(45 days)
Not Found
No
The summary describes a laboratory control material for monitoring precision and does not mention any computational or analytical features that would suggest the use of AI or ML.
No
The device is a quality control material for laboratory testing procedures, not a device used for treating or diagnosing medical conditions.
No
This device is a control material used for monitoring the precision of laboratory testing procedures, not for diagnosing medical conditions in patients.
No
The device description clearly states it is a suspension of stabilized human red blood cell components and other constituents, provided in liquid form. This indicates a physical, non-software component.
Based on the provided information, yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that Meter Trax is an "assayed whole blood control used in monitoring the precision of laboratory testing procedures for the analytes listed in this package insert." This clearly indicates it's used in vitro (outside the body) to evaluate the performance of diagnostic tests.
- Device Description: The description details the composition of the control material, which is a suspension of biological components and chemicals. This is consistent with the nature of IVD control materials.
- Analytes: The listed analytes (Glucose, Hemoglobin, Hematocrit) are common parameters measured in clinical laboratory testing.
- Intended User / Care Setting: The intended user is a "laboratory," which is the typical setting for IVD testing.
- Performance Studies: The mention of stability studies, while not providing full performance metrics, is a common requirement for IVD devices to demonstrate their reliability over time.
- Predicate Device: The mention of a predicate device with a K number (K904461) strongly suggests that this device is being compared to a previously cleared IVD device.
The core function of Meter Trax is to serve as a quality control material for in vitro diagnostic tests. This directly aligns with the definition and purpose of an IVD.
N/A
Intended Use / Indications for Use
Meter Trax is an assayed whole blood control used in monitoring the precision of laboratory procedures for glucose, hemoglobin and hematocrit testing.
Product codes
JPK, JJY
Device Description
Meter Trax Control is a suspension of stabilized human red blood cell components with added constituents of animal origin, chemicals, stabilizers, and preservatives. This product is provided in liquid form for convenience.
Mentions image processing
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Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Stability studies have been performed to determine the open vial stability and shelf life for the Meter Trax Control. Product claims are as follows:
- 1.1 Open vial Stability:
Claims: Hernatocrit will be stable for 31 days at 2 to 8°C. Glucose and Hemoglobin will be stable for 31 days at 2 to 8°C or 18 to 30°C. 1 - 1.2 Shelf Life Stability
Claims: 180 days at 2 to 8℃
All supporting data is retained on file at Bio-Rad Laboratories.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 864.8625 Hematology quality control mixture.
(a)
Identification. A hematology quality control mixture is a device used to ascertain the accuracy and precision of manual, semiautomated, and automated determinations of cell parameters such as white cell count (WBC), red cell count (RBC), platelet count (PLT), hemoglobin, hematocrit (HCT), mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), and mean corpuscular hemoglobin concentration (MCHC).(b)
Classification. Class II (special controls). Except when intended for use in blood components, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.
0
Summary of Safety and Effectiveness : Meter Trax Control
1.0 Submitter
Bio-Rad Laboratories " 9500 Jeronimo Road, Irvine, California 92618-2017 Telephone: (949) 598-1200 Fax: (949) 598-1557
Contact Person
Maria Zeballos Regulatory Affairs Specialist Telephone: (949) 598-1367
Date of Summary Proparation
August 25, 2004
2.0 Device Identification
| Product Trade Name: | Meter Trax Control |
|---|---|
| Common Name: | Hematology and Pathology Devices |
| (Hematology quality control mixture) | |
| Classifications: | Class II |
| Product Code: | JPK |
| Regulation Number: | 21 CFR 864.8625 |
Device to Which Substantial Equivalence is Claimed 3.0
Meter Trax is an assayed whole blood control used in monitoring the precision of faboratory procedures for glucose, hemoglobin and hematocrit testing. This control is substantially equivalent to the following quality control materials that are currently in the market:
Meter Trax Bio-Rad Laboratories (formerly Hematronix, Inc.) Plano, Texas 75074 | 510 (k) Number: K904461
4.0 Description of Device
Meter Trax Control is a suspension of stabilized human red blood cell components with added constituents of animal origin, chemicals, stabilizers, and preservatives. This product is provided in liquid form for convenience.
Intended Use
Meter Trax is an assayed whole blood control used in monitoring the precision of laboratory procedures for glucose, hemoglobin and hematocrit testing.
1
Comparlson of the new device with the Predicate Device 5.0
Meter Trax Control is substantial equivalent to Meter Trax (K904461) currently in commercial distribution The similarities and differences are listed below.
| Characteristics | Bio-Rad
Meter Trax Control
(New Device) | Bio-Rad Laboratories
(formerly Hematronix, Inc.)
Meter Trax
(Predicate Device K904481) |
|-----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------|
| Matrix | Human Whole Blood based | Human Whole Blood based |
| Stabilizers | Contains stabilizers | Does not contain stabilizers |
| Form | Liquid | Liquid |
| Storage
(Unopened) | 2°C to 8°C
Until expiration date | 2°C to 8°C
Until expiration date |
| Open vial Stability | Hematocrit: 31days at 2 to 8°C
Glucose and Hemoglobin: 31days at 2 to 8°C
or 18 to 30°C | Hematocrit: 31 days at 2 to 8°C
Glucose and Hemoglobin: 31days at 2 to 8°C
or 18 to 30°C |
| Analytes | Contains the following parameters:
Glucose
Hemoglobin
Hematocrit | Contains the following parameters:
Glucose
Hemoglobin
Hematocrit |
| Intended Use | Meter Trax is an assayed whole blood control used in
monitoring the precision of laboratory procedures for
glucose, hemoglobin and hematocrit testing. | Meter Trax™ Control is intended for use as a whole
blood reference control for glucose, hemoglobin, and
hematocot |
Table 1. Similarities and Differences between new and predicate device.
1.0 STATEMENT OF SUPPORTING DATA
Stability studies have been performed to determine the open vial stability and shelf life for the Meter Trax Control. Product claims are as follows:
- 1.1 Open vial Stability:
Claims: Hernatocrit will be stable for 31 days at 2 to 8°C. Glucose and Hemoglobin will be stable for 31 days at 2 to 8°C or 18 to 30°C. 1
1.2 Shelf Life Stability
Claims: 180 days at 2 to 8℃
All supporting data is retained on file at Bio-Rad Laboratories.
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services. The logo features a stylized eagle with three lines representing its wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.
OCT 1 4 2004
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Maria Zeballos Regulatory Affairs Specialist Bio-Rad Laboratories 9500 Jeronimo Road Irvine, CA 92618-2017
K042336 Trade/Device Name: Meter Trax Control Regulation Number: 21 CFR 864.8625 Regulation Name: Hematology Quality Control Mixture Regulatory Class: Class II Product Code: JPK, JJY Dated: August 25, 2004 Received: August 30, 2004
Dear Ms. Zeballos:
Re:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) 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 Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 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.
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If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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,
Robert L. Becker Jr.
Robert L. Becker, Jr., M.D., Ph. Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known):
Device Name:
Meter Trax Control
Indications For Use:
Meter Trax is an assayed whole blood control used in monitoring the precision of laboratory testing procedures for the analytes listed in this package insert.
The following parameters are listed in the package insert:
- · Glucose
- Hemoglobin
- · Hematocrit
Prescription Use _____________________________________________________________________________________________________________________________________________________________
AND/OR
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Xitro Diagnostic Devices (OIVD)
Josephine Bautista
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510 K042336
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