(61 days)
Not Found
No
The description focuses on electrochemical sensing and standard signal analysis, with no mention of AI/ML terms or concepts.
No
The device is an in vitro diagnostic (IVD) device used for measuring lactate levels in human whole blood, aiding in the diagnosis and treatment of lactic acidosis, rather than directly treating a condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "for in vitro diagnostic use" and "Lactate evaluates the acid-base status and is used in the diagnosis and treatment of lactic acidosis". This indicates its purpose is to provide information for diagnosing and treating a medical condition.
No
The device description clearly outlines hardware components including a lactate sensor (amperometric electrode and reference electrode), a disposable cartridge, and the IRMA Blood Analysis System hardware. While software is involved in analyzing signals and displaying results, it is integral to a physical system.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section clearly states: "The Lactate Cartridge and the IRMA "Blood Analysis System are for in vitro diagnostic use."
- Measurement of Biomarker: The device measures lactate in human whole blood, which is a biological sample taken from the body.
- Diagnostic Purpose: The intended use states that the measurement of lactate "evaluates the acid-base status and is used in the diagnosis and treatment of lactic acidosis." This directly links the measurement to a diagnostic purpose.
- In Vitro Measurement: The "Device Description" explicitly mentions "for the in vitro measurement of lactate in whole blood," indicating the analysis is performed outside of the living organism.
N/A
Intended Use / Indications for 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.
Lactate evaluates the acid-base status and is used in the diagnosis and treatment of lactic acidosis (abnormally high acidity of the blood).
Product codes
KHP
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
professional and point of care use
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
Accuracy:
Analyte: Lactate, n: 30, Range evaluated: 1 - 250 mg/dl, Slope: 0.97, Intercept: 1.87, r: 0.991, Sy.x: 9.11
Precision:
Level 1: n: 59, IRMA Lactate Mean (mg/dl): 7.02, IRMA Lactate Total Precision sd: 1.08, IRMA Lactate Total Precision %CV: 15.3
Level 2: n: 59, IRMA Lactate Mean (mg/dl): 80.11, IRMA Lactate Total Precision sd: 4.10, IRMA Lactate Total Precision %CV: 5.1
Level 3: n: 59, IRMA Lactate Mean (mg/dl): 132.8, IRMA Lactate Total Precision sd: 8.68, IRMA Lactate Total Precision %CV: 6.5
Level 4: n: 58, IRMA Lactate Mean (mg/dl): 177.5, IRMA Lactate Total Precision sd: 16.0, IRMA Lactate Total Precision %CV: 9.0
Key Metrics
Accuracy: r: 0.991
Precision: %CV: 15.3, 5.1, 6.5, 9.0
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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: 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:
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 | |
| (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 syringe | ||
| 0.125 mL from capillary | ||
| collection device | 25 µL aspirated volume | |
| Power | 7.2 V NiCAD rechargeable | |
| battery or AC adapter | 120 VAC | |
| 240 VAC | ||
| Reagents | Supplied in self-contained | |
| disposable cartridge | Supplied in a Buffer Concentrate | |
| (YSI 2357) that is added to water | ||
| and a liquid Calibrator solution | ||
| (YSI 2747) | ||
| Weight | 5 lbs. | 25 lbs. |
| Results | Display and printer on | |
| board | Display and printer on board | |
| Calibration | Automatic with each | |
| sample | Self calibrates every 5 samples or | |
| 15 minutes, or after a calibration | ||
| shift of 2% or greater, or after a | ||
| sample chamber temperature drift | ||
| 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 |
|---|---|---|---|---|---|---|
| Lactate | 30 | 1 - 250 mg/dl | 0.97 | 1.87 | 0.991 | 9.11 |
Precision
| Level | N | IRMA
Lactate Mean
(mg/dl) | IRMA Lactate
Total Precision
sd | IRMA Lactate
Total 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.
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.
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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
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)