.

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.

{1}------------------------------------------------

#### Device Description

The IRMA" SL Blood Analysis System Lacrate Cartridge is for use with the IRMA "Blood Analysis System. The Lactate cartridge is a single use, disposable cartridge, for the in vitro measurement of lactate in whole blood.

Samples are introduced via syringe or capillary injections with the IRMA® Capillary Collection Device. The lactate sensor uses an amperometric electrode along with a reference electrode that measures the lactate oxidase reaction. The IRMA® sensors are calibrated prior to each test using a calibrant packaged with the sensors. Calibration of the cartidge is completed when information determined at 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 there are no abnormal 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 lactate sensor is intended for professional and point of care use with the IRMA " Blood Analysis System for the direct measurement of lactate, in human whole blood. The Lactate Cartridge and the IRMA "Blood Analysis System are for in vitro diagnostic use.

#### Indications for Use

Loctate evaluates the acid-base status and is used in the diagnosis and treatment of lactic acidosis (abnormally high acidity of the blood).

{2}------------------------------------------------

# Summary of Technological Characteristics

The following table shows comparison to the predicate device.

| | IRMA® | YSI Model 2300 Stat Plus |
|--------------------|----------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Detection Method | Lactate Oxidase | Lactate Oxidase |
| Analytes measured | Lactate | Glucose, Lactate |
| Measuring Range | Lactate: 2.7 - 180.2 mg/dL<br>(0.30 - 20.00 mmol/L) | Lactate: 0-135 mg/dL<br>(0-15 mmol/L) |
| Operating Temp. | 12-30°C (59-86°F) | 15.0-35°C (59-95°F) |
| Operating Humidity | 0-80% | 10-90%*<br>*Non-condensing |
| Sample | Whole blood | Lactate: Whole Blood, serum, or 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 |

{3}------------------------------------------------

# Summary of Performance Data:

## Accuracy:

| Analyte | n | Range evaluated | Slope | Intercept | r | Sy.x |
|---------|----|-----------------|-------|-----------|-------|------|
| Lactate | 30 | 1 - 250 mg/dl | 0.97 | 1.87 | 0.991 | 9.11 |

## Precision

| Level | N | IRMA<br>Lactate Mean<br>(mg/dl) | IRMA Lactate<br>Total Precision<br>sd | IRMA Lactate<br>Total Precision<br>%CV |
|-------|----|---------------------------------|---------------------------------------|----------------------------------------|
| 1 | 59 | 7.02 | 1.08 | 15.3 |
| 2 | 59 | 80.11 | 4.10 | 5.1 |
| 3 | 59 | 132.8 | 8.68 | 6.5 |
| 4 | 58 | 177.5 | 16.0 | 9.0 |

## Linearity:

| .<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | <br>Manager of the Print of the Property of the Property of | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>A<br>1<br>LEA I REVER OR AND AND AND AND AND<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>1 6 1 60 100 000 0000 0000 0000 0<br>.<br>and the country of the driver and the driver of the children which and<br>May 19 - 100<br>AND MALL<br> | DOGES & ARLAND<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>********<br>man and consideration of the diff | | |
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|
| AAA SATTLES<br>--------<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>.<br>Status of the consisted to the first of the first | . | --------------<br>A come a coment<br>-------------------------------------<br><br><br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>and should be also all a do a<br><br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>.<br>-----------------------------------------------------------------------------------<br>----------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>.<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------<br>----------<br>A CON LIES LEASE<br>CARSONAL COLUMN AND COLLEGION AND | | |

# Conclusions:

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

{4}------------------------------------------------

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, which is a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus. The logo is black and white.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JAN 2 8 2002

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

Re: k013938

Trade/Device Name: Diametrics Medical, Inc, IRMA® Blood Analysis System Lactate Cartridge

Regulation Number: 21 CFR 862.1450 Regulation Name: Lactic Acid test system Regulatory Class: Class I Product Code: KHP Dated: November 27, 2001 Received: November 28, 2001

Dear Ms. Ring:

We have reviewed your Section 510(k) premarket notification of intent to market the device w f nate roview a your co determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for about in the encreases)76, 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 or any I 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.

{5}------------------------------------------------

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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact 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 Manufacturers International 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 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

{6}------------------------------------------------

# Statement of Indications For Use

## Intended Use

The lactate sensor is intended for professional and point of care use with the IRMA " Blood Analysis System for the direct measurement of lactate, in human whole blood. The Lactate Cartridge and the IRMA "Blood Analysis System are for in vitro diagnostic use.

### Indications for Use

Lactate evaluates the acid-base status and is used in the diagnosis and treatment of lactic acidosis (abnormally high acidity of the blood).

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

| A |
|---|
|---|

| (Division Sign-Off) | |
|-----------------------------------------|---------|
| Division of Clinical Laboratory Devices | |
| 510(k) Number | K017138 |

------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use_V

OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(Per 21 CFR 801.109)

(Optional Format 1-2-96)