(119 days)
The Glucose Pilot Blood Glucose monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood from a finger stick, for the lay-user. It is also intended for the professional use, which include fresh capillary whole blood. It is intended for use outside the body (in vitro diagnostic use) by people with diabetes mellitus at home as an aid in monitoring the effectiveness of a diabetes control program. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.
The Glucose Pilot Glucose monitoring System consists of a hand-held blood glucose meter, test strips, lancing device, lancets, and two levels of control solution. The test strip has a lot - specific calibration information and the meter reads automatically. The meter is turned on by inserting the strip, the user supplies the capillary blood or control solution, the meter makes an audible tone and starts the assay, which completes in five seconds. The meter's software converts the results read off the test strip into a plasma glucose concentration and displays the value on the meter's display. The provided instructions and illustrations explaining that the blood drop will be pulled into the strip sample entry by capillary action. Results are stored in the meter's memory for tracking purposes.
Here's an analysis of the provided text to extract the requested information about acceptance criteria and the device study:
Important Note: The provided document is a 510(k) summary for a blood glucose monitoring system. These typically focus on demonstrating substantial equivalence to a predicate device rather than presenting a full clinical study with detailed performance metrics against defined acceptance criteria in the same way a novel high-risk device might. Consequently, some of the requested information (especially regarding expert adjudication, MRMC studies, explicit acceptance criteria with pre-defined ground truth for this specific device's performance claims) is not explicitly stated in this type of document. I will extract what is available and highlight where information is absent due to the nature of the submission.
Acceptance Criteria and Device Performance
The document doesn't explicitly list a table of acceptance criteria with corresponding device performance metrics in the format you requested for a complex diagnostic device. Instead, it focuses on demonstrating substantial equivalence to an existing predicate device (Ultra One Touch Glucose Monitoring System). The "acceptance criteria" in this context are implicitly that the new device performs similarly or equivalently to the predicate device across various characteristics and specifications.
However, based on the Comparison to Predicate Device(s) table, we can infer performance specifications that the new device aims to meet or match.
1. Table of Acceptance Criteria and the Reported Device Performance
Since explicit "acceptance criteria" are not given, I will present the key performance specifications listed for the new device as its "reported device performance" and the corresponding values from the predicate device as an indication of the expected or "accepted" range for similar devices.
| Characteristic / "Acceptance Criteria" (Implied by Predicate) | Reported Device Performance (Glucose Pilot Blood Glucose Monitoring System) |
|---|---|
| Measurement Range | 20-600 mg/dL (1.1 to 33.3 mmol/L) |
| (Predicate Range) | (20 - 600 mg/dL, 1.1 to 33.3 mmol/L) |
| Test Time | 5 seconds |
| (Predicate Test Time) | (5 seconds) |
| Sample Volume | Minimum of 1 micro liter |
| (Predicate Sample Volume) | (Minimum of 1 micro liter) |
| Hematocrit Range | 30 - 55% |
| (Predicate Hematocrit Range) | (30 - 55%) |
| Operating Temperature Range | 10°-40°C (50°-104°F) |
| (Predicate Operating Temperature Range) | (6°-44°C, 43°-111°F) |
| Operating Humidity Range | 25-90% Relative Humidity |
| (Predicate Operating Humidity Range) | (10 – 90% Relative Humidity) |
| Memory Capabilities | Stores 350 of the most recent blood test results. |
| (Predicate Memory Capabilities) | (150 blood glucose and control solution tests) |
| Battery Life | Approximately 1000 glucose tests. |
| (Predicate Battery Life) | (1000 tests) |
Study Details
The document mentions "The information provided in this pre-market notification demonstrates that Glucose Plot [Pilot] Monitoring System is substantially equivalent to Ultra One Touch Blood Glucose Monitoring System. Substantial Equivalence was established through comparison of intended use and physical properties to the commercialized predicate devices. The information supplied in this pro-marketing notification provides reasonable assurance that the Glucose Pilot Blood Glucose Monitoring System is safe and effective for its stated intended use."
This indicates that the "study" demonstrating equivalence primarily involved analytical and performance testing to show the new device meets the same specifications and analytical performance characteristics as the predicate device. Details of a formal "clinical study" in the sense of a large-scale patient trial with statistical comparison of diagnostic accuracy against a gold standard are not provided in this summary.
2. Sample size used for the test set and the data provenance
- Sample size used for the test set: Not explicitly stated in this 510(k) summary. For glucose meters, accuracy studies typically involve a certain number of subjects across different glucose ranges.
- Data provenance: Not explicitly stated. For a 510(k) submission from a Chinese manufacturer, the testing could be done in China (country of origin for manufacturing) or potentially through contract labs elsewhere. The submission itself is dated from China with a US contact. It's safe to assume it's retrospective analytical performance data.
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 510(k) summary. For blood glucose meters, the "ground truth" for comparative studies is typically established by laboratory reference methods (e.g., YSI analyzer) rather than expert consensus on diagnostic images.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- This information is not applicable/provided as the ground truth for blood glucose measurements is generally established by a laboratory reference instrument, not by human expert adjudication in the context of image interpretation.
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 information is not applicable/provided. The device is a Blood Glucose Monitoring System, which is an in vitro diagnostic device for quantitative measurement, not an AI-powered diagnostic imaging system requiring human reader performance analysis.
6. If a standalone (i.e., algorithm only without human-in-the loop performance) was done
- Yes, implicitly. The "standalone" performance for a blood glucose meter refers to its analytical accuracy and precision in measuring glucose concentrations, independent of human interpretation of a complex output. The specifications (measurement range, test time, sample volume, etc.) are characteristics of the device itself.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For blood glucose monitoring systems, the ground truth is typically established using a laboratory reference method (e.g., a YSI STAT PLUS Glucose & Lactate Analyzer, hexokinase method, or similar highly accurate laboratory method) on plasma or whole blood samples. This document does not explicitly state the specific reference method used, but it would be a standard part of analytical performance testing.
8. The sample size for the training set
- This information is not applicable/provided in the context of this traditional electrochemical biosensor device. Blood glucose meters are not typically "trained" using machine learning algorithms in the same way an AI-driven image analysis system would be. Their performance is based on the chemical and electrochemical properties of the test strips and the meter's calibration algorithms.
9. How the ground truth for the training set was established
- This information is not applicable/provided for the reasons stated in point 8.
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SECTION II 510(k) SUMMARY
This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
51O{k) Number: Designed K#: 052208
Submitter:
Tianjin New Bay Bioresearch Co., Ltd. #3 Jian She Rd, Ba Li Tai Industry Area Jin Nan District, Tianiin, China Telephone: 86-22-28751515 Facsimile: 86-222-875-1516
Contact Person:
Rodrigo Berlie New Product Development Director Telephone: (760) 602-2929 Facsimile: (760) 602-2999
Preparation Date:
Nov. 10. 2005 Device Information:
Device Classification Name: Quantitative of Blood glucose by using Electrochemical biosensor. Common/Usual Name: Blood Glucose Monitoring System. Proprietary Name: Glucose Pilot Glucose Monitoring System. Regulation Number: 21 CFR§862.1345, Glucose test system. 21 CFR§862.1660, Quantity Control Material Regulatory Name: Glucose Test System Product Code: NBW, CGA, JJX Regulatory Class: Class II
Predicate Devices:
Glucose Pilot Glucose Monitoring System is substantially equivalent to Ultra One Touch Glucose monitoring system of Life Scan. Cleared by FDA (K024194).
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Device Description:
The Glucose Pilot Glucose monitoring System consists of a hand-held blood glucose The Gracose Prior States, Lance device, storage case, and two levels of control meter, tost surps, innetter, Earins has a lot - specific calibration information and the meter reads automatically.
The meter is turned on by inserting the strip, the user supplies the capillary blood or The meter is turned on of morning meter makes an audible tone and starts the assay, which completes in five seconds. The meter's software converts the results read off the writen continers a plasma glucose concentration and displays the value on the meter's test surp into a plasma gavoss provided instructions and illustrations explaining that the blood drop will be pulled into the strip sample entry by capillary action. Results are stored in the meter's memory for tracking purposes.
Intended Use:
The Glucose Pilot Blood Glucose Monitoring system is intended for in vitro diagnostic use. The system is intended to be used for the quantitative measurement of capillary ase. The oysterials in intended for use by healthcare professionals and people with diabetes mellitus at home as an aid in monitoring the effectiveness of a diabetes control morram. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.
Comparison to Predicate Device(s):
Glucose Pilot Glucose Monitoring System is substantially equivalent to cleared by FDA, e.g., Ultra One Touch Glucose Monitoring System (024194).
| CHARACTERISTICS | NEW DEVICE:Glucose Pilot BLOOD GLUCOSEMONITORING SYSTEM | PREDICATE:ONETOUCH™ ULTRAGLUCOSE MONITORINGSYSTEM |
|---|---|---|
| Premarket Notification | K052208 | K024194 |
| Manufacturer | New Bay Bioresearch, Co. Ltd. | LifeScan, Inc (U.S.A.) |
| Type of Meter | Biosensor (Electrode) | Biosensor (Electrode) |
| Glucose Measurement Technology(Test Strip) | Glucose pilot Test Strip | ONETOUCH™ Ultra Test Strip |
| Intended Use | To quantitatively measure glucosein fresh capillary whole blood. | To quantitatively measureglucose in fresh capillary wholeblood. |
| Sample Source | Capillary whole blood | Capillary whole blood |
| Sample Application | Blood sample is placed directly tothe test strip after finger is lanced. | Blood sample is placed directlyto the test strip after finger islanced. |
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| lanced. | ||
|---|---|---|
| Hematocrit Range | 30 - 55% | 30 - 55% |
| Control Solution(s) | Glucose pilot Control Solution | ONETOUCH™ Ultra Control Solution |
| Operating Temperature Range | 10°-40°C (50°-104°F) | 6°-44°C(43°-111°F) |
| Operating Humidity Range | 25-90% Relative Humidity | 10 – 90% Relative Humidity |
| Dimensions | 3.2" (L) x 2.3" (W) x 0.8"(H) | 3.12" x 2.25" x 0.85" |
| Weight | 2.5 ounces (72g) including 2 batteries | 1.5 ounces(43g) with battery |
| Display | Liquid Crystal Display (LCD) | Liquid Crystal Display (LCD) |
| Results Presentation | mg/dL or mmol/L | mg/dL or mmol/L |
| Memory Capabilities | Stores 350 of the most recent blood test results. Results of the test solution are not stored in the memory. | 150 blood glucose and control solution tests |
| Test Start | Automatic | Automatic |
| Test Time | 5 seconds | 5 seconds |
| Power Source | Two replaceable AAA size batteries | One replaceable 3.0v lithium battery |
| Battery Life | Approximately 1000 glucose tests. | 1000 tests |
| Measurement Range | 20-600 mg/dL (1.1 to 33.3 mmol/L. Lower results are displayed as “LO”. Higher results are displayed as “HI”. | 20 - 600 mg/dL (1.1 to 33.3 mmol/L |
| Qualified Test Strip | Glucose pilot Test Strip | ONETOUCH™Ultra Test Strip |
| Sample Volume | Minimum of 1 micro liter | Minimum of 1 micro liter |
Summary:
The information provided in this pre-market notification demonstrates that Clucose Plot I he information provided in and per mixalent to Ultra One Touch Blood Glucose Monitoring Montoning System is succembary of equipment ated through comparison of intended use and System Substantial Cquiration was lable and analytical predicate devices. The pliysical proportios to the commerceded notification provides reasonable assurance that the Information supplied in this pro marketing safe and effective for its stated intended use.
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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus, which is a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus. The logo is black and white.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
2005
DEC 9
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Tianjin New Bay Bioresearch Co., Ltd. c/o Mr. Rodrigo Berlie New Product Development Director Aviara Biotech, LLC 3108 Avenida Olmeda Carlsbad, CA 92009
K052208 Re:
R052200
Trade/Device Name: Glucose Pilot Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: NBW, CGA, JJX, Dated: October 27, 2005 Received: November 9, 2005
Dear Mr. Berlie,
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave leviewed your booton stock process is substantially equivalent (for the indications for relered above and nave decemined the esse predicate devices marketed in interstate commerce use stated in the encreative to regary manolitics of the Medical Device Amendments, or to devices that provision with 20, 1770, the onactions associations of the Federal Food, Drug, and Cosmetic have bech recalssinod in accordance wif a premarket approval application (PMA). You may, Act (Act) that ao not require apple to the general controls provisions of the Act. The general therefore, mailion the do roo, one joide requirements for annual registration, listing of devices, good Controls provisions or also and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device to such additional controls. Existing major regulations affecting your device can be may of subject to sublications: consistent (CFR), Parts 800 to 895. In addition, FDA may round in further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean r lease be advised that 1 Dr. 3 team. to t your device complies with other requirements of the Act or that FDA nas made a decemination administered by other Federal agencies. You must comply with ally rederal statutes and regarante abut not limited to: registration and listing (21 CFR Part 807); an the Act 3 requirements, melaining 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) I his letter will anow you to begin marketing your over of your device to a legally premarket notification. "The PDT Intently of 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, If you desire specific information advertising of your device, please contact the Office of In of questions on the promotion and Safety at (240) 276-0484. Also, please note the Vitto Daglosito Dorios Lranian by reference to premarket notification" (21CFR Part 807.97). I guilanon chitica, "Misolunding of responsibilities under the Act from the I ou may other 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 G
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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INDICATIONS FOR USE STATEMENT
0 510(k) Number: K05228
Glucose Pilot Blood Glucose Monitoring System Device name:
Indications for Use:
The Glucose Pilot Blood Glucose monitoring System is intended for the quantitative The Classes in fresh capillary whole blood from a finger stick, for the lay-user. It is also intended for the professional use, which include fresh capillary ia) assn and It is intended for use outside the body (in vitro diagnostic use) by whole blood. It is in the control.
Prescription Use __ (Part 21 CFR 801 Subpart D)
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________ AND/OR (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)
Carol C. Benson
Division Sign-Off
Page 1 of 1
. Office of In Vitro Diagnostic Device Evaluation and Safety 510(k): K052208
§ 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.