AP-1010 AND AP-1020 BLOOD GLUCOSE MONITORING SYSTEM, MAJOR GLUCOSE CONTROL SOLUTION

K103044 · Bestgen Biotech Corp. · NBW · Feb 10, 2012 · Clinical Chemistry

Device Facts

• Record ID: K103044
• Device Name: AP-1010 AND AP-1020 BLOOD GLUCOSE MONITORING SYSTEM, MAJOR GLUCOSE CONTROL SOLUTION
• Applicant: Bestgen Biotech Corp.
• Product Code: NBW · Clinical Chemistry
• Decision Date: Feb 10, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The AP - 1010 Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger. The AP - 1010 Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. The AP - 1010 Blood Glucose Monitoring System is intended for self testing outside the body (in vitro diagnostic use) by people with diabetes at home as aid to monitor the effectiveness of diabetes control. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates. The AP - 1010 Blood Glucose Test Strips are intended for the quantitative measurement of glucose in fresh capillary whole blood sample drawn from the fingertips. AP - 1010 Blood Glucose Test Strips must be used with the AP - 1010 Blood Glucose Meter. Testing is done outside the body (In Vitro diagnostic use). It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates. The AP - 1010multi Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger. The AP - 1010multi Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use) and is intended for multi - patient use in professional healthcare settings as an aid to monitor the effectiveness of diabetes control program. This system should only be used with single - use lancing devices. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates. The AP - 1010multi Blood Glucose Test Strips are intended for the quantitative measurement of glucose in fresh capillary whole blood sample drawn from the fingertips. AP - 1010multi Blood Glucose Test Strips must be used with the AP - 1010multi Blood Glucose Meter. Testing is done outside the body (In Vitro diagnostic use). This system should only be used with single - use lancing devices. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates. The AP - 1020 Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger. The AP - 1020 Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. The AP - 1020 Blood Glucose Monitoring Systems is intended for self testing outside the body (in vitro diagnostic use) by people with diabetes at home as aid to monitor the effectiveness of diabetes control. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates. The AP - 1020 Blood Glucose Test Strips are intended for the quantitative measurement of glucose in fresh capillary whole blood sample drawn from the fingertips. AP - 1020 Blood Glucose Test Strips must be used with the AP - 1020 Blood Glucose Meter. Testing is done outside the body (In Vitro diagnostic use). It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates. The AP - 1020multi Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger. The AP - 1020multi Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use) and is intended for multi - patient use in professional healthcare settings as an aid to monitor the effectiveness of diabetes control program. This system should only be used with single - use lancing devices. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates. The AP - 1020multi Blood Glucose Test Strips are intended for the quantitative measurement of glucose in fresh capillary whole blood sample drawn from the fingertips. AP - 1020multi Blood Glucose Test Strips must be used with the AP - 1020multi Blood Glucose Meter. Testing is done outside the body (In Vitro diagnostic use). This system is only used with single - use lancing devices. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.

Device Story

System measures capillary whole blood glucose via electrochemical amperometric method; uses dry reagent biosensor test strips containing glucose oxidase (Aspergillus niger). Input: 0.6–1.0 uL blood sample applied to strip. Meter detects current proportional to glucose concentration; converts signal to quantitative readout. Used in home (single-patient) or professional healthcare settings (multi-patient). Multi-patient versions require single-use, auto-disabling lancing devices and validated disinfection protocols (Caviwipes). Provides glucose concentration (20-600 mg/dL) to aid diabetes management. No data transmission capabilities. User interface includes function buttons and memory for 960 measurements.

Clinical Evidence

No clinical data required. Substantial equivalence supported by bench testing and performance characteristics established in k090389. Disinfection validation performed for multi-patient use models using Caviwipes over 18,250 cycles to simulate 5-year use.

Technological Characteristics

Electrochemical biosensor; glucose oxidase enzyme; meter-based system; capillary blood input; standalone operation.

Indications for Use

Indicated for quantitative measurement of glucose in fresh capillary whole blood from fingertips to monitor diabetes control effectiveness. Intended for single-patient home use or multi-patient professional healthcare settings. Contraindicated for neonates, critically ill patients, patients in shock, dehydrated, hypotensive, or hyperosmolar patients.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• AP-1000 Blood Glucose Monitoring System (k090389)

Submission Summary (Full Text)

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

# 510(k) Summary

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

The Assigned 510(k) number is k103044

# 1. Submitter's Identification

Bestgen Biotech Corporation 7F., No.186, Jian-Yi Rd., 235, Jung-He City, Taipei, Taiwan

Correspondence: Steven Shen Q.A./ Regulatory Manager Tel: [phone] Ext 211 Fax: [phone] E-mail: [e-mail]

### 2. Device Name

Proprietary name: AP-1010, AP-1010multi, AP-1020, and AP-1020multi Blood Glucose Monitoring System

Regulatory information:

| A. Regulation section: | 21 CFR Section 862.1345 Glucose Test System<br>21 CFR Section 862.1660, Quality Control Material |
|------------------------|--------------------------------------------------------------------------------------------------|
| B. Classification: | Class II for 862.1345<br>Class I for 862.1660 |
| C. Product Code: | CGA, Glucose Oxidase, Glucose<br>NBW, System, Test, Blood Glucose, Over The Counter |
| D. Panel: | Chemistry (75) |

#### 3. Intended Use

AP-1010 Blood Glucose Monitoring System

The AP-1010 Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger. The AP-1010 Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. The AP-1010 Blood Glucose Monitoring System is intended for self testing outside the body (in vitro diagnostic use) by people with diabetes at home as aid to monitor the effectiveness of diabetes control. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.

The AP-1010 Blood Glucose Test Strips are intended for the quantitative measurement of glucose in fresh

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

capillary whole blood sample drawn from the fingertips. AP-1010 Blood Glucose Test Strips must be used with the AP-1010 Blood Glucose Meter. Testing is done outside the body (In Vitro diagnostic use). It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.

#### AP-1010multi Blood Glucose Monitoring System

The AP-1010multi Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger. The AP-1010multi Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use) and is intended for multi-patient use in professional healthcare settings as an aid to monitor the effectiveness of diabetes control program. This system should only be used with single-use lancing devices. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.

The AP-1010multi Blood Glucose Test Strips are intended for the quantitative measurement of glucose in fresh capillary whole blood sample drawn from the fingertips. AP-1010multi Blood Glucose Test Strips must be used with the AP-1010multi Blood Glucose Meter. Testing is done outside the body (In Vitro diagnostic use). This system should only be used with single-use lancing devices. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.

#### AP-1020 Blood Glucose Monitoring System

The AP-1020 Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger. The AP-1020 Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. The AP-1020 Blood Glucose Monitoring Systems is intended for self testing outside the body (in vitro diagnostic use) by people with diabetes at home as aid to monitor the effectiveness of diabetes control. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.

The AP-1020 Blood Glucose Test Strips are intended for the quantitative measurement of glucose in fresh capillary whole blood sample drawn from the fingertips. AP-1020 Blood Glucose Test Strips must be used with the AP-1020 Blood Glucose Meter. Testing is done outside the body (In Vitro diagnostic use). It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.

#### AP-1020multi Blood Glucose Monitoring System

The AP-1020multi Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger. The AP-1020multi Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use) and is intended for multi-patient use in professional healthcare settings as an aid to monitor the effectiveness of diabetes control program. This system should only be used with single-use lancing devices. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.

The AP-1020multi Blood Glucose Test Strips are intended for the quantitative measurement of glucose in fresh capillary whole blood sample drawn from the fingertips. AP-1020multi Blood Glucose Test Strips must be used with the AP-1020multi Blood Glucose Meter. Testing is done outside the body (In Vitro diagnostic use). This system is only used with single-use lancing devices. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.

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

#### 4. Device Description

The AP-1010 Blood Glucose Monitoring System consists of three main products: the meter, test strip, and control solutions. These products have been designed, tested, and proven to work together as a system accurate blood glucose test results. Use only AP-1010 test strips and MAJOR control solution with the AP-1010 Blood Glucose Monitoring System.

The AP-1010multi Blood Glucose Monitoring System consists of three main products: the meter, test strip, and control solutions. These products have been designed, tested, and proven to work together as a system accurate blood glucose test results. Use only AP-1010multi test strips and MAJOR control solution with the AP-1010multi Blood Glucose Monitoring System.

The AP-1020 Blood Glucose Monitoring System consists of three main products: the meter, test strip, and control solutions. These products have been designed, tested, and proven to work together as a system accurate blood glucose test results. Use only AP-1020 test strips and MAJOR control solution with the AP-1020 Blood Glucose Monitoring System.

The AP-1020multi Blood Glucose Monitoring System consists of three main products: the meter, test strip, and control solutions. These products have been designed, tested, and proven to work together as a system accurate blood glucose test results. Use only AP-1020multi test strips and MAJOR control solution with the AP-1020multi Blood Glucose Monitoring System.

#### 5. Substantial Equivalence Information

A. Predicate device name: AP-1000 Blood Glucose Monitoring System

- B. Predicate K number: k090389
C. Comparison with predicate:

The modified AP-1010, AP-1010multi, AP-1020, and AP-1020multi Blood Glucose Monitoring System have the following similarities to the predicate device:

- same operating principle,
- same fundamental scientific technology, .
- incorporate the same basic circuit design,
- incorporate the same materials,
- same shelf life 프
- same software validation
- packaged using the same materials, and
- manufactured by same process

The modifications encompass:

- engineering change in the mechanical appearance of the device and name change
### 6. Test Principle

The detection and measurement of glucose in blood is by an electrochemical biosensor technology

{3}------------------------------------------------

using glucose oxidase.

# 7. Performance Characteristics

AP-1010, AP-1010multi, AP-1020, and AP-1020multi Blood Glucose Monitoring System has the same performance characteristics as the predicate device.

Software verification and validation testing confirmed that the performance, safety and effectiveness of the AP-1010, AP-1010multi, AP-1020, and AP-1020multi Blood Glucose Monitoring System are equivalent to the predicate device.

#### 8. Conclusion

Based on the information provided in this submission, the AP-1010, AP-1010multi, AP-1020, and AP-1020multi Blood Glucose Monitoring System is substantially equivalent to the predicate AP-1000 Blood Glucose Monitoring System.

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

# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of two main elements: a circular seal containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" and a stylized symbol resembling an abstract caduceus or a bird-like figure. The seal surrounds the symbol, creating a unified emblem representing the department.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993

Bestgen Biotech Corp. c/o Steven Shen Q.A./Regulatory Affairs Manager 7f, No 186, Jian-Yi Road, Jung-He, Taipei County China (TAIWAN) 235

FEB 1 0 2012

# Re: k103044

Re: k103044
Trade/Device Name: AP-1010/AP-1010multi and AP-1020/AP-1020multi Blood Glucose Monitoring Systems

Regulation Number: 21 CFR 862.1345 Regulation Name:Glucose test system. Regulatory Class: II Product Code: NBW, CGA Dated: December 16, 2011 Received: December 16, 2011

Dear Mr. Shen:

We have reviewed your Section 510(k) premarket notification of intent to market the We have leviewed your Section 310(t) projection is substantially equivalent (for device felefenced above and have development to legally marketed predicate devices.
the indications for use stated in the enclosure) to legally marketed predicate of the the indications for use stated in the encreases, 1976, the enactment date of the marketed in mersiale commerce prior to they == that have been reclassified in accordance Medical Device Amendments, of to Gevece Inc. Act (Act) that do not require
with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require with the provisions of the Federal Pood, Drag, MA). You may, therefore, market the approval of a premarker approval upproval upprovisions of the Act. The general controls device, subject to the general controls provisions dal registration, listing of devices, good provisions of the Act mender requirements for unitial organding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations (CEF (PMA), it may be subject to such adultional connects and regulations (CFR), Parts affecting your device can be found in This 21, Geas of Courter. in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does Please be advised fill PDA s Issualled of a success of a success or more and not mean that FDA has made a determinations and regulations administered by other requirements of the Act of any recent stately with all the Act's requirements, including, but not
Federal agencies. You must connect of a compare of CER Parts 801 and Federal agencies. You must compry with and 007); labeling (21 CFR Parts 801 and limited to: registration and listing (21 Cr (1 (1 ) (1 ) (1 c = elated adverse events) (21 809); medical device reporting treporting tractice requirements as set forth in the quality
CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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

# Page 2

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/Medical

Devices/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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm

Sincerely yours,

Countney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

{6}------------------------------------------------

# Indication for Use

# 510(k) Number (if known): k103044

# Device Name: AP - 1010 Blood Glucose Monitoring System

Indication For Use:

The AP - 1010 Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger. The AP - 1010 Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. The AP - 1010 Blood Glucose Monitoring System is intended for self testing outside the body (in vitro diagnostic use) by people with diabetes at home as aid to monitor the effectiveness of diabetes control. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.

The AP - 1010 Blood Glucose Test Strips are intended for the quantitative measurement of glucose in fresh capillary whole blood sample drawn from the fingertips. AP - 1010 Blood Glucose Test Strips must be used with the AP - 1010 Blood Glucose Meter. Testing is done outside the body (In Vitro diagnostic use). It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.

Prescription Use (21 CFR Part 801 Subpart D) And/Or

Over the Counter Use X (21 CFR Part 801 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)

1 A

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

{7}------------------------------------------------

# 510(k) Number (if known): k103044

Device Name: AP-1010multi Blood Glucose Monitoring System

Indication For Use:

The AP - 1010multi Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger. The AP - 1010multi Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use) and is intended for multi - patient use in professional healthcare settings as an aid to monitor the effectiveness of diabetes control program. This system should only be used with single - use lancing devices. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.

The AP - 1010multi Blood Glucose Test Strips are intended for the quantitative measurement of glucose in fresh capillary whole blood sample drawn from the fingertips. AP - 1010multi Blood Glucose Test Strips must be used with the AP - 1010multi Blood Glucose Meter. Testing is done outside the body (In Vitro diagnostic use). This system should only be used with single - use lancing devices. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.

Prescription Use X (21 CFR Part 801 Subpart D) And/Or

Over the Counter Use X (21 CFR Part 801 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)

Signature

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

{8}------------------------------------------------

# 510(k) Number (if known): k103044

### Device Name: AP-1020 Blood Glucose Monitoring System

The AP - 1020 Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger. The AP - 1020 Blood Glucose Monitoring System is intended to be used by a single person and should not be shared. The AP - 1020 Blood Glucose Monitoring Systems is intended for self testing outside the body (in vitro diagnostic use) by people with diabetes at home as aid to monitor the effectiveness of diabetes control. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.

The AP - 1020 Blood Glucose Test Strips are intended for the quantitative measurement of glucose in fresh capillary whole blood sample drawn from the fingertips. AP - 1020 Blood Glucose Test Strips must be used with the AP - 1020 Blood Glucose Meter. Testing is done outside the body (In Vitro diagnostic use). It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.

Prescription Use (21 CFR Part 801 Subpart D) And/Or

Over the Counter Use X (21 CFR Part 801 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OVD)

Signature

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

{9}------------------------------------------------

# 510(k) Number (if known): k103044

### Device Name: AP-1020multi Blood Glucose Monitoring System

The AP - 1020multi Blood Glucose Monitoring System is intended for use in the quantitative measurement of glucose in fresh capillary whole blood from the finger. The AP - 1020multi Blood Glucose Monitoring System is intended for testing outside the body (in vitro diagnostic use) and is intended for multi - patient use in professional healthcare settings as an aid to monitor the effectiveness of diabetes control program. This system should only be used with single - use lancing devices. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.

The AP - 1020multi Blood Glucose Test Strips are intended for the quantitative measurement of glucose in fresh capillary whole blood sample drawn from the fingertips. AP - 1020multi Blood Glucose Test Strips must be used with the AP - 1020multi Blood Glucose Meter. Testing is done outside the body (In Vitro diagnostic use). This system is only used with single - use lancing devices. It is not intended for the diagnosis of or screening for diabetes mellitus, and is not intended for use on neonates.

Prescription Use X (21 CFR Part 801 Subpart D) And/Or

Over the Counter Use X (21 CFR Part 801 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OVD)

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety