The Rightest Blood Glucose Monitoring System GM700 is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm. The Rightest Blood Glucose Monitoring System GM700 is intended to be used by a single person and should not be shared.

The Rightest Blood Glucose Monitoring System GM700 is intended for self testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The Rightest Blood Glucose Monitoring System GM700 should not be used for the diagnosis of, or screening for diabetes or for neonatal use. Alternative site testing should be done only during steady - state times (when glucose is not changing rapidly).

The Rightest Blood Glucose Test Strips GS700 are for use with the Rightest Blood Glucose Meter GM700 to quantitatively measure alucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm,

The GE200 Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm. The GE200 Blood Glucose Monitoring System is intended to be used by a single person and should not be shared.

The GE200 Blood Glucose Monitoring System is intended for self testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The GE200 Blood Glucose Monitoring System should not be used for the diagnosis of, or screening for diabetes or for neonatal use. Alternative site testing should be done only during steady - state times (when glucose is not changing rapidly).

The GE200 Blood Glucose Test Strips are for use with the GE200 Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm.

The Rightest Blood Glucose Monitoring System GM650 is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm. The Rightest Blood Glucose Monitoring System GM650 is intended to be used by a single person and should not be shared.

The Rightest Blood Glucose Monitoring System GM650 is intended for self testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The Rightest Blood Glucose Monitoring System GM650 should not be used for the diagnosis of, or screening for diabetes or for neonatal use. Alternative site testing should be done only during steady - state times (when glucose is not changing rapidly).

The Rightest Blood Glucose Test Strips GS650 are for use with the Rightest Blood Glucose Meter GM650 to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm.

The GE300 Talking Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm. The GE300 Talking Blood Glucose Monitoring System is intended to be used by a single person and should not be shared.

The GE300 Talking Blood Glucose Monitoring System is intended for self testing outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The GE300 Talking Blood Glucose Monitoring System should not be used for the diagnosis of, or screening for diabetes or for neonatal use. Alternative site testing should be done only during steady - state times (when glucose is not changing rapidly).

The GE300 Talking Blood Glucose Test Strips are for use with the GE300 Talking Blood Glucose Meter to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm.

Device Description

Our Rightest Blood Glucose Monitoring System GM700 consists of the following devices: Rightest Blood Glucose Meter GM700, Rightest Blood Glucose Test Strip GS700, Rightest Control Solution GC700, lancing device and sterile lancets. The Rightest Blood Glucose Meter GM700, Rightest Blood Glucose Test Strips GS700, and Lancing Device are manufactured by BIONIME Corporation. The Rightest Blood Glucose Meter GM700, when used with the Rightest Blood Glucose Test Strips GS700, quantitatively measures glucose in fresh capillary whole blood. The performance of the Rightest Blood Glucose Monitoring System GM700 is verified by the Rightest Control Solution GC700.

Our GE200 Blood Glucose Monitoring System consists of the following devices: GE200 Blood Glucose Meter, GE200 Blood Glucose Test Strip, GE200 Control Solution, lancing device and sterile lancets. The GE200 Blood Glucose Meter, GE200 Blood Glucose Test Strips, and Lancing Device are manufactured by BIONIME Corporation. The GE200 Blood Glucose Meter, when used with the GE200 Blood Glucose Test Strips, quantitatively measures glucose in fresh capillary whole blood. The performance of the GE200 Blood Glucose Monitoring System is verified by the GE200 Control Solution.

Our Rightest Blood Glucose Monitoring System GM650 consists of the following devices: Rightest Blood Glucose Meter GM650, Rightest Blood Glucose Test Strip GS650, Rightest Control Solution GC650, lancing device and sterile lancets. The Rightest Blood Glucose Meter GM650. Rightest Blood Glucose Test Strips GS650, and Lancing Device are manufactured by BIONIME Corporation. The Rightest Blood Glucose Meter GM650, when used with the Rightest Blood Glucose Test Strips GS650, quantitatively measures glucose in fresh capillary whole blood. The performance of the Rightest Blood Glucose Monitoring System GM650 is verified by the Rightest Control Solution GC650.

Our GE300 Talking Blood Glucose Monitoring System consists of the following devices: GE300 Talking Blood Glucose Meter, GE300 Talking Blood Glucose Test Strip, GE300 Series Control Solution, lancing device and sterile lancets. The GE300 Talking Blood Glucose Meter. GE300 Talking Blood Glucose Test Strips, and Lancing Device are manufactured by BIONIME Corporation. The GE300 Talking Blood Glucose Meter, when used with the GE300 Talking Blood Glucose Test Strips, quantitatively measures glucose in fresh capillary whole blood. The performance of the GE300 Talking Blood Glucose Monitoring System is verified by the GE300 Series Control Solution.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the BIONIME Blood Glucose Monitoring Systems, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state acceptance criteria in a numerical or percentage format for accuracy or other performance metrics. Instead, it relies on demonstrating "substantial equivalence" to predicate devices through various tests.

The comparison tables (Exhibit #1, pages 4-5) primarily focus on the specifications of the new devices (GM700, GE200, GM650, GE300) against their respective predicate devices (K110737, K120423). These specifications represent the design parameters and functional characteristics rather than direct acceptance criteria for clinical accuracy.

However, the "Discussion of Non-Clinical Tests Performed" (Exhibit #1, page 6) mentions that the evaluation included:

Precision
Linearity
Interference
Sample volume
Hematocrit

The acceptance criteria for these tests are implied to be met if the results demonstrate substantial equivalence to the predicate devices and support the intended use. Without direct numerical targets for these (e.g., specific CV% for precision, correlation coefficient for linearity), a detailed "reported device performance" against stated acceptance criteria cannot be fully populated from this document.

Implied Acceptance Criteria and Performance (Based on Substantial Equivalence):

Acceptance Criterion (Implied)	Reported Device Performance (Implied by Substantial Equivalence)
Precision	Verified to be substantially equivalent to predicate devices.
Linearity	Verified to be substantially equivalent to predicate devices.
Interference	Performance with noted interferents (Uric acid, Xylose, Ascorbic acid, Dopamine HCI, L-Dopa) verified to be acceptable and comparable or improved, depending on the specific device model vs. predicate.
Sample Volume	Tested at 0.75 microliters (for new devices, different from predicate's 1.0 microliter), indicating acceptable performance at this volume.
Hematocrit Range	Performance verified within 30-55% range.
Measuring Range	20-600 mg/dL (identical to predicate).
Test Time	5 seconds (identical to predicate).
Other Physical/Functional Specs	All other 'similarities' listed in the comparison tables were met.

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

The document does not explicitly state the sample sizes used for the verification and validation tests (precision, linearity, interference, sample volume, hematocrit).

The data provenance (e.g., country of origin, retrospective/prospective) is also not specified.

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

This information is not provided in the document. For blood glucose monitoring systems, ground truth is typically established using a laboratory reference method, not expert consensus in the same way as image analysis.

4. Adjudication Method for the Test Set

This information is not provided. As noted above, ground truth for blood glucose measurements often relies on comparative analysis with a reference method, rather than expert adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study is not mentioned and is generally not applicable to the evaluation of point-of-care blood glucose monitoring systems, which are objective measurement devices rather than diagnostic interpretation tools for human readers.

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

This refers to the performance of the device itself (the meter and test strip) without human interpretative intervention, which is precisely what the non-clinical tests (precision, linearity, interference, etc.) are designed to evaluate. So, yes, standalone performance was assessed through these verification and validation tests. The results of the meter measuring glucose in blood samples are inherently "standalone."

7. The Type of Ground Truth Used

For a blood glucose monitoring system, the ground truth is typically established by laboratory reference methods. While not explicitly stated, the comparison would have been against a highly accurate laboratory glucose analyzer. The document implies this by stating that the devices "quantitatively measures glucose in fresh capillary whole blood" and that performance was evaluated for "precision, linearity, interference, sample volume and hematocrit," which are all usually assessed against a known standard or reference method.

8. The Sample Size for the Training Set

This document describes a 510(k) submission for conventional medical devices (blood glucose meters) which are based on electrochemical sensing technology, not machine learning or AI models that require "training sets." Therefore, the concept of a "training set" in the context of AI/ML is not applicable here.

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

As explained above, the concept of a "training set" is not applicable to this type of device.

Summary

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Exhibit #1

. 510(K) SUMMARY

JAN 2 5 2013

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.

The assigned 510(k) number is: (123008

1. Submitter's Identification:
  BIONIME CORPORRATION NO 694, RENHUA ROAD, DALI DIST., TAICHUNG CITY, TAIWAN 412 Contact Person: Phone Number: 886-4-24951268 FAX Number: 886-4-24952568

Date Summary Prepared: September 24, 2012

1. Name of the Device: Rightest Blood Glucose Monitoring System GM700 GE200 Blood Glucose Monitoring System Rightest Blood Glucose Monitoring System GM650 GE300 Talking Blood Glucose Monitoring System
1. Common or Usual Name: Glucose test system

Product Code	Classification	Regulation Section	Panel
NBW; System, Test, BloodGlucose, Over-the-Counter	Class II	21 CFR 862.1345	Clinical Chemistry75
LFR; GlucoseDehydrogenase, Glucose	Class II	21 CFR 862.1345	Clinical Chemistry75

Device Description: 4.

4.1 Our Rightest Blood Glucose Monitoring System GM700 consists of the following devices: Rightest Blood Glucose Meter GM700, Rightest Blood Glucose Test Strip GS700, Rightest Control Solution GC700, lancing device and sterile lancets. The Rightest Blood Glucose Meter GM700, Rightest Blood Glucose Test Strips GS700, and Lancing Device are manufactured by BIONIME Corporation. The Rightest Blood Glucose Meter GM700, when used with the Rightest Blood Glucose Test Strips GS700, quantitatively measures glucose in fresh capillary whole blood. The performance of the Rightest Blood Glucose Monitoring System GM700 is verified by the Rightest Control Solution GC700.

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4.2 Our GE200 Blood Glucose Monitoring System consists of the following devices: GE200 Blood Glucose Meter, GE200 Blood Glucose Test Strip, GE200 Control Solution, lancing device and sterile lancets. The GE200 Blood Glucose Meter, GE200 Blood Glucose Test Strips, and Lancing Device are manufactured by BIONIME Corporation. The GE200 Blood Glucose Meter, when used with the GE200 Blood Glucose Test Strips, quantitatively measures glucose in fresh capillary whole blood. The performance of the GE200 Blood Glucose Monitoring System is verified by the GE200 Control Solution.

4.3 Our Rightest Blood Glucose Monitoring System GM650 consists of the following devices: Rightest Blood Glucose Meter GM650, Rightest Blood Glucose Test Strip GS650, Rightest Control Solution GC650, lancing device and sterile lancets. The Rightest Blood Glucose Meter GM650. Rightest Blood Glucose Test Strips GS650, and Lancing Device are manufactured by BIONIME Corporation. The Rightest Blood Glucose Meter GM650, when used with the Rightest Blood Glucose Test Strips GS650, quantitatively measures glucose in fresh capillary whole blood. The performance of the Rightest Blood Glucose Monitoring System GM650 is verified by the Rightest Control Solution GC650.

4.4 Our GE300 Talking Blood Glucose Monitoring System consists of the following devices: GE300 Talking Blood Glucose Meter, GE300 Talking Blood Glucose Test Strip, GE300 Series Control Solution, lancing device and sterile lancets. The GE300 Talking Blood Glucose Meter. GE300 Talking Blood Glucose Test Strips, and Lancing Device are manufactured by BIONIME Corporation. The GE300 Talking Blood Glucose Meter, when used with the GE300 Talking Blood Glucose Test Strips, quantitatively measures glucose in fresh capillary whole blood. The performance of the GE300 Talking Blood Glucose Monitoring System is verified by the GE300 Series Control Solution.

5. Intended Use:

5.1 The Rightest Blood Glucose Monitoring System GM700 is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm. The Rightest Blood Glucose Monitoring System GM700 is intended to be used by a single person and should not be shared.

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5.2 The GE200 Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm. The GE200 Blood Glucose Monitoring System is intended to be used by a single person and should not be shared.

5.3 The Rightest Blood Glucose Monitoring System GM650 is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm. The Rightest Blood Glucose Monitoring System GM650 is intended to be used by a single person and should not be shared.

5.4 The GE300 Talking Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm. The GE300 Talking Blood Glucose Monitoring System is intended to be used by a single person and should not be shared.

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6. Predicate Device Information:

The Rightest Blood Glucose Monitoring System GM700 and the GE200 Blood Glucose Monitoring System are substantially equivalent to the brand of Rightest Blood Glucose Monitoring System noted below.

Name: Rightest Blood Glucose Monitoring System GM700 Device Company: Bionime Corporation 510(K) Number: K110737.

The Rightest Blood Glucose Monitoring System GM650 and the GE300 Talking Blood Glucose Monitoring System are substantially equivalent to the brand of Rightest Blood Glucose Monitoring System noted below.

Name: Rightest Blood Glucose Monitoring System GM650 Device Company: Bionime Corporation 510(K) Number: K120423.

7. Comparison to Predicate Devices:

Specification Comparison

Item	New Device	Predicate Device
	GE200	Rightest GM700 (K110737)
	Rightest GM700
	Similarities
Test Time	5 seconds
Measuring Range	20-600 mg/dL

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Hematocrit Range	30 - 55%
Operating Relative HumidityRange	10 ~ 90%
Operating Temperature Range	43~~111 °F (6~~44°C )
Battery Life	About 1000 tests
Monitor	LCD display
Memory Capacity	1000 blood glucose test results with date and time
Coding	Auto coding
Meter Storage Conditions	14~140 °F (-10 ~ 60°C )
Test Strip Storage Conditions	39~86 °F (4 ~ 30°C), <90% relative humidity
The unit of measurement data	Fix on mg/dL
Sample	Capillary whole blood
Measurement Technology	Dehydrogenase Electrochemical Sensor
	Differences
Minimum Sample Volume	0.75 microliter	1.0 microliter
Interference	Uric acid ≥ 16 mg/dLXylose ≥ 10 mg/dLAscorbic acid ≥ 3 mg/dLDopamine HCI ≥ 1.25 mg/dLL-Dopa ≥ 2 mg/dL	Uric acid ≥ 10 mg/dLXylose ≥ 10 mg/dL
	Strip Reagent	1.FAD-glucose Dehydrogenase(FAD-GDH) 12.1%2.Potassium ferricyanide 48.5%3.Non-reactive ingredients39.4%	1.FAD-glucose Dehydrogenase(FAD-GDH) 9.0%2.Potassium ferricyanide 53.7%3.Non-reactive ingredients37.3%
		Power Supply	Two CR2032batteries	One CR2032 batteries
		Meter Dimension	96mm46mm17.5mm	98 mm × 46 mm × 17.5 mm
	Meter Weight	65.0 ± 5 g withbatteries	57.0 ± 5 g with batteries
Backlight	Yes	No
Control solution	Level 1, 2 and 4	L1, L2, L3, L4, L5

{5}------------------------------------------------

Specification Comparison

Item	New Device	Predicate Device
	Rightest GM650 /GE300 Talking	Rightest GM650 (K120423)
	Similarities
Minimum Sample Volume	0.75 microliter
Test Time	5 seconds
Measuring Range	20-600 mg/dL
Hematocrit Range	30 - 55%
Operating Relative HumidityRange	10 ~ 90%
Operating Temperature Range	43 ~ 111 °F (6 ~ 44°C )
Battery Life	About 1000 tests
Monitor	LCD display
Memory Capacity	500 blood glucose test results with date and time
Coding	Auto coding
Meter Storage Conditions	14 ~ 140 °F (-10 ~ 60°C )
Test Strip Storage Conditions	39 ~ 86 °F (4 ~ 30°C ), <90% relative humidity
The unit of measurement data	Fix on mg/dL
Sample	Capillary whole blood
Measurement Technology	Dehydrogenase Electrochemical Sensor
Power Supply	Two 1.5V (AAA) batteries
Meter Dimension	50 mm × 18 mm × 105 mm
Meter Weight	80.0 ± 5 g with batteries
LCD display area	48 mm × 34 mm
Backlight	No
Control solution	Level 1, 2 and 4
Voice Function	Yes
Data Transmission	Infrared
Stereo jack	Yes
Voice repeat button	Yes
	Differences
Interference	Uric acid ≥ 16 mg/dLXylose ≥ 10 mg/dLAscorbic acid ≥ 3 mg/dLDopamine HCI ≥ 1.25 mg/dLL-Dopa ≥ 2 mg/dL	Uric acid ≥ 10 mg/dLXylose ≥ 10 mg/dL
Strip Reagent	1.FAD-glucose Dehydrogenase(FAD-GDH) 12.1%2.Potassium ferricyanide 48.5%3.Non-reactive ingredients39.4%	1.FAD-glucose Dehydrogenase(FAD-GDH) 9.0%2.Potassium ferricyanide 53.7%3.Non-reactive ingredients37.3%

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8. Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence are as follows:

Verification and validation of test results were evaluated to establish the performance, functionality and reliability of the Rightest Blood Glucose Monitoring System GM700, the GE200 Blood Glucose Monitoring System, the Rightest Blood Glucose Monitoring System GM650, and the GE300 Talking Blood Glucose Monitoring System. The evaluation included precision, linearity, interference, sample volume and hematocrit.

9. Conclusions:

Results of performance evaluation of the Rightest Blood Glucose Monitoring System GM700, the GE200 Blood Glucose Monitoring System, the Rightest Blood Glucose Monitoring System GM650, and the GE300 Talking Blood Glucose Monitoring System demonstrate that the devise is substantial equivalence to the predicate

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device, Rightest Blood Glucose Monitoring System GM700 and Rightest Blood Glucose Monitoring System GM650.

. . . . . . .

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Image /page/8/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in all caps and is black. The text is centered in the image.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

January 25, 2013

Bionime Corporation c/o MDI Consultant, Inc. Jigar Shah 55 Northern Blvd, Suite 200 Great Neck, NY 11021

Re: K123008

Trade/Device Name: Rightest Blood Glucose Monitoring System GM700,

GE200 Blood Glucose Monitoring System

Rightest Blood Glucose Monitoring System GM650 GE300 Talking Blood Glucose Monitoring System

Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: II Product Code: NBW, LFR Dated: December 27, 2012 Received: December 28, 2012

Dear Mr. Shah: .

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal 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 or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2— Mr. Shah

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Carol C. Benson

Courtney H. Lias, Ph.D.

Director

Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics

and Radiological Health

Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K123008

Device Name: Rightest Blood Glucose Monitoring System GM700

Indications For Use:

The Rightest Blood Glucose Monitoring System GM700 is intended for self testing i outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The Rightest Blood Glucose Monitoring System GM700 should not be used for the diagnosis of, or screening for diabetes or for neonatal use. Alternative site testing should be done only during steady - state times (when glucose is not changing rapidly).

The Rightest Blood Glucose Test Strips GS700 are for use with the Rightest Blood Glucose Meter GM700 to quantitatively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm.

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

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 In Vitro Diagnostics and Radiological Health (OlR)

Katherine Serrano

Division Sign-Off Office of In Vitro Diagnostics and Radiological Health

510(k) K123008

Page 1 of 4

{11}------------------------------------------------

510(k) Number (if known):K123008

Device Name: GE200 Blood Glucose Monitoring System

Indications For Use:

The GE200 Blood Glucose Test Strips are for use with the GE200 Blood Glucose drewn from the fively measure glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm.

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

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 In Vitro Diagnostics and Radiological Health (OlR)

Katherine Serrano

Division Sign-Off Office of In Vitro Diagnostics and Radiological Health

510(k) K123008

ﯩﯔ

Page 2 of 4

{12}------------------------------------------------

Indications for Use

510(k) Number (if known):K123008

Device Name: Rightest Blood Glucose Monitoring System GM650

Indications For Use:

The Rightest Blood Glucose Monitoring System GM650 is intended for self testing i outside the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The Rightest Blood Glucose Monitoring System GM650 should not be used for the Rightest Dious Should Gillioning for diabetes or for neonatal use. Alternative site testing should be done only during steady - state times (when glucose is not changing rapidly).

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

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 In Vitro Diagnostics and Radiological Health (OIR)

Katherine Serrano

Division Sign-Off Office of In Vitro Diagnostics and Radiological Health

510(k) K123008

Page 3 of 4

{13}------------------------------------------------

Indications for Use

510(k) Number (if known):K123008

Device Name: GE300 Talking Blood Glucose Monitoring System

Indications For Use:

The GE300 Talking Blood Glucose Monitoring System is intended to be used for the quantitative measurement of glucose (sugar) in fresh capillary whole blood samples drawn from the fingertips, forearm or palm. The GE300 Talking Blood Santa Monitoring System is intended to be used by a single person and should not be shared.

The GE300 Talking Blood Glucose Monitoring System is intended for self testing outside i the body (in vitro diagnostic use) by people with diabetes at home as an aid to monitor the effectiveness of diabetes control. The GE300 Talking Blood Glucose Monitoring System should not be used for the diagnosis of, or screening for diabetes or for neonatal use. Alternative site testing should be done only during steady - state times (when glucose is not changing rapidly).

The GE300 Talking Blood Glucose Test Strips are for use with the GE300 Talking Blood Glucose Meter to quantities for Strips are of use with the GESU Taking Blood samples drawn from the fingertips, forearm or palm

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

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 In Vitro Diagnostics and Radiological Health (OIR)

Katherine Serrano

Division Sign-Off Office of In Vitro Diagnostics and Radiological Health

510(k) K123008

Page 4 of 4

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.