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.

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.

AI/ML Overview

Here's an analysis of the acceptance criteria and study detailed in the provided document for the Q.STEPS™ Biometer G Blood Glucose Monitoring System:

1. Table of Acceptance Criteria and Reported Device Performance

Performance Metric	Acceptance Criteria (Explicitly Stated or Implied by Context)	Reported Device Performance
Linearity	Good linearity through a wide range (implied to be clinically relevant for glucose monitoring)	Good through a wide range of 50 to 400 mg/dl. Confirmed with internal laboratory and external clinical studies.
Accuracy (Agreement with Reference Method)	Bias within 20 mg/dl (for Blood Glucose < 100 mg/dl) or within 20% (for Blood Glucose ≥ 100 mg/dl) on the reference method. >95% (or similar high percentage) in Zones A & B of Clarke Error Grid.	All data collected fall well within the acceptance criteria of a bias within 20 mg/dl (Blood Glucose < 100 mg/dl) or within 20% (Blood Glucose ≥ 100 mg/dl) on the reference method. Over 98% of all clinical data fall into acceptable zones A & B in the Clarke Error Grid analysis.
Precision (CV Values)	CV values well within 8% (for commercial controls and spiked venous whole blood specimens).	Standard deviation values are very low and CV values are well within the acceptance criteria of less than 8%.
Stability (Shelf Life of Test Strips)	Provides constant glucose reading over time for its intended shelf life.	Test strips provide a constant glucose reading over time. Accelerated stability evaluation determines an approximate shelf life of 2 years.
Hematocrit Interference	Within ±20% of the glucose concentration determined with a set of hematocrit standard (45±3%).	Hematocrit levels of 30% to 60% are acceptable for use with the system, meeting the acceptance criteria of ±20% of the glucose concentration determined with a set of hematocrit standard (45±3%).
Interference Substances	No interference observed at physiological/therapeutic levels for common substances. Limited or no interference observed at higher dosages where clinically acceptable.	No interference observed in Bilirubin, Cholesterol, Creatinine, Citrate (at physiological levels, except Uric Acid), Ibuprofen, Aspirin, Tetracycline, EDTA, D-Galactose, K3Fe(CN)6, D-Mannose, D-Xylose, and Maltose. Some interference observed at higher dosages of Acetaminophen, Ascorbic Acid, L-Dopa, Dopamine, Methyldopa, and Tolazamide, but implied to be acceptable within context.
Safety	No adverse health effects observed.	No adverse health effects were observed in the pre-clinical & clinical study. No post-clinical trial reports of any health effect were seen.

2. Sample Size Used for the Test Set and the Data Provenance

Test Set Sample Size:
- Accuracy: Not explicitly stated as a single number. The document mentions "clinical trial method comparison studies" and "all clinical data," but doesn't provide a specific number of subjects or samples tested for accuracy.
- Precision:
  - Commercial Controls: 2 runs/day x 2 readings/run x 2 biometers x 20 days = 160 readings per control level. (Number of control levels not specified).
  - Venous Whole Blood: 20 readings per concentration for five different concentrations. So, 20 readings x 5 concentrations = 100 readings.
- Hematocrit Interference: Not explicitly stated; mentions "tested within the hematocrit range from 30% to 60%" and "a set of hematocrit standard (45±3%)."
- Interference Substances: "Twenty-three commonly tested interference substances were examined." The number of samples per substance is not stated.
- Linearity & Stability: No specific sample sizes provided.
Data Provenance: The document does not specify the country of origin. The studies involve both "internal laboratory" and "external clinical studies/trial." This suggests a combination of prospective (clinical trials) and retrospective (internal lab data, possibly from existing samples) data, but the specific breakdown is unclear.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

This information is not provided in the document. The document describes accuracy relative to a "reference laboratory method," but does not mention human experts establishing ground truth or their qualifications.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method for establishing ground truth. The ground truth for glucose measurements is established by a reference instrument (YSI 2300 STST Glucose/Lactate Analyzer), not through expert adjudication of images or clinical cases.

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

A Multi-reader Multi-case (MRMC) comparative effectiveness study is not applicable and was not performed as this device is a standalone blood glucose monitoring system, not an AI-assisted diagnostic tool that aids human readers in interpreting results.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

Yes, the performance studies described are for the device (Q.STEPS™ Biometer G Blood Glucose Monitoring System) operating in a standalone mode (algorithm only) measuring glucose concentrations. While a human uses the device and interprets the displayed result, the performance metrics (accuracy, precision, linearity, etc.) refer to the direct output of the instrument compared to a reference standard, without any human interpretation influencing the measurement itself.

7. The Type of Ground Truth Used

The ground truth for glucose concentration measurements was established by a reference laboratory method, specifically the Yellow Spring Instrument (YSI) 2300 STST Glucose/Lactate Analyzer.

8. The Sample Size for the Training Set

The document does not explicitly mention a "training set" in the context of machine learning or AI. This device relies on electrochemical principles and a pre-defined algorithm, not a trainable machine learning model. Therefore, the concept of a training set for an AI algorithm is not applicable here. The internal laboratory studies and initial development likely involved various samples to calibrate and refine the device's measurement algorithm, but these are not explicitly referred to as a "training set."

9. How the Ground Truth for the Training Set Was Established

As the device does not employ a machine learning algorithm with a "training set" in the conventional sense, this question is not applicable. The underlying physical and chemical principles and algorithms are based on established scientific methods for glucose detection, and the "ground truth" during development/calibration would have been established using highly accurate reference methods like the YSI 2300 or similar laboratory-grade analyzers.

Summary

{0}------------------------------------------------

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.

{1}------------------------------------------------

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

{2}------------------------------------------------

MAY 2 1 2004

Ko336.27

510 K SUMMARY

Introduction:	According to the requirements of 21 CFR 807.92, the following information providessufficient detail to understand the basis for a determination of substantialequivalence.
Submitter name,address:	Biomedix, Inc., U.S.A.40471 Encyclopedia CircleFremont, CA 94538
Contact Person:	Judy Shieh Chen, Ph.D.Phone:(510) 438-9500, ext.414Fax: (510) 438-9141E-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
	Classification1. Q.STEPS™ Biometer G and Q.STEPS™ Glucose Test Strip - Class II devices (21C.F.R. §862.1345, Glucose Test System)2. Q.STEPS™ Glucose Control Solution - Class I device (21 C.F.R. §862.1660,Quality Control Material)3. Sterile lancet, Lancing Device and Accessories - Class I (exempt) devices (21C.F.R. §878.4800, Lancet, Blood).
	Classification Name:Glucose Oxidase, Glucose
Predicate Device:	We claim substantial equivalent to the Life Scan OneTouch Basic Blood GlucoseMonitoring System (Test Strips K#031472)
Intended Use:	The Q.STEPS™ Biometer G Blood Glucose Monitoring System is intended to beused for quantitative measurement of glucose in fresh capillary whole blood from thefingertip for all ages (excluding neonates.) It is intended for use outside the body (forin vitro diagnostic use) by health care professionals in settings such as clinicallaboratories and physician offices laboratories (POLs) as an aid to monitor theeffectiveness of diabetes control.
Test Principle:	The Q.STEPS™ Biometer G Blood Glucose Monitoring System is an in vitro devicedesigned for measuring the concentration of glucose in capillary whole blood fromthe fingertip. The system uses electrochemical methodology. The system quantifiesglucose amperometrically by measuring the current that is produced when glucoseoxidase catalyzes the oxidation of glucose to gluconic acid. The electrons generatedduring this reaction are transferred from the blood to the electrodes. The magnitudeof the resultant current is proportional to the concentration of glucose in thespecimen 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 <100mg/dl) or whillin the assopeanse on the reference method. Furthermore, over 98% of all clinical data fall into acceptable zones A & B in the Clarke Error Grid analysis.

Precision

Precision evaluation performed in the internal laboratory and clinical environment shows that the Q.STEPS™ System can determine very precise glucose concentrations. For commercial controls, readings were taken twice in the morning (Run1) and twice in the evening (Run2). Each reading obtained from each run was taken from two different Q.STEPS™ Biometers. This was performed every day for 20 consecutive days. For venous whole blood specimens spiked with five different 20 concentrations of glucose, 20 readings were taken from each concentration on the same day. Overall, the standard deviation values are very low and CV values are well within the acceptance criteria of less than 8%.

Stability

In both room temperature and accelerated stability studies, the Q.STEPS™ Test Strips provide a constant glucose reading over time. From the accelerated stability evaluation, the Q.STEPS™ Test Strips have been determined to have an approximate shelf life of 2 years.

Hematocrit Interference

The degree of the hematocrit effect depends on the glucose concentration. The Q.STEPS™ System was tested within the hematocrit range from 30% to 60%. With an acceptance criteria of ±20% of the glucose concentration determined with a set of hematocrit standard (45+3%), the results of this study show that hematocrit levels of 30% to 60% is acceptable for use with the Q.STEPS™ Biometer G System.

Interference Substances

Twenty-three commonly tested interference substances were examined in . this study. No interference was observed in the Bilirubin, Cholesterol, Creatinine and Citrate at physiological levels except for Uric Acid.
No interference was observed in the Ibuprofen, Aspirin and Tetracycline. .
No interference was observed at therapeutical ranges of Acetaminophen, . Ascorbic Acid (Vit.C.), L-Dopa, Dopamine, Methyldopa and Tolazamide. Some interference was observed at higher dosages of these compounds.
No interference was observed in EDTA (in blood drawing tubes), D-. Galactose, K3Fe (CN)g, D-Mannose, D-Xylose and Maltose.

{4}------------------------------------------------

Indications for Use

510(k) Number (if known): K033627

Device Name: Q.STEPS

Indications For Use:

The Q.STEPS™ Biometer G Blood Glucose Monitoring System is intended to be used for quantitative
s and the security of a free been ill muchale hood from the fingerin for all a The Q.STEPS™ Biometer G Blood Glocker in the finger in for all ages (excluding neonates.) It is measurement of glucose in tresh opliary who included in an artisesionals in sgrings such as
intended for use outside the body (for in vitro diagnostic use professionals in s intended for use outside the body (for in vitro diagnosic use) by health on a subcontrol.

Ruth A. Clarke (for Carol Benson)

I)ivision Sign-C

office of In Vitro Diagnostic Devi Svaluation and Safety

$\sin(k) \frac{k_{0}33627}{/}$

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of ____________________________________________________________________________________________________________________________________________________________________

Regulation Number and Section

§ 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.