(194 days)
The Q.STEPS Biometer G/C Dual Monitoring System is intended for use with Q.STEPS Glucose and Cholesterol Test Strips with Q.STEPS Biometer G/C System by healthcare professionals and home users. Q.STEPS Biometer G/C System provides a quantitative measurement of Glucose and Cholesterol in whole blood from the fingertips. The Glucose measurements are used in helping the management of carbohydrate metabolism disorders including diabetes mellitus, idiopathic hypoglycemia and pancreatic islet cell tumors. Cholesterol measurements are used in the management of disorders involving excess cholesterol in the blood, lipid and lipoprotein metabolism disorders.
The Q. STEPS™ Biometer G/C Dual Monitoring System uses enzymatic electrochemical biosensor technology for a quick and easy measurement of the whole blood glucose and cholesterol levels. When finger stick blood is applied to the test spot of the biosensor (test strip), a reduction oxidation reaction of D-Glucose or Cholesterol occurs, which is catalyzed by Glucose Oxidase and Cholesterol Oxidase respectively, and therefore, the magnitude of the electron transfer at the electrode is proportional to the glucose or cholesterol concentration in the blood. The monitor will quantify the glucose and the cholesterol levels in the blood, and then display on the readout of the monitor.
The provided 510(k) summary for the Q.STEPS™ Biometer G/C Dual Monitoring System does not contain the detailed information necessary to fully answer all aspects of your request regarding acceptance criteria and the comprehensive study that proves the device meets those criteria. The summary focuses primarily on device description, classification, predicate devices, and intended use, rather than a detailed performance study report.
However, based on the available information regarding the device's function (measuring glucose and cholesterol), and common practices for such devices, we can infer some general acceptance criteria and discuss the provided information.
Here's an attempt to structure the answer based on the prompt and the limited information:
1. A table of acceptance criteria and the reported device performance
The provided document does not explicitly state specific acceptance criteria in terms of numerical accuracy targets (e.g., +/- 15% for glucose, specific bias, precision values). It also does not report detailed device performance data from a specific study.
For a glucose and cholesterol meter, typical acceptance criteria, often outlined in standards like ISO 15197 for blood glucose monitoring systems, would include:
| Metric (Inferred) | Acceptance Criteria (Inferred from industry standards) | Reported Device Performance (Not explicitly stated in this document) |
|---|---|---|
| Glucose Measurement | ||
| Accuracy (vs. Lab Ref.) | e.g., >95% of results within ±15 mg/dL or ±15% | Not reported |
| Repeatability (Precision) | e.g., CV < 5% | Not reported |
| Intermediate Precision | e.g., CV < 7% | Not reported |
| Sample Volume | e.g., Small sample volume required | Not reported, but implied by "quick and easy measurement" |
| Test Time | e.g., < 30 seconds | Implied "quick" measurement |
| Cholesterol Measurement | ||
| Accuracy (vs. Lab Ref.) | e.g., Specific bias and precision limits | Not reported |
| Repeatability (Precision) | e.g., CV < 10% | Not reported |
| Intermediate Precision | e.g., CV < 15% | Not reported |
| Sample Volume | e.g., Small sample volume required | Not reported, but implied by "quick and easy measurement" |
| Test Time | e.g., < 2 minutes | Implied "quick" measurement |
| User Studies | Demonstrate usability for intended users | Not reported |
Note: The 510(k) summary typically includes a performance section with such data, but it is missing from the provided extract. The approval (K050182) indicates that such data were reviewed by the FDA, but they are not included in this summary.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the given 510(k) summary. A typical submission would include details about clinical study sample sizes, patient demographics, and the prospective or retrospective nature of the data collection, as well as the study sites (country of origin).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided in the given 510(k) summary. For device performance validation, ground truth for glucose and cholesterol measurements would typically come from a central, certified clinical laboratory using a reference method (e.g., hexokinase method for glucose, enzymatic methods for cholesterol on a clinical chemistry analyzer). The "experts" would be the certified lab technicians and clinical pathologists overseeing these reference measurements, not typically individual radiologists.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable in the context of a blood glucose/cholesterol meter's performance study. Adjudication methods like 2+1 are relevant for subjective interpretations (e.g., imaging studies) where multiple readers assess and resolve discrepancies. For quantitative measurements, the ground truth is established by a reference laboratory method, not by expert consensus on the device's readings.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This is not applicable to the Q.STEPS™ Biometer G/C Dual Monitoring System. This device is a standalone measurement system, not an AI-assisted diagnostic tool that aids human readers in interpreting images or complex data. Therefore, an MRMC study comparing human performance with and without AI assistance would not be relevant.
6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done
Yes, the performance evaluation for this device is inherently a standalone performance study. The device measures glucose and cholesterol levels; its accuracy and precision are assessed independently against reference laboratory methods. There is no "human-in-the-loop" in the sense of the algorithm providing an interpretation that a human then uses. The human simply uses the device and reads the displayed result.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for this device's performance study would be based on reference laboratory methods for glucose and cholesterol. Specifically:
- Glucose: Likely measured using a reference method such as the hexokinase method on a certified clinical chemistry analyzer.
- Cholesterol: Likely measured using an enzymatic reference method on a certified clinical chemistry analyzer.
This is the standard for evaluating the accuracy of point-of-care or home-use blood chemistry devices.
8. The sample size for the training set
This information is not provided in the given 510(k) summary. For electrochemical biosensors, concept of a "training set" in the context of machine learning isn't directly applicable in the same way as for an AI algorithm. However, significant calibration and validation data would be collected during the device's development and manufacturing. If the manufacturer used advanced algorithms for signal processing that could be "trained" or optimized, data for such a process would exist but is not detailed here.
9. How the ground truth for the training set was established
As described above, for a device like this, the "ground truth" for any calibration or validation would be established by comparison to reference laboratory methods (e.g., hexokinase for glucose, enzymatic methods for cholesterol). This ensures that the device's measurements correlate accurately with established clinical standards.
In summary, the provided 510(k) summary extract is a high-level overview and does not contain the detailed performance study information requested. Such information would typically be found in a separate, more comprehensive performance study report that accompanies the 510(k) submission but is not part of this "summary" document.
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510(K) Summary
This summary of safety and effectiveness information is submitted in compliance with 21CFR 807.92.
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- Application Date: November 30, 2004
AUG 0 9 2005
- Application Date: November 30, 2004
2. Applicant Information:
Biomedix Inc., USA 40471 Encyclopedia Circle, Fremont, CA 94538 Establishment Registration No.: 3004525092
Contact Person:Paul K Shieh, Ph.D Judy S. Chen, Ph.D. Phone Number: 510-438-9500 ext 401, 405 510-366-8270 (Cell) 510-449-1554 (Cell) 510-438-9141 Fax Number: ShiehPaul @Yahoo.com e-mail: jchen@biomedixusa.com
3. Trade Names:
Q.STEPS™ Biometer G/C Dual Monitoring System
Device Description: ধ:
The Q. STEPS™ Biometer G/C Dual Monitoring System uses enzymatic electrochemical The Q. OTEL O - Blomotor OF Blan easy measurement of the whole blood glucose and blosensor technology for a quier and is applied to the test spot of the biosensor (test cholesterol levels. When inger sist occurs. The oxidation of D-Glucose or Cholesterol sthp), a reduction oxidation room of Cholesterol Oxidase respectively, causes which is cataly.cod by Oldooo extraces; and therefore, the magnitude of the an electron transfer at the glucose or cholesterol concentration in the blood. current produced is propertional to the guantify the glucose and the cholesterol levels in the blood , and then display on the readout of the monitor.
5. Classification Name:
Cholesterol test system Glucose test system Product Codes: CHH, CGA
Device Classification: 6.
- Q.STEPS™ Biometer G/C and Glucose Test Strips Class II devices (21 C.F.R. 1. 5862.1345, Glucose Test System)
- Q.STEPS™ Biometer G/C and Cholesterol Test Strips Class I devices (21 C.F.R. 2. §862.1175, Cholesterol Test System)
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7. Intended Use
The Q STEPS Biometer G/C Dual Monitoring System is intended for use with Q STEPS Glucose and Cholestero! Test Strips with Q.STEPS Biometer G/C by healthcare professionals and home users. Q.STEPS Biometer G/C, System provides a quantitative measurement of Glucose and Cholesterol in whole blood from the fingertips. The Glucose measurements are used in helping the management of carbohydrate metabolism disorders including diabetes mellitus, idiopathic hypoglycemia and pancreatic islet cell tumors. Cholesterol measurements are used in the management of disorders involving excess cholesterol in the blood, lipid and lipoprotein metabolism disorders.
8. Reason for 510K
New Device application of 510K Clearance
9. Predicate Devices
The predicate devices for determination of Substantial Equivalence are:
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- Q STEPS™ Biometer G Blood Glucose Monitoring System (K033627)
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- Polymer Technology Systems, Inc., PTS PANELS Lipid Panel Test Strips (K023558))
- One Touch Basic/Profile/One Touch II Test Strips, LifeScan, Inc.(K031472) ని.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with a serpent entwined around it. The symbol is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.
AUG 9 - 2005
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Judy S. Chen, Ph.D. Consultant Biomedix, Inc. 40471 Encyclopedia Circle Fremont CA, 94538
K050182 Re:
R050102
Trade/Device Name: Q.STEPS Biometer G/C Dual Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: NBW, CGA, CHH, JJX Dated: May 12, 2005 Received: May 16, 2005
Dear Dr. Chen:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roved your cover your colermined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreated of the enactment date of the Medical Device Amendments, or to conimered pror co rial) 2011-12-11 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). and Cosmetic receive, market the device, subject to the general controls provisions of the Act. The I va may, morelore, manso 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 your device to such additional controls. Existing major regulations affecting your device it may be subject to back adon and 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 I loase be actived a determination that your device complies with other requirements of the Act than I Drederal statutes and regulations administered by other Federal agencies. You must or any I vith 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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Page 2 -
This letter will allow you to begin marketing your device as described in your Section 510(k)
The success of the support of any for the first of section of your device to lle i his letter will anow you to ocgin nativeling your antial equivalence of your device to a legally
premarket notification. The FDA finding of substantial equivales and thus, premarket notification. The FDA induitg of substantal of the most of the may be device to proceed to the market.
If you desire specific information about the application of labeling requirements to your device, af In If you desire specific information acount in appear the spease contact the Office of In
or questions on the promotion and advertising of your and and and and also, mass note of questions of the promotion and advertising of your . Also, please note the Vito Diagnostic Device Livanation and Barco ... (----------------------------------------------------------------------------------------------------------------------------fegulation entitled, "Misoranant of Telection on your responsibilities under the Act from the You may obtain other general information on your respected 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,
Carol C. Benam
Carol C. Benson, M.A. Acting 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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ATTACHMENT 4 Indications for Use
510(k) Number:
Device Name:
K 050182
Q. STEPS Biometer G/C Dual Monitoring System
Indications: For Use:The Q.STEPS Biometer G/C Dual Monitoring System is intended
Indications: For States of Chalasterel Tost Strips with O STEPS Biometer Indications: For Use: The Q.STEPS Blonneter O/O Dualtining eyes Biometer
for use with Q.STEPS Glucose and Cholesterol Test Strips with Q.STEPS Biometer G/C System for use with Q.STEPS Glucose and Unblesterer rest Stipb min and Children G/C System.
G/C by healthcare professionals and home users. Q.STEPS Biometer G/C System. G/C by healthcare professionals and home users. provides a quantitative measurement of charity of the management of
the fingertips. The Glucose measurements are used in helping the management the fingertips. The Glucose measurements are used in new on one of one of the finger in the carbohydrate metabolism disolutions massurements are used in the and pancreatic islet cell tumors. Cholesterol measurements are associations and lipoprotein
management of disorders involving excess cholesterol in the blood, lipid and lipo metabolism disorders.
Prescription Use __ (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter (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 Devices (OIVD)
Alberto Su
Division Sign-Off
Page 1 of of _________________________________________________________________________________________________________________________________________________________________
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K050182
§ 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.