(169 days)
Not Found
No
The description details a photometric system that measures transmittance and calculates glucose levels based on chemical reactions and light absorption, with no mention of AI or ML algorithms.
No
The device is for In Vitro Diagnostic use only, meaning it measures substances in samples from the body to aid in diagnosis and treatment, but it does not directly treat or alter the body.
Yes
The device is used for the "quantitative determination of glucose in whole blood supplementing the clinical evidence in the diagnosis and treatment of patients with diabetes," and is explicitly stated as "for In Vitro Diagnostic use only."
No
The device description explicitly states the system consists of a portable analyzer (photometer) and plastic microcuvettes, which are hardware components.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section explicitly states: "The HemoCue Glucose 201 RT system is for In Vitro Diagnostic use only."
- Nature of the Test: The device performs a "quantitative determination of glucose in whole blood." This is a laboratory test performed on a biological sample (blood) outside of the body, which is the definition of an in vitro diagnostic test.
- Device Description: The description details how the device analyzes a blood sample using reagents and a photometer, further confirming its function as an in vitro diagnostic tool.
N/A
Intended Use / Indications for Use
The HemoCue Glucose 201 RT system is used for quantitative determination of glucose in whole blood supplementing the clinical evidence in the diagnosis and treatment of patients with diabetes. The HemoCue Glucose 201 RT system is for In Vitro Diagnostic use only. The HemoCue Glucose 201 RT Analyzer is only to be used with HemoCue Glucose 201 RT Microcuvettes. For professional use only.
Product codes
LFR
Device Description
The HemoCue Glucose 201 RT system consists of a small and portable analyzer (photometer) and plastic microcuvettes. The HemoCue Glucose 201 RT Microcuvette contains reagents deposited on its inner walls and serves both as a pipette and as a measuring cuvette. A blood sample of approximately 4 uL is drawn into the cavity by capillary action. The filled microcuvette is inserted into the HemoCue Glucose 201 RT Analyzer. The measurement takes place in the analyzer in which the transmittance is measured and the absorbance and glucose level is calculated.
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
professional use only. / in clinical laboratory settings and point of care centers
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 Glucose 201 RT system and that the intended user can easily operate the system and obtain results as expected.
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
§ 862.1345 Glucose test system.
(a)
Identification. A glucose test system is a device intended to measure glucose quantitatively in blood and other body fluids. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.(b)
Classification. Class II (special controls). The device, when it is solely intended for use as a drink to test glucose tolerance, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
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SEP -6 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
(800) 881-1611 x110 (Telephone)
(949) 859-3066 (FAX)
allan@hemocue.com |
| Date of Preparation: | March 17, 2006 |
| Proprietary Name: | HemoCue Glucose 201 RT system |
| Classification Name: | Glucose Dehydrogenase, Glucose test system (21 CFR §
862.1345), Product code: LFR |
| Common Name: | HemoCue Glucose 201 RT system |
| Equivalent to: | HemoCue AB claims substantial equivalence to the current legally
marketed HemoCue Glucose 201 system (K020935) |
Description
The HemoCue Glucose 201 RT system consists of a small and portable analyzer (photometer) and plastic microcuvettes. The HemoCue Glucose 201 RT Microcuvette contains reagents deposited on its inner walls and serves both as a pipette and as a measuring cuvette. A blood sample of approximately 4 uL is drawn into the cavity by capillary action. The filled microcuvette is inserted into the HemoCue Glucose 201 RT Analyzer. The measurement takes place in the analyzer in which the transmittance is measured and the absorbance and glucose level is calculated.
Intended use
The HemoCue Glucose 201 RT system is used for quantitative determination of glucose in whole blood supplementing the clinical evidence in the diagnosis and treatment of patients with diabetes. The HemoCue Glucose 201 RT system is for In Vitro Diagnostic use only. The HemoCue Glucose 201 RT Analyzer is only to be used with HemoCue Glucose 201 RT Microcuvettes. For professional use only.
Technological Characteristics
The technological characteristics for HemoCue Glucose 201 RT system are equivalent to the predicate device. The system consists of an analyzer together with microcuvettes. The microcuvette serves both as a pipette and as a measuring cuvette and is for single-use only. A
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blood sample of approximatly 4 µL is drawn into the cavity by capillary action. The chemical reaction in the cavity of the HemoCue Glucose 201 RT microcuvettes has two phases, hemolysis and the glucose reaction. The glucose reaction is a modified glucose dehydrogenase method in which a tetrazolium salt (MTT) is used to obtain a quantification of glucose in visible light. B-D-glucose is transformed to B-D-glucose using mutarotase. Glucose dehydrogenase acts as a catalyst for the oxidation of B-D-glucose, to form NADH, which in the presence of diaphorase produces a colored formazan with MTT. The measurement takes place in the analyzer in which the transmittance is measured and the absorbance and glucose level is calculated. The calibration of the HemoCue Glucose 201 RT system is traceable to the ID GC-MS method. The HemoCue Glucose 201 RT is factory calibrated and needs no further calibration.
| Claim | Similarities |
|---|---|
| Intended use | The HemoCue Glucose 201 RT and HemoCue Glucose 201 systems |
| are designed for quantitative determination of glucose in whole | |
| blood (capillary, venous or arterial blood). Both devices are for | |
| professional use only. Both devices are for In Vitro Diagnostic use | |
| only. | |
| Test principle | Modified glucose dehydrogenase reaction |
| Result | Quantitative |
| Positioning | Point of Care |
| Operating | |
| temperature | 59°F - 86°F(15°C - 30°C) |
| Labeling | Equal Directions For Use |
| Labeling | |
| expected results | Fasting glucose values (reference interval): Plasma glucose, adults |
| 74-106 mg/dL (4.5-5.9 mmol/L). | |
| For diagnosis of diabetes mellitus, follow local recommendations or | |
| use the following value according to WHO and ADA: Fasting | |
| plasma glucose, capillary or venous ≥126 mg/dL (≥7.0 mmol/L). | |
| Quality control | |
| testing | No external quality control testing is necessary. The systems have an |
| internal self-test. |
Assessment of Performance
Studies were conducted in-house, in clinical laboratory settings and point of care centers to demonstrate the performance of the HemoCue Glucose 201 RT system and that the intended user can easily operate the system and obtain results as expected.
Conclusion
The HemoCue Glucose 201 RT system is a convenient method for measuring blood glucose 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.
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" are arranged in a circular pattern around the eagle. The logo is black and white and has a simple, clean design.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
HemoCue AB c/o Mr. Allan White Quality System Manager HemoCue, Inc. 40 Empire Dr. Lake Forest, CA 92630-2244
SEP - 6 2006
Re: K060765
Trade/Device Name: HemoCue® Glucose 201 RT system Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: LFR Dated: August 14, 2006 Received: August 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 (QS) regulation (21 CFR Part 820).
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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.
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,
Alberto Gutierrez, Ph.D.
Alberto Gutierrez, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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510(k) Number: K060765
Device Name: HemoCue® Glucose 201 RT system
Indications For Use:
The HemoCue Glucose 201 RT system is used for quantitative determination of glucose in whole blood supplementing the clinical evidence in the diagnosis and treatment of patients with diabetes. The HemoCue Glucose 201 RT system is for In Vitro Diagnostic use only. The HemoCue Glucose 201 RT Analyzer is only to be used with HemoCue Glucose 201 RT Microcuvettes. For professional use only.
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)
Division Sign-Off
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K060765
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