(8 days)
Not Found
No
The document describes a standard glucose meter using reflectance photometry and amperometry, with no mention of AI or ML in the intended use, device description, or specific sections for AI/ML mentions.
No.
The device is used for the quantitative determination of glucose in human whole blood, which is a diagnostic purpose, not a therapeutic one. It helps in the diagnosis and treatment of carbohydrate metabolism disorders, but it does not directly treat the condition.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states, "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." This indicates the device is used for diagnostic purposes.
No
The device description explicitly states it consists of both a reflectance photometer and an amperometer, which are hardware components.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states "for the quantitative determination of glucose in human whole blood". This is a classic example of an in vitro diagnostic test, as it analyzes a biological sample (whole blood) outside of the body to diagnose or monitor a medical condition (carbohydrate metabolism disorders).
- Device Description: The device description states "The BioScanner Plus, as modified, is an in vitro diagnostic device". This directly identifies the device as an IVD.
- Mechanism: The device uses dry phase test strips and either reflectance photometry or amperometry to measure analytes in blood. These are common techniques used in in vitro diagnostic testing.
N/A
Intended 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.
Product codes (comma separated list FDA assigned to the subject device)
CGA, NBW
Device Description
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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
healthcare professionals in both physicians' offices and in acute and convalescent care facility bedside testing and individuals at home.
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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.
0
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
1
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 BioScanner | ||
| Plus* | BioScanner Plus* | K013173 |
| BioScanner 2000* | K972669 | |
| BioScanner Beyond Glucose | ||
| Analyzer* | K013203 |
*Device Company: Polymer Technology Systems
Similarities and Differences
...
| Items Compared | Similarities | Differences |
|---|---|---|
| 1. Modified BioScanner Plus | ||
| to BioScanner Plus | ||
| (K013173) | 1. Both include all the same | |
| features and technology | ||
| (reflectance photometry) to | ||
| run colorimetric tests. | The modified device | |
| combines two predicate | ||
| devices. It combines the | ||
| amperometric BioScanner | ||
| Beyond Glucose Analyzer | ||
| (K013203) with the | ||
| reflectance photometer in the | ||
| BioScanner Plus (K013173) | ||
| and incorporates them into a | ||
| single device. | ||
| 2. Modified BioScanner Plus | ||
| to BioScanner Beyond | ||
| Glucose Analyzer (K013203) | 2. Both include all the same | |
| features and technology (to | ||
| run amperometric tests). | ||
| Test strips used with | ||
| modified BioScanner Plus | ||
| 3. BioScanner Glucose Test | ||
| Strips (colorimetric test | ||
| strips:K972669) | 3. Same test strip used on | |
| modified BioScanner | ||
| Plus as on BioScanner | ||
| Plus and BioScanner. | 3. None. | |
| 4. BioScanner Beyond | ||
| Glucose Test Strips | ||
| (amperometric test strips, | ||
| K013203) | 4. Same test strip used on | |
| modified BioScanner | ||
| Plus as on BioScanner | ||
| Beyond Glucose | ||
| Analyzer | 4. None. | |
| Intended Use: Modified | ||
| device compared to | ||
| unmodified | Same intended use. | None |
2
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.
3
Page 2 -
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
4
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)