(63 days)
Not Found
No
The description focuses on amperometric biosensor technology and does not mention AI or ML.
No
This device is a diagnostic tool used to measure glucose levels, which helps in monitoring diabetes mellitus, but it does not directly treat or provide therapy.
Yes
The document states that the device is "intended for in vitro diagnostic use" and "quantitatively measures glucose (D-glucose) in fresh neonatal, venous, arterial and fingertip capillary whole blood" to "monitor diabetes mellitus". This directly aligns with the definition of a diagnostic device.
No
The device is a blood glucose test strip, which is a physical component used with a meter to measure glucose. It is not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section explicitly states: "The Precision/Optium Point of Care Blood Glucose Test Strip with True Measure Technology is intended for in vitro diagnostic use."
- Nature of the Test: The device measures glucose in blood samples, which is a classic example of an in vitro diagnostic test. It analyzes a biological sample outside of the body to provide information about a patient's health status.
- Intended Use: The intended use is for "monitoring diabetes mellitus," which is a diagnostic and monitoring purpose.
The other sections of the document further support this by describing the technology used to analyze the blood sample and the intended user and setting, all consistent with an IVD.
N/A
Intended Use / Indications for Use
The Precision/Optium Point of Care Blood Glucose Test Strip with True Measure Technology is intended for in vitro diagnostic use. The test strip quantitatively measures glucose (D-glucose) in fresh venous. arterial, neonatal, and fingertip capillary whole blood. The test strip is indicated for use by health care professionals in health care settings. This strip may be used with the Precision Xtra/Optium Blood Glucose Meters.
Product codes
LFR
Device Description
The Precision/Optium Point of Care Blood Glucose Test Strips with True Measure Technology is to be used for blood glucose testing with the Precision Xtra/Optium and Precision PCx Blood Glucose Meters. These systems utilize amperometric biosensor technology to generate a current. The size of the current is proportional to the amount of glucose present in the sample, providing a quantitative measure of glucose in fresh whole blood and control solutions.
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
neonatal
Intended User / Care Setting
health care professionals in health care settings
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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The performances of the Precision/Optium Point of Care Blood Glucose Test Strip with True Measure Technology was studied in the laboratory and in clinical settings by healthcare professionals. The studies demonstrated that healthcare professionals could obtain blood glucose results that are substantially equivalent to a comparative method.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Accu-Chek Comfort Curve Test Strip K980731
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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Modified Precision Xtra/MediSense Optium Blood Glucose Test Strip Neonatal, venous and arterial claims Volume I of I 510(k) Notification 13-June-2002
Summary of Safety and Effectiveness
Submitted by: Janet Connolly, RAC Senior Regulatory Affairs Specialist Abbott Laboratories, MediSense Products 4A Crosby Drive Bedford, MA 01730-6230
Device Name: Precision/Optium Point of Care Blood Glucose Test Strips with True Measure Technology
Common Name: Reagent Blood Glucose Test Strip
Classification: Glucose Test System Class II per 21 CFR 862.1345
Predicate Device: Accu-Chek Comfort Curve Test Strip K980731
Description: The Precision/Optium Point of Care Blood Glucose Test Strips with True Measure Technology is to be used for blood glucose testing with the Precision Xtra/Optium and Precision PCx Blood Glucose Meters. These systems utilize amperometric biosensor technology to generate a current. The size of the current is proportional to the amount of glucose present in the sample, providing a quantitative measure of glucose in fresh whole blood and control solutions.
Intended Use: The Precision/Optium Point of Care Blood Glucose Test Strip with True Measure Technology is intended for in vitro diagnostic use. The test strip quantitatively measures glucose (D-glucose) in fresh venous. arterial, neonatal, and fingertip capillary whole blood. The test strip is indicated for use by health care professionals in health care settings,
This strip may be used with the Precision Xtra/Optium Blood Glucose Meters.
Comparison to The Precision/Optium Point of Care Blood Glucose Test Strip has Predicate Device: similar technological characteristics as the predicate device, Accu-Chek Comfort Curve Test Strip K980731.
1
| Performance
Studies: | The performances of the Precision/Optium Point of Care Blood
Glucose Test Strip with True Measure Technology was studied in the
laboratory and in clinical settings by healthcare professionals. The
studies demonstrated that healthcare professionals could obtain blood
glucose results that are substantially equivalent to a comparative
method. |
|-------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Conclusion: | Results of laboratory and clinical testing demonstrate that the
performance of the Precision/Optium Point of Care Blood Glucose
Test Strips when used according to the intended use stated above is
acceptable and comparable to the performance to a comparative
method. |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three wing-like shapes. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
AUG 1 6 2002
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Janet Connolly, RAC Sr. Regulatory Affairs Specialist Abbott Laboratories, MediSense Products 4A Crosby Drive Bedford, MA 01730-1402
Re: K021960
Trade/Device Name: Abbott Laboratories, MediSense Products Precision Point of Care Blood Glucose Test Strips with True Measure Technology Abbott Laboratories, MediSense Products Optium Point of Care Blood Glucose Test Strips with True Measure Technology Regulation Number: 21 CFR 862.1345
Regulation Name: Glucose test system Regulatory Class: Class II Product Code: LFR Dated: June 13, 2002 Received: June 14, 2002
Dear Ms. Connolly:
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 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 comply 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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Page 2 -
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 1 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/cdrl/dsmaldsmamain.html".
Sincerely yours,
Steven Putman
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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INDICATIONS FOR USE FORM 510(k) Number (if known):
Abbott Laboratories, MediSense Products Precision Point of Care Device Name: Blood Glucose Test Strips with True Measure Technology.
Abbott Laboratories, MediSense Products Optium Point of Care Blood Glucose Test Strips with True Measure Technology
Indications For Use:
The Precision/Optium Point of Care Blood Glucose Test Strip with True Measure Technology is intended for in vitro diagnostic use. The test strip quantitatively measures glucose (D-glucose) in fresh neonatal, venous, arterial and fingertip capillary whole blood. The test strip is indicated for use by health care professionals in health care facilities. The test strip is to be used for monitoring diabetes mellitus.
This strip may be used with the Precision Xtra and Optium meters.
Nherts Znting for Jean Cooper
Division Sign Off
vision of Clinical Laboratory Devices 510(k) Number
(PLEASE DO NOT WRITE BELOW THIS LINE--CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Or
Prescription Use (Per 21 CFR 801.108)
Over-The-Counter Use