(184 days)
K#031472
Yellow Spring Instrument (YSI) 2300 STST Glucose/Lactate Analyzer
No
The description focuses on electrochemical methodology and does not mention AI or ML.
No
The device is an in vitro diagnostic device used to measure glucose levels, which aids in monitoring diabetes control. It does not treat or directly provide therapy.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the device is "intended to be used for quantitative measurement of glucose... as an aid to monitor the effectiveness of diabetes control." Measuring and monitoring a physiological parameter to assist in managing a medical condition like diabetes classifies it as a diagnostic device.
No
The device description explicitly states it is an "in vitro device" and uses "electrochemical methodology" with "electrodes" and measures "current." This indicates the presence of hardware components beyond just software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use Statement: The "Intended Use / Indications for Use" section explicitly states: "It is intended for use outside the body (for in vitro diagnostic use)..."
- Device Description: The "Device Description" further clarifies that it is an "in vitro device designed for measuring the concentration of glucose in capillary whole blood from the fingertip."
- Nature of the Test: The device measures glucose in a biological sample (blood) outside of the body to provide information about a person's health status (diabetes control). This is the core definition of an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Q.STEPS™ Biometer G Blood Glucose Monitoring System is intended to be used for quantitative measurement of glucose in fresh capillary whole blood from the fingertip for all ages (excluding neonates.) It is intended for use outside the body (for in vitro diagnostic use) by health care professionals in settings such as clinical laboratories and physician offices laboratories (POLs) as an aid to monitor the effectiveness of diabetes control.
Product codes
CGA, JJX
Device Description
The Q.STEPS™ Biometer G Blood Glucose Monitoring System is an in vitro device designed for measuring the concentration of glucose in capillary whole blood from the fingertip. The system uses electrochemical methodology. The system quantifies glucose amperometrically by measuring the current that is produced when glucose oxidase catalyzes the oxidation of glucose to gluconic acid. The electrons generated during this reaction are transferred from the blood to the electrodes. The magnitude of the resultant current is proportional to the concentration of glucose in the specimen and is converted to a readout displayed on the monitor.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
fingertip (for capillary whole blood)
Indicated Patient Age Range
all ages (excluding neonates)
Intended User / Care Setting
health care professionals in settings such as clinical laboratories and physician offices laboratories (POLs)
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
Safety: No adverse health effects were observed in the pre-clinical & clinical study. No postclinical trial reports of any health effect were seen.
Linearity: The linearity of the Q.STEPS™ Biometer G System is good through a wide range of 50 to 400 mg/dl. This is confirmed with internal laboratory and external clinical studies.
Accuracy: internal studies and clinical trial method comparison studies showed that the whole blood glucose levels from fingertips determined by Q.STEPS™ System correlated very well with the reference laboratory method, i.e., Yellow Spring Instrument (YSI) 2300 STST Glucose/Lactate Analyzer. All data collected fall well within the acceptance criteria of a bias within 20mg/dl (Blood Glucose
§ 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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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is a symbol that resembles three stylized human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
FEB 2 5 2005
Paul Shieh, Ph.D. President Biomedix, Inc. 40471 Encyclopedia Circle Fremont, CA 94538
Re: K033627
Trade/Device Name: Q.STEPS (TM) Biometer G Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose Test System Regulatory Class: Class II Product Code: CGA, JJX Dated: February 24, 2004 Received: February 25, 2004
Dear Dr. Shieh:
This letter corrects our substantially equivalent letter of May 21, 2004 regarding the incorrect product code of CBA verses the correct product code of CGA - Glucose Oxidase, Glucose.
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval) 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 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General (QS) regulation (21 CFR Part 820) and that, through periodic QS inspections, FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, the Food and Drug Administration (FDA) may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 -
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,
Jean M. Cooper MS DUM
Jean M. Cooper, MS, D.V.M. 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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MAY 2 1 2004
Ko336.27
510 K SUMMARY
| Introduction: | According to the requirements of 21 CFR 807.92, the following information provides
sufficient detail to understand the basis for a determination of substantial
equivalence. |
|-----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter name,
address: | Biomedix, Inc., U.S.A.
40471 Encyclopedia Circle
Fremont, CA 94538 |
| Contact Person: | Judy Shieh Chen, Ph.D.
Phone:(510) 438-9500, ext.414
Fax: (510) 438-9141
E-mail: jchen@biomedixusa.com |
| Date Prepared: | March 29th 2004 |
| Device Name: | Proprietary name:
Q.STEPS™ Biometer G Blood Glucose Monitoring System |
| | Common Name:
Whole Blood Glucose Test System |
| | Classification
- Q.STEPS™ Biometer G and Q.STEPS™ Glucose Test Strip - Class II devices (21
C.F.R. §862.1345, Glucose Test System) - Q.STEPS™ Glucose Control Solution - Class I device (21 C.F.R. §862.1660,
Quality Control Material) - Sterile lancet, Lancing Device and Accessories - Class I (exempt) devices (21
C.F.R. §878.4800, Lancet, Blood). |
| | Classification Name:
Glucose Oxidase, Glucose |
| Predicate Device: | We claim substantial equivalent to the Life Scan OneTouch Basic Blood Glucose
Monitoring System (Test Strips K#031472) |
| Intended Use: | The Q.STEPS™ Biometer G Blood Glucose Monitoring System is intended to be
used for quantitative measurement of glucose in fresh capillary whole blood from the
fingertip for all ages (excluding neonates.) It is intended for use outside the body (for
in vitro diagnostic use) by health care professionals in settings such as clinical
laboratories and physician offices laboratories (POLs) as an aid to monitor the
effectiveness of diabetes control. |
| Test Principle: | The Q.STEPS™ Biometer G Blood Glucose Monitoring System is an in vitro device
designed for measuring the concentration of glucose in capillary whole blood from
the fingertip. The system uses electrochemical methodology. The system quantifies
glucose amperometrically by measuring the current that is produced when glucose
oxidase catalyzes the oxidation of glucose to gluconic acid. The electrons generated
during this reaction are transferred from the blood to the electrodes. The magnitude
of the resultant current is proportional to the concentration of glucose in the
specimen and is converted to a readout displayed on the monitor. |
3
Summary of Performance Studies
Safety
No adverse health effects were observed in the pre-clinical & clinical study. No postclinical trial reports of any health effect were seen.
Linearity
The linearity of the Q.STEPS™ Biometer G System is good through a wide range of The lineanty of the or s . 50 to 400 mg/dl. This is confirmed with internal laboratory and external clinical studies.
Accuracy
internal studies and clinical trial method comparison studies showed that the whole micrhal stadios and others from fingertips determined by Q.STEPS™ System correlated very well with the reference laboratory method, i.e., Yellow Spring Instrument (YSI) 2300 STST Glucose/Lactate Analyzer. All data collected fall well mistiument (101) 2000 oriteria of a bias within 20mg/dl (Blood Glucose