(122 days)
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No
The description focuses on spectroscopic technology and built-in self-tests, with no mention of AI or ML terms or concepts.
No
The device is described as an in vitro diagnostic device for quantitative testing of blood components, not for treating or diagnosing a disease or condition in a patient.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states "HemoNIR is intended for in vitro diagnostic use."
No
The device description explicitly states it is a "small, portable, battery-powered system" that uses "spectroscopic technology" and "disposable sample tabs," indicating it is a hardware device with integrated software, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that HemoNIR is "intended for in vitro diagnostic use by healthcare professionals in quantitative testing of whole blood".
- Device Description: The description details how the device analyzes a sample of whole blood (approximately 10uL) placed on a disposable sample tab. This process of analyzing a biological sample outside of the body is the core definition of an in vitro diagnostic.
- Sample Type: The device tests "whole blood", which is a biological sample.
- Testing Location: The testing is performed on the sample in the device, not on the patient.
All of these points align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
HemoNIR is intended for in vitro diagnostic use by healthcare professionals in quantitative testing of whole blood for total hemoglobin, methernoglobin and carboxyhemoglobin.
Product codes
JKS, GLY
Device Description
HemoNIR ... "M is a small, portable, battery-powered system using rechargeable batteries to measure total hemoglobin, methemoglobin and carboxyhemoglobin using spectroscopic technology. The system uses inexpensive disposable sample tabs and requires no sample preparation or reagents. Samples are introduced into the HemoNIR, JM by using sample tabs. The sample tab well is filled with approximately 10uL of sample and is then inserted into the sample slot of the HemoNIR, "10 unit. The unit automatically starts-up and runs its built-in self-test before performing the measurements. After less than 30 seconds from sample insertion, results will be displayed on the built-in LCD.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
healthcare professionals
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
Studies were conducted to evaluate the performance characteristics of the HemoNIR, "M. A method comparison study was performed with the HemoNIR, "M and a commercially available system. Linearity, precision and interference studies were also conducted using the HemoNIR These studies demonstrated that the HemoNIRLabTM performs in accordance with its specifications.
Key Metrics
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Predicate Device(s)
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 864.7500 Whole blood hemoglobin assays.
(a)
Identification. A whole blood hemoglobin assay is a device consisting or reagents, calibrators, controls, or photometric or spectrophotometric instrumentation used to measure the hemoglobin content of whole blood for the detection of anemia. This generic device category does not include automated hemoglobin systems.(b)
Classification. Class II (special controls). An acid hematin intended for use with whole blood hemoglobin assays is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.
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K05 00/4
MAY - 5 2005
510(k) Summary for HemoNIRLab™
SPONSOR 1.
NIR Diagnostics Inc. 44 Crawford Crescent Campbellville, Ontario, L0P 1B0 Canada
Contact Person: Ashwani Kaushal, Vice President, Engineering 905-854-5727 Telephone:
Date Prepared: December 30, 2004
DEVICE NAME 2.
| Proprietary Name: | HemoNIRLabTM |
|---|---|
| Common/Usual Name: | Whole Blood Hemoglobin Assays |
| Classification Name: | Oximeter to Measure Hemoglobin |
PREDICATE DEVICES 3.
DEVICE DESCRIPTION 4.
HemoNIR ... "M is a small, portable, battery-powered system using rechargeable batteries to measure total hemoglobin, methemoglobin and carboxyhemoglobin using spectroscopic technology. The system uses inexpensive disposable sample tabs and requires no sample preparation or reagents.
1
Samples are introduced into the HemoNIR, JM by using sample tabs. The sample tab well is filled with approximately 10uL of sample and is then inserted into the sample slot of the HemoNIR, "10 unit. The unit automatically starts-up and runs its built-in self-test before performing the measurements. After less than 30 seconds from sample insertion, results will be displayed on the built-in LCD.
ડ. INTENDED ÜSE
HemoNIR, "TM is intended for in vitro diagnostic use by healthcare professionals in quantitative testing of whole blood for total hemoglobin, methemoglobin and carboxyhemoglobin.
TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE 6.
The HemoNIR , TM and the cited predicate devices are all intended for the measurement of total hemoglobin, methemoglobin quantitative and carboxyhemoglobin in samples of anticoagulated whole blood. No sample preparation or reagents are required for either the HemoNIR, M or the AVOXimeter 4000, whereas the OSM3 Hemoximeter requires ultrasonic hemolyzation and use of reagents.
Another similarity is that all three devices utilize a spectroscopic measurement method. For the HemoNIR , "M continuous wavelengths are used while the OSM3 Hemoximeter and AVOXimeter 4000 use six and five wavelengths, respectively. The HemoNIR _ TM is also more compact than the cited predicate devices.
PERFORMANCE TESTING 7.
Electrical Testing
The HemoNIR, "M underwent electrical safety testing and electromagnetic compatibility testing and was found to be in compliance with applicable requirements of IEC 61010-1, IEC 61010-2-101, FCC 47 CFR part 15, and EN 61326.
Performance Testing
Studies were conducted to evaluate the performance characteristics of the HemoNIR, "M. A method comparison study was performed with the HemoNIR, "M and a commercially available system. Linearity, precision and interference studies were also conducted using the HemoNIR These studies demonstrated that the HemoNIRLabTM performs in accordance with its specifications.
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Image /page/2/Picture/0 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an image of a stylized eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
NIR Diagnostics, Inc. c/o Ms. Cynthia A. Sinclair, RAC Senior Staff Consultant Medical Device Consultants, Inc. 49 Plain Street North Attleboro, MA 02760
MAY - 5 2005
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
K050014 Re:
Trade/Device Name: NIR Diagnostics Inc., HemoNIR120 TM Regulation Number: 21 CFR § 862.7500 Regulation Name: Oximeter to measure hemoglobin Regulatory Class: II Product Code: JKS, GLY ﭘﯿ Dated: April 14, 2005 Received: April 18, 2005
Dear Ms. Sinclair:
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 (240) 276-0484. 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/industry/support/index.html
Sincerely yours,
Robert Beckerh
Robert L. Becker, Jr., MD, PK Director Division of Immunology and Hematology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known):
Device Name: HemoNIRLaoTM
Indications for Use:
HemoNIR is intended for in vitro diagnostic use by healthcare professionals in quantitative testing of whole blood for total hemoglobin, methernoglobin and carboxyhemoglobin.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-the-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)
Joceline Bautista
Division Sign-Off
Division/Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K050014