(55 days)
Not Found
No
The description details a photometric system measuring absorbance, a standard method for hemoglobin analysis, with no mention of AI/ML algorithms for data processing or interpretation.
No
This device is for in vitro diagnostic use, specifically for quantitative point-of-care whole blood hemoglobin determination. It is used to measure a physiological parameter, not to treat or cure a disease or condition.
Yes
The "Intended Use / Indications for Use" section explicitly states, "The HemoCue Hb 301 system is for In Vitro Diagnostic use only."
No
The device description explicitly states the system consists of a physical analyzer (photometer) and microcuvettes, which are hardware components.
Yes, based on the provided text, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section clearly states: "The HemoCue Hb 301 system is for In Vitro Diagnostic use only."
- Nature of the Test: The device is designed for "quantitative point-of-care whole blood hemoglobin determination." This involves analyzing a biological sample (whole blood) outside of the body to provide diagnostic information.
- Components: The system consists of an analyzer and microcuvettes, which are typical components of an in vitro diagnostic device used for sample analysis.
The definition of an In Vitro Diagnostic device generally includes instruments, reagents, and systems intended for use in the diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae. The HemoCue Hb 301 system fits this description by measuring hemoglobin levels in blood, which is a key indicator of health and can be used in the diagnosis and management of various conditions.
N/A
Intended Use / Indications for Use
The HemoCue Hb 301 system is designed for quantitative point-of-care whole blood hemoglobin determination in primary care using a specially designed analyzer, the HemoCue Hb 301 Analyzer, and specially designed microcuvettes, the HemoCue Hb 301 Microcuvettes. The HemoCue Hb 301 system is for In Vitro Diagnostic use only. The HemoCue Hb 301 Analyzer is only to be used with HemoCue Hb 301 Microcuvettes.
Product codes
GKR
Device Description
The HemoCue Hb 301 system consists of a small and portable analyzer (photometer) and plastic microcuvettes. The microcuvette serves both as a pipette and as a measuring cuvette. A blood sample is drawn into the cavity by capillary action. The filled microcuvette is inserted into the HemoCue Hb 301 Analyzer. The measurement takes place in the analyzer, which measures the absorbance of whole blood at a Hb/HbO.isobestic point. The system is factory calibrated and needs no further calibration.
Mentions image processing
Not Found
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
primary care
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Studies were conducted in-house, in clinical laboratory settings and point of care centers to demonstrate the performance of the HemoCue Hb 301 system and that the intended user can easily operate the system and obtain results as expected.
The HemoCue Hb 301 system is a convenient method for measuring whole blood hemoglobin and can be used by typical users and provide clinical results comparable to other test methods in current clinical laboratory and point-of-care practices.
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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 864.5620 Automated hemoglobin system.
(a)
Identification. An automated hemoglobin system is a fully automated or semi-automated device which may or may not be part of a larger system. The generic type of device consists of the reagents, calibrators, controls, and instrumentation used to determine the hemoglobin content of human blood.(b)
Classification. Class II (performance standards).
0
JUN - 8 2006
5.0 510(k) Summary
| Submitter: | HemoCue AB
Box 1204
Ängelholm, Sweden SE-262 23
+46 431 45 82 00 (Telephone)
+46 431 45 82 25 (FAX) |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Mr. Allan White (Official Correspondent)
HemoCue, Inc.
40 Empire Drive
Lake Forest, CA 92630-2244
(949) 859-2630 x110 (Telephone)
(949) 598-8630 (FAX)
allan@hemocue.com |
| Date of Preparation: | April 13, 2006 |
| Proprietary Name: | HemoCue Hb 301 system |
| Classification Name: | Automated and Semi-Automated Hematology Devices,
Automated hemoglobin system (21 CFR § 864.5620),
Product code: GKR |
| Common Name: | Hemoglobin analyzing system |
| Equivalent to: | HemoCue AB claims substantial equivalence to the current legally
marketed HemoCue Hemoglobin 201 system (K032203) |
Description
The HemoCue Hb 301 system consists of a small and portable analyzer (photometer) and plastic microcuvettes. The microcuvette serves both as a pipette and as a measuring cuvette. A blood sample is drawn into the cavity by capillary action. The filled microcuvette is inserted into the HemoCue Hb 301 Analyzer. The measurement takes place in the analyzer, which measures the absorbance of whole blood at a Hb/HbO.isobestic point. The system is factory calibrated and needs no further calibration.
Intended use
The HemoCue Hb 301 system is designed for quantitative point-of-care whole blood hemoglobin determination in primary care using a specially designed analyzer, the HemoCue Hb 301 Analyzer, and specially designed microcuvettes, the HemoCue Hb 301 Microcuvettes. The HemoCue Hb 301 system is for In Vitro Diagnostic use only. The HemoCue Hb 301 Analyzer is only to be used with HemoCue Hb 301 Microcuvettes.
Technological Characteristics
The technological characteristics for HemoCue Hb 301 system are equivalent to the predicate devices. The system consists of an analyzer (photometer) together with microcuvettes. The microcuvette is made of polystyrene plastic and contains no active ingredients. The
1
microcuvette serves both as a pipette and as a measuring cuvette and is for single-use only. A blood sample of approximately 10 uL is drawn into the cavity by capillary action.
The measurement takes place in the analyzer, which measures the absorbance of whole blood at a Hb/HbO2 isobestic point. The analyzer measures at two wavelengths (506 and 880 nm) in order to compensate for turbidity. The HemoCue Hb 301 System is calibrated against the hemiglobincyanide (HiCN) method, the international reference method for the determination of the hemoglobin concentration in blood. The system is factory calibrated and needs no further calibration.
| Claim | Similarities |
|---|---|
| Intended use | Quantitative point-of-care hemoglobin determination in primary care |
| using a specially designed analyzer and specially designed | |
| microcuvettes. The HemoCue systems are for In Vitro Diagnostic | |
| use only. | |
| Result | Quantitative |
| Positioning | Point of Care |
| Analyte | Hemoglobin |
| Specimen | Whole blood |
| Labeling | Equal Directions For Use |
Similarities with predicate device
Assessment of Performance
Studies were conducted in-house, in clinical laboratory settings and point of care centers to demonstrate the performance of the HemoCue Hb 301 system and that the intended user can easily operate the system and obtain results as expected.
Conclusion
The HemoCue Hb 301 system is a convenient method for measuring whole blood hemoglobin and can be used by typical users and provide clinical results comparable to other test methods in current clinical laboratory and point-of-care practices.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The eagle is positioned to the right of a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA".
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JUN - 8 2006
Mr. Allan White Official Correspondent HemoCue, Inc. 40 Empire Drive Lake Forest, CA 92630-2244
K061047 Re:
Trade/Device Name: HemoCue® Hb 301 System Regulation Number: 21 CFR § 864.5620 Regulation Name: Automated hemoglobin system Regulatory Class: II Product Code: GKR Dated: April 13, 2006 Received: April 14, 2006
Dear Mr. White:
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 (OS) 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.
3
Page 2 -
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,
loburtz 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
4
510(k) Number: K061047
Device Name: HemoCue® Hb 301 system
Indications For Use:
The HemoCue Hb 301 system is designed for quantitative point-of-care whole blood hemoglobin determination in primary care using a specially designed analyzer, the HemoCue Hb 301 Analyzer, and specially designed microcuvettes, the HemoCue Hb 301 Microcuvettes. The HemoCue Hb 301 system is for In Vitro Diagnostic use only. The HemoCue Hb 301 Analyzer is only to be used with HemoCue Hb 301 Microcuvettes.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Josephine Bautista
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safery
J(K) K061047
HemoCue® Hb 301 system