(109 days)
Not Found
No
The description details a standard amperometric blood glucose monitoring system and does not mention any AI or ML components.
No.
The device is an in vitro diagnostic device used to measure glucose levels for monitoring diabetes, not for treatment.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states "in vitro diagnostic use" and that it is "used for quantitative measurement of glucose level in fresh capillary whole blood samples". While it is noted that it "should not be used for the diagnosis of diabetes", the primary function is to measure a biological marker to aid in monitoring a health condition, which falls under the definition of a diagnostic device, specifically for managing an existing condition.
No
The device description explicitly states that the system consists of a blood glucose meter, test strips, control solutions, lancing device, and lancets, which are all hardware components.
Based on the provided text, the device is indeed an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section clearly states: "ADVOCATE® Redi-Code* BMB-EA001S Blood Glucose Monitoring System is intended for use outside the body (in vitro diagnostic use) at home."
- Function: The device is used for the "quantitative measurement of glucose level in fresh capillary whole blood samples," which is a diagnostic test performed on a biological sample outside of the body.
- Components: The system includes a meter, test strips, and control solutions, all typical components of an IVD system for blood glucose monitoring.
Therefore, the text explicitly identifies the device as an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
ADVOCATE® Redi-Code* BMB-EA001S Blood Glucose Monitoring System is intended for use outside the body (in vitro diagnostic use) at home. It is used for quantitative measurement of glucose level in fresh capillary whole blood samples (from the finger, the palm, the forearm, the upper arm, the calf, and the thigh). The alternative site testing can be only used during steady-state blood glucose monitoring. The ADVOCATE® Redi-Code* BMB-EA001S Blood Glucose Monitoring System is intended for use by a single person and should not be shared. In additional, it is intended for use at home as an aid in monitoring the effectiveness of diabetes control program. It should not be used for the diagnosis of diabetes, or for the testing of neonates.
The ADVOCATE® Redi-Code* BMB-EA001S Blood Glucose Monitoring Systems consists of the ADVOCATE® Redi-Code+ BMB-EA001S Blood Glucose meter and the ADVOCATE® Redi-Code BMB-BA006A Blood Glucose test strips. The ADVOCATE® Redi-Code* BMB-EA001S meter are used only with ADVOCATE® Redi-Code+ BMB-BA006A Blood Glucose test strips to quantitatively measure glucose in fresh capillary whole blood samples drawn from finger tips, the palm, the forearm, the upper arm, the calf, and the thigh. The meter also included speaking functions but has not been validated for use by the visually impaired.
The ADVOCATE® Redi-Code* control solutions are for use with the ADVOCATE® Redi-Code* BMB-EA001S Blood Glucose Monitoring System as a quality control check to verify the accuracy of blood glucose test results.
Product codes (comma separated list FDA assigned to the subject device)
NBW, CGA, JJX
Device Description
The ADVOCATE® Redi-Code* BMB-EA001S Blood Glucose Monitoring System consists f the ADVOCATE® Redi-Code BMB-EA004S Blood Glucose meter and the ADVOCATE® Redi-Code* BMB-BA006A Blood Glucose test strips, ADVOCATE® Redi-Code control solutions, lancing device, and commercially available sterilized lancets. This system utilizes amperometric method to generate a current. The size of the current is proportional to the amount of glucose presented in the sample, providing a quantitative measure of glucose level in whole blood.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
finger, the palm, the forearm, the upper arm, the calf, and the thigh
Indicated Patient Age Range
Not Found
Intended User / Care Setting
single person, at home
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The performance of the ADVOCATE® Redi-Code* BMB-EA001S Blood Glucose Monitoring System was studied in the laboratory and in clinical settings. The studies have demonstrated that this system meets the performance requirements of its intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
Not Found
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).
Not Found
§ 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
K12018 3
MAY 1 1 2012
510(k) Summary (Per 21 CFR 807.92)
- l. Submitter Information Company Name Address
| Contact Person | |
|---|---|
| Phone | |
| Fax | |
Date Prepared
-
- Device Name Proprietary Name
Common Name Classification Number
- Device Name Proprietary Name
Classification Panel Product Code Regulation Number
-
- Predicate Device Proprietary Name
Common Name Manufacturer 510(k) Number
- Predicate Device Proprietary Name
BroadMaster Biotech Corporation 7F, NO. 168-2 , Liancheng Rd , Zhonghe Dist , New Taipei City 235 , Taiwan ( R.O.C ) Roger Lai/Blanc Lin 886-987-111105/886-2-66375859 886-2-22428332 roger@broadmaster-biotech.com blanc@broadmaster-biotech.com 2012/1/20
ADVOCATE® Redi-Code+ BMB-EA001S Blood Glucose Monitoring System Blood Glucose Test System System, Test, Blood Glucose, Over the Counter 75, Clinical Chemistry NBW, CGA 21 CFR 862.1345 Glucose Test System
Glucose Shepherd Blood Glucose Monitoring System Blood Glucose Test System BroadMaster Biotech Corporation K102316
4. Device Description
The ADVOCATE® Redi-Code* BMB-EA001S Blood Glucose Monitoring System consists f the ADVOCATE® Redi-Code BMB-EA004S Blood Glucose meter and the ADVOCATE® Redi-Code* BMB-BA006A Blood Glucose test strips, ADVOCATE® Redi-Code control solutions, lancing device, and commercially available sterilized lancets. This system utilizes amperometric method to generate a current. The size of the current is proportional to the amount of glucose
1
presented in the sample, providing a quantitative measure of glucose level in whole blood.
Intended Use
ADVOCATE® Redi-Code* BMB-EA001S Blood Glucose Monitoring System is intended for use outside the body (in vitro diagnostic use) at home. It is used for quantitative measurement of glucose level in fresh capillary whole blood samples (from the finger, the palm, the forearm, the upper arm, the calf, and the thigh). The alternative site testing can be only used during steady-state blood glucose monitoring. The ADVOCATE® Redi-Code* BMB-EA001S Blood Glucose Monitoring System is intended for use by a single person and should not be shared. In additional, it is intended for use at home as an aid in monitoring the effectiveness of diabetes control program. It should not be used for the diagnosis of diabetes, or for the testing of neonates.
The ADVOCATE® Redi-Code BMB-EA001S Blood Glucose Monitoring Systems consists of the ADVOCATE® Redi-Code+ BMB-EA001S Blood Glucose meter and the ADVOCATE® Redi-Code* BMB-BA006A Blood Glucose test strips. The ADVOCATE® Redi-Code+ BMB-EA001S meter are used only with ADVOCATE® Redi-Code BMB-BA006A Blood Glucose test strips to quantitatively measure glucose in fresh capillary whole blood samples drawn from finger tips, the palm, the forearm, the upper arm, the calf, and the thigh. The ADVOCATE® Redi-Code * BMB-EA001S Blood Glucose Meter also includes speaking functions but has not been validated for use by the visually impaired.
The ADVOCATE® Redi-Code* control solutions are for use with the ADVOCATE® Redi-Code* BMB-EA001S Blood Glucose Monitoring System as a quality control check to verify the accuracy of blood glucose test results.
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2
| 5. Comparison to Predicate Device | ||
|---|---|---|
| Item | Candidate device | Predicate device |
| ADVOCATE® Redi-Code+ | ||
| BMB-EA001S Blood Glucose | ||
| Monitoring System | K102316 | |
| Similarities and Differences | ||
| Appearance | Image: ADVOCATE Redi-Code | Image: Bread Master |
| Similarities | ||
| Intended use | Same for both systems. | |
| Enzyme | Glucose Oxidase, same formula and strip design for both systems | |
| Test strips | Same, BMB-BA006A test strips are for the use with both systems | |
| Test sample (finger, | ||
| arm...) | Same for both systems, fresh capillary whole blood | |
| (finger ,palm, forearm, upper arm, calf and thigh) | ||
| Measuring range | Same for both systems, 20-600 mg/dL | |
| Hematocrit | Same for both systems, 20-60% | |
| Required sample volume | Same for both systems, 1.1μL | |
| Reaction time | Same for both systems, 5 seconds | |
| Coding function | Same for both systems, no coding | |
| Operation condition | 50°F~104°F | |
| Below 85% R.H. | ||
| MCU | TI MSP430 | |
| Algorithm (Blood | ||
| glucose concentration | ||
| calculation) | Same | |
| The core circuit for the | Same | |
| measurement | ||
| Power source | Two 1.5V AAA alkaline batteries | |
| Weight (without | ||
| batteries) | 53g | |
| Memory | 400 measurements | |
| Dimension(mm) | 649529 | |
| LCD display | Image: LCD display | |
| General/ Pre-meal/ | ||
| Post-meal selection | Same for both systems | |
| Precision | Same precision for both systems. Please refer to | |
| Attachment 12.1 Precision Study | ||
| Linearity | Same linearity for both systems. Please refer to | |
| Attachment 12.2 Linearity Study | ||
| Accuracy | Same accuracy for both systems. Please refer to | |
| Attachment 13.1 System Accuracy Study | ||
| Lay user evaluation | Attachment 13.3 Customer and | |
| Alternate Site Testing | ||
| Performance Evaluation. | ||
| Speaking Function Evaluation | ||
| Report, indicating the speaking | ||
| function really increase the users' | ||
| convenience, is also attached. | Easy to be used. | |
| Interference | Same interference as the table listed in K102316. When tested | |
| following NCCLS guidelines, bilirubin, creatinine, methyldopa, | ||
| galactose, maltoase, xylose, salicylate, cholesterol,hemoglobinand | ||
| triglycerides at therapeutic concentrations do not significantly affect | ||
| glucose results. However, these levels of the following interferences | ||
| in blood may cause inaccurate test results: | ||
| Acetaminophen $\geq$ 12.5 mg/dL (Therapeutic level is 1.2-3.6 mg/dL) | ||
| Ascorbic acid $\geq$ 7.5 mg/dL(Therapeutic level is 0.4-2.1 mg/dL) | ||
| Dopamine $\geq$ 3 mg/dL (Therapeutic level is 0.04 mg/dL) | ||
| L-dopa $\geq$ 4 mg/dL (Therapeutic level is 0.02-0.3 mg/dL) | ||
| Tolbutamide≥ 150 mg/dL (Therapeutic level is 3.6-7.2 mg/dL) | ||
| Uric acid ≥20 mg/dL (Normal level is 2.6-7.2 mg/dL) | ||
| Gentisic acid ≥ 25 mg/dL (Therapeutic level is 0.2-0.6 mg/dL) | ||
| Tolazamide ≥ 15 mg/dL (Therapeutic level is 2.0-2.5 mg/dL) | ||
| Mannose≥250 mg/dL(Therapeutic level is 1.15 mg/dL) | ||
| Ibuprofen≥ 50 mg/dL(Therapeutic level is 1.0-7.0 mg/dL) | ||
| Disinfectant Protocol | Same disinfectant protocol has been verified to work for both | |
| systems | ||
| Altitude | Same altitude, up to 10745 feet. | |
| EMC testing | IEC 61326-1:2005 | IEC 61326-1:2005 |
| EN 61326-1:2006 | EN 61326-1:2006 | |
| IEC 61326-2-6:2005 | IEC 61326-2-6:2005 | |
| EN 61325-2-6:2006 | EN 61325-2-6:2006 | |
| (TUV Rheinland ,Registration | ||
| No.: AK 50221354 0001) | (TUV Rheinland ,Registration | |
| No.: AK 50186220 0001) | ||
| Glucose meter software | Blood glucose detection and data analysis algorithm is identical. | |
| (See “Attachment 13.2 Method Comparison Report”) | ||
| Control solutions cleared | ||
| in 510(k) # | Same control solution level 1/2/3 | |
| Difference | ||
| User manual (mark | ||
| differences in red when | ||
| compared with the | ||
| predicate) | Please refer to the section marked in red in the user manual | |
| Readability assessment | ||
| for labeling material | ||
| (User manual; test strip | ||
| insert, control solutions | ||
| insert) | The only difference of the labeling material is the section regarding | |
| the meter speaking function in the user manual. Per the evaluation | ||
| report from Arkansas it shows users have met no problem when | ||
| reading the material. | ||
| Color and Material for | ||
| the housing and button | Red ABS | Blue ABS |
| Additional function-- | ||
| English/Spanish | ||
| Speaking Instruction | Yes | No |
| Battery Life | Over 500 times | Over 1000 times |
3
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.
4
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રાદ
・
. . . .
5
6. Performance Studies
The performance of the ADVOCATE® Redi-Code* BMB-EA001S Blood Glucose Monitoring System was studied in the laboratory and in clinical settings. The studies have demonstrated that this system meets the performance requirements of its intended use.
7. Conclusion
The laboratory testing results, clinical testing results and labeling of ADVOCATE® Redi-Code* BMB-EA001S Blood Glucose Monitoring System match the Indications for Use and support the claim of substantial equivalence to the predicate.
6
Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized emblem that resembles an abstract representation of a human figure or a caduceus, a symbol often associated with medicine and healthcare.
10903 New Hampshire Avenue Silver Spring, MD 20993
Broadmaster Biotech Corperation c/o Roger Lai 7F, No. 168-2, Liancheng Rd Zhonghe Dist. New Taipei City 23553 Taiwan (R.O.C) China
MAY 1 1 2012
K120183 Re:
K120183
Trade Name: Advocate® Redi-Code+ BMB-EA001S Blood Glucose Monitoring
System Regulation Number: 21 CFR §862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Codes: NBW, CGA, JJX Dated: April 10, 2012 Received: April 11, 2012
Dear Mr. Lai:
We have reviewed your Section 510(k) premarket notification of intent to market the device is We have reviewed your Section >>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>>> referenced above and have detemmed the benefits substance of cadicate devices marketed in
indications for use stated in the enclosure) to legally marketed in
the enclosed in indications for use stated in the enclosure) to tegally manaded portuges of the Medical Device
interstate commerce prior to May 28, 1976, the enactment of the provisio interstate commerce prior to May 23, 1976, the eniace with the provisions of
Amendments, or to devices that have been receassified in accordance with the provisions of Amendments, or to devices that have been fectassined in actrequire approval of a premarket
the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of the Federal Food, Drug, and Cosmetic Act (Act (Act ) the device, subject to the general
approval application (PMA). You may, therefore, market the device, subject to the gen approval application (PMA). controls provisions of the Act. Ine general controls provisems of the entrols practice,
requirements for annual registration, listing of devices, good manufacturing practic requirements for annual registration, nomig and adulteration.
labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III
n affective and control and colditional controls. Existing major regulations af If your device is classified (see above) into eline) in (opermajor regulations affecting
(PMA), it may be subject to such additional controls. Existing major regulations (CF (PMA), it may be subject to such additional Colliols: Existing mayor roger roger of S00 to 895.
your device can be found in Title 21, Code of Federal Regulations (CFR), Part your device can be found in Title 21, Code of Federal Regulation (400),
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 Please be advised that FDA's issuance of a substantial equirements
mean that FDA has made a determination that your device with other requirements. mean that FDA has made a determination intributions administered by other Federal agencies.
of the Act or any Federal stations and regulations and not limited to: registratio of the Act or any Federal stantify and regulations administered of on the Act of registration
You must comply with all the Act's requirements, including, but not limited to: You must comply with all the Act S requirements, including of the more of the senses of the senses
and listing (21 CFR Part 807); Incience related adverse exemps) (21 CFR 803 and listing (21 CFR Part 807); labeling (21 CFR Pars overs) (21 CFR 803); and good
reporting (reporting of medical devices ast fark in the quality systems (QS) regulation reporting (reporting of medical device-related adverse evenis) (21 UN 000), in any former
manufacturing practice requirements as set forth in the quality systems (OS) regulat CFR Part 820).
7
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 (301) 796-5450. 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 (301) 796-5760. 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 (800) 638-2041 or (301) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm
Sincerely yours,
signature
Couriney 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
8
510(k) Number K120183
Device Name:
ADVOCATE® Redi-Code* BMB-EA001S Blood Glucose Monitoring System
Indications For Use:
ADVOCATE® Redi-Code* BMB-EA001S Blood Glucose Monitoring System is intended for use outside the body (in vitro diagnostic use) at home. It is used for quantitative measurement of glucose level in fresh capillary whole blood samples (from the finger, the palm, the forearm, the upper arm, the calf, and the thigh). The alternative site testing can be only used during steady-state blood glucose monitoring. The ADVOCATE® Redi-Code* BMB-EA001S Blood Glucose Monitoring System is intended for use by a single person and should not be shared. In additional, it is intended for use at home as an aid in monitoring the effectiveness of diabetes control program. It should not be used for the diagnosis of diabetes, or for the testing of neonates.
The ADVOCATE® Redi-Code* BMB-EA001S Blood Glucose Monitoring Systems consists of the ADVOCATE® Redi-Code+ BMB-EA001S Blood Glucose meter and the ADVOCATE® Redi-Code BMB-BA006A Blood Glucose test strips. The ADVOCATE® Redi-Code* BMB-EA001S meter are used only with ADVOCATE® Redi-Code+ BMB-BA006A Blood Glucose test strips to quantitatively measure glucose in fresh capillary whole blood samples drawn from finger tips, the palm, the forearm, the upper arm, the calf, and the thigh. The meter also included speaking functions but has not been validated for use by the visually impaired.
The ADVOCATE® Redi-Code* control solutions are for use with the ADVOCATE® Redi-Code* BMB-EA001S Blood Glucose Monitoring System as a quality control check to verify the accuracy of blood glucose test results.
Over-The-Counter Use X AND/OR Prescription Use (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D)
(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)
Quto. Clule-
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety 510(k) 1220183
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