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.

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

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.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Diametrics Medical IRMA® SL Blood Analysis System Lactate Cartridge, based on the provided text:

Acceptance Criteria and Device Performance

Criteria (Type of Performance)	Acceptance Criteria (Not explicitly stated as criteria, but implied by performance data)	Reported Device Performance (IRMA® SL Lactate Cartridge)
Accuracy	Comparable to predicate device (YSI Model 2300 Stat Plus)	Slope: 0.97, Intercept: 1.87, r: 0.991, Sy.x: 9.11
Precision	(No explicit numerical criteria given, but implied to be acceptable for clinical use)	Level 1: Mean 7.02 mg/dl, sd 1.08, %CV 15.3
		Level 2: Mean 80.11 mg/dl, sd 4.10, %CV 5.1
		Level 3: Mean 132.8 mg/dl, sd 8.68, %CV 6.5
		Level 4: Mean 177.5 mg/dl, sd 16.0, %CV 9.0
Linearity	(No explicit criteria or detailed results provided in the legible text)	(Insignificant/Illegible text provided)

Note: The document states "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." This implies that the observed performance meets an unstated acceptance criterion of being comparable to the predicate device.

Study Details

Sample sizes used for the test set and data provenance:
- Accuracy: n = 30 (Range evaluated 1 - 250 mg/dl).
- Precision: Levels 1, 2, and 3 had n = 59 each. Level 4 had n = 58.
- Data Provenance: Not specified in the provided text (e.g., country of origin, retrospective or prospective).
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided in the document. For in vitro diagnostic devices like this, ground truth is typically established by comparative methods using a reference laboratory instrument, not by expert consensus on imaging or clinical interpretation.
Adjudication method for the test set:
- This information is not applicable/provided for this type of in vitro diagnostic device study. Adjudication methods like 2+1 or 3+1 are typically used in studies involving human interpretation (e.g., radiology studies).
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:
- No, an MRMC comparative effectiveness study was not done. This is an in vitro diagnostic device (IVD) for direct measurement, not an AI-assisted diagnostic tool that would involve human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, implicitly. The performance data (accuracy, precision, linearity) presented are the standalone performance of the IRMA® SL Blood Analysis System Lactate Cartridge itself, as an automated in vitro diagnostic device without human interpretation as part of the core measurement process. Human interaction is limited to sample collection, cartridge insertion, and reading the displayed results.
The type of ground truth used:
- For accuracy, the ground truth would have been established by comparing the device's results against a reference method or a legally marketed predicate device (YSI Model 2300 Stat Plus, which is mentioned as the predicate). The "Slope," "Intercept," and "r" values indicate a regression analysis comparing the new device to a reference.
- For precision, the ground truth is statistical, derived from repeated measurements of the same sample, indicating reproducibility.
The sample size for the training set:
- Not applicable/provided. This device is a sensor-based system, not an AI/machine learning algorithm that requires a "training set" in the conventional sense. The "factory derived calibration parameters" mentioned in the device description contribute to its operational accuracy, but this is a manufacturing/calibration process, not an AI training process.
How the ground truth for the training set was established:
- Not applicable/provided for the reason stated in point 7. The calibration of the cartridge uses "information determined at the factory for each lot of cartridges" and "measurements taken during the calibration process." This involves pre-determined factory parameters and on-site calibration measurements, not a ground truth established for a "training set" in an AI context.

Summary

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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: 651/639.8035 Fax: 651/639.8549 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: (651) 638-1250 Fax: (651) 638-1060 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.

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Device Description

Intended 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).

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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	Lactate Oxidase	Lactate Oxidase
Analytes measured	Lactate	Glucose, Lactate
Measuring Range	Lactate: 2.7 - 180.2 mg/dL(0.30 - 20.00 mmol/L)	Lactate: 0-135 mg/dL(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%**Non-condensing
Sample	Whole blood	Lactate: Whole Blood, serum, or plasma
	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
Lactate	30	1 - 250 mg/dl	0.97	1.87	0.991	9.11

Precision

Level	N	IRMALactate Mean(mg/dl)	IRMA LactateTotal Precisionsd	IRMA LactateTotal Precision%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:

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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.

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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 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.

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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 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" (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 (800) 638-2041 or (301) 443-6597 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

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Statement of Indications For Use

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use_V

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(Per 21 CFR 801.109)

(Optional Format 1-2-96)

Regulation Number and Section

§ 862.1450 Lactic acid test system.

(a)
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).(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.