(8 days)
The BioScanner Plus Glucose Test Systems are intended for the quantitative determination of glucose in human whole blood for use by healthcare professionals in both physicians' offices and in acute and convalescent care facility bedside testing and individuals at home. 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.
The BioScanner Plus, as modified, is an in vitro diagnostic device consisting of both a reflectance photometer and an amperometer. This device measures various analytes in blood once the blood is applied to dry phase test strips that are specifically designed for reflectance or amperometric analysis. The test strips have not been modified. The unmodified BioScanner Plus contains a reflectance photometer. The modified BioScanner Plus has an additional amperometric circuit.
The provided 510(k) summary for the BioScanner Plus device does not contain the detailed information necessary to fully address all aspects of your request regarding acceptance criteria and the study proving the device meets those criteria. Specifically, the summary focuses on demonstrating substantial equivalence to predicate devices and describes the device's modification and intended use, rather than presenting a performance study with specific acceptance criteria and results.
However, based on the information provided, here's what can be extracted and inferred:
1. Table of Acceptance Criteria and Reported Device Performance
The 510(k) summary does not explicitly state quantitative acceptance criteria or report specific performance metrics (e.g., accuracy, precision) that would typically be associated with a device performance study. The submission primarily focuses on the device's design, intended use, and its similarities to legally marketed predicate devices to establish substantial equivalence.
2. Sample Size Used for the Test Set and Data Provenance
The 510(k) summary does not provide any information regarding the sample size used for a test set or the provenance of any data. This type of detail is typically found in a separate performance study section, which is not included in this summary.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
There is no mention of a ground truth establishment process, experts, or their qualifications in this 510(k) summary. This information would be relevant if a clinical or analytical performance study was detailed.
4. Adjudication Method for the Test Set
No information is provided about an adjudication method, as no specific test set or study methodology is described.
5. If a multi-reader, multi-case (MRMC) comparative effectiveness study was done
No information is provided about a multi-reader multi-case (MRMC) comparative effectiveness study. This type of study is more common for imaging or diagnostic devices where human interpretation plays a significant role. For a glucose meter, the focus is typically on the device's analytical accuracy.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The BioScanner Plus is a quantitative glucose measurement device. Its performance is inherently "standalone" in terms of its ability to measure glucose from a biological sample. A "human-in-the-loop" performance study in the context of interpretation (like with imaging) is not applicable here. The accuracy of the device itself would be evaluated. However, the summary does not detail such an evaluation.
7. The Type of Ground Truth Used
The summary does not explicitly state the type of ground truth used. For a glucose meter, the ground truth for an analytical performance study would typically be a reference laboratory method for glucose measurement (e.g., hexokinase method, YSI analyzer) known for its high accuracy and precision.
8. The Sample Size for the Training Set
There is no mention of a "training set" in the context of this 510(k) summary. This term is most often used in the development of machine learning or AI algorithms. The BioScanner Plus is described as a reflectance photometer and an amperometer, implying a more traditional analytical device with established chemical and optical principles, not one that relies on a machine learning model requiring a separate training set.
9. How the Ground Truth for the Training Set Was Established
As there is no mention of a training set, there is no information on how its ground truth might have been established.
Summary of Device and 510(k) Submission:
The 510(k) summary describes the BioScanner Plus, an in vitro diagnostic device for quantitative determination of glucose in human whole blood. The submission's primary purpose is to establish substantial equivalence for a modified BioScanner Plus compared to several predicate devices. The modification involves adding an amperometric circuit to the existing reflectance photometer, essentially combining the functionalities of two predicate devices (the BioScanner Plus with reflectance photometry and the BioScanner Beyond Glucose Analyzer with amperometry) into a single new device. The intended use remains the same: for use by healthcare professionals and individuals at home for the diagnosis and treatment of carbohydrate metabolism disorders.
The core of this 510(k) relies on the fact that both the reflectance photometry and amperometry technologies, as well as the test strips, are already cleared through previous 510(k)s (K013173, K972669, K013203). The argument for substantial equivalence is that by combining these already-cleared technologies, the modified device does not raise new questions of safety or effectiveness. Therefore, the submission focuses on comparing the features and technology of the modified device to its predicates, rather than presenting new, detailed performance studies with quantitative acceptance criteria.
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SECTION F: 510(k) Summary
510(k) SUMMARY
This summary of safety and effectiveness information is submitted in compliance with 21CFR807.92.
- Application Date: 1.
DEC 2 1 2001
Applicant Information: 2.
Polymer Technology Systems, Inc. 7736 Zionsville Road Indianapolis, IN 46268
December 7, 2001
Contact Person: Margo Enright Phone Number: 317-870-5610 317-870-5608 FAX Number: E-mail: mme@diabetes-testing.com
Trade Names: 3.
BioScanner Plus BioScanner Glucose Test Strips BioScanner Beyond Glucose Test Strips
Description 4.
The BioScanner Plus, as modified, is an in vitro diagnostic device consisting of both a reflectance photometer and an amperometer. This device measures various analytes in blood once the blood is applied to dry phase test strips that are specifically designed for reflectance or amperometric analysis. The test strips have not been modified.
The unmodified BioScanner Plus contains a reflectance photometer. The modified BioScanner Plus has an additional amperometric circuit.
Classification Names: ನ.
Glucose Test System Panel: Clinical Chemistry 75 Product Codes: CGA, NBW
- Facility Address: 6. 7736 Zionsville Road Indianapolis, IN 46268
- Device Classification: Class II (Regulation: 21 CFR 862.1345) 7.
Intended Use: 8.
The BioScanner Plus Glucose Test Systems are intended for the quantitative determination of glucose in human whole blood for use by healthcare professionals in both physicians' offices and in acute and convalescent care facility bedside testing and individuals at home. 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.
- Reason for 510(k): 9.
Device Modification
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Predicate Device Information 10.
ate Device Innormation
The following table lists the predicate devices for this submission for
determination of substantial equivalence:
| New Device | Predicates | K Numbers |
|---|---|---|
| Modified BioScannerPlus* | BioScanner Plus* | K013173 |
| BioScanner 2000* | K972669 | |
| BioScanner Beyond GlucoseAnalyzer* | K013203 |
*Device Company: Polymer Technology Systems
Similarities and Differences
...
| Items Compared | Similarities | Differences |
|---|---|---|
| 1. Modified BioScanner Plusto BioScanner Plus(K013173) | 1. Both include all the samefeatures and technology(reflectance photometry) torun colorimetric tests. | The modified devicecombines two predicatedevices. It combines theamperometric BioScannerBeyond Glucose Analyzer(K013203) with thereflectance photometer in theBioScanner Plus (K013173)and incorporates them into asingle device. |
| 2. Modified BioScanner Plusto BioScanner BeyondGlucose Analyzer (K013203) | 2. Both include all the samefeatures and technology (torun amperometric tests). | |
| Test strips used withmodified BioScanner Plus | ||
| 3. BioScanner Glucose TestStrips (colorimetric teststrips:K972669) | 3. Same test strip used onmodified BioScannerPlus as on BioScannerPlus and BioScanner. | 3. None. |
| 4. BioScanner BeyondGlucose Test Strips(amperometric test strips,K013203) | 4. Same test strip used onmodified BioScannerPlus as on BioScannerBeyond GlucoseAnalyzer | 4. None. |
| Intended Use: Modifieddevice compared tounmodified | Same intended use. | None |
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized symbol that resembles three human profiles facing right, stacked on top of each other, with flowing lines extending from the bottom profile.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
DEC 2 1 2001
Ms. Margo Enright Manager of Clinical Affairs Polymer Technology Systems, Inc. 7736 Zionsville Road Indianapolis, IN 46268
K014099 Re: Trade/Device Name: BioScanner Plus for Professional and OTC Use Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: NBW Dated: December 7, 2001 Received: December 13, 2001
Dear Ms. Enright:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roviewed your betermined 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 encreate) 70 ttg enactment date of the Medical Device Amendments, or to conninered pror to May 20, 1977 , is accordance with the provisions of the Federal Food, Drug, devices that have occh resuire approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r ou may, diererore, manovate a et include requirements for annual registration, listing of general controls provactice, 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 If your device is elaboried too as controls. Existing major regulations affecting your device can may or subject to about areas 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 that I Drivial statutes and regulations administered by other Federal agencies. You must or any I out 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 el It in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic form in the quarty of crovisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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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/cdrb/dsma/dsmamain.html".
Sincerely yours,
Steven Sutman
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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Page
. of
Center for Devices and Radiological Health
510(k) Number (if known): HO14099
Device Name: BioScanner Plus for Professional and OTC Use
Indications for Use:
The BioScanner Plus Glucose Test Systems are intended for the quantitative determination of glucose in human whole blood for use by healthcare professionals in both physicians' offices and in acute and convalescent care facility bedside testing and individuals at home. 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.
Jean Cooper
(Division Sign-Off)
Division of Clinical Laboratory Lices
510(k) Number K014099
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-CounterUse
(Optional Format 1-2-96)
§ 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.