(138 days)
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No
The document describes a standard blood glucose monitoring system using amperometric biosensor technology and pre-programmed calibration. There is no mention of AI, ML, or any related concepts in the device description or intended use.
No.
The device is described as an in-vitro diagnostic device intended for the quantitative measurement of glucose for diabetes management, rather than for direct treatment or therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states, "The ReliOn Ultima Advance Blood Glucose Monitoring System is intended for in-vitro diagnostic use in the quantitative measurement of glucose in fresh whole blood for self-testing by lay users... or by health care professionals." The "Device Description" also reiterates "intended for in vitro diagnostic use."
No
The device description explicitly details hardware components like a meter and test strips, and the technology involves measuring electrical current generated on disposable test strips. This is not a software-only device.
Yes, the provided text explicitly states that the ReliOn Ultima Advance Blood Glucose Monitoring System is an IVD (In Vitro Diagnostic) device.
Here are the key phrases from the text that confirm this:
- "The ReliOn Ultima Advance Blood Glucose Monitoring System is intended for in-vitro diagnostic use..."
- "The RellOn Ultima Advance Blood Glucose Monitoring System is intended for in vitro diagnostic use (i.e., external use only)..."
N/A
Intended Use / Indications for Use
The ReliOn Ultima Advance Blood Glucose Monitoring System is intended for in-vitro diagnostic use in the quantitative measurement of glucose in fresh whole blood for selftesting by lay users (e.g., from the finger, forearm, upper arm or base of thumb), or by health care professionals. It is not intended to be used for testing neonatal blood samples. The ReliOn Ultima Advance system is indicated for home (lay user) or professional use in the management of patients with diabetes.
Product codes (comma separated list FDA assigned to the subject device)
NBW, LFR, JJX
Device Description
The RellOn Ultima Advance Blood Glucose Monitoring System is intended for in vitro diagnostic use (i.e., external use only) and for the quantitative measurement of olucose in fresh capillary whole blood. Both the modified device (ReliOn Ultima Advance Blood Glucose Monitoring System) and its predicate device, i.e. Optium Plus Blood Glucose Test Strips and Precision Xtra Plus Blood Glucose Test Strips (K051213) are indicated for home (lay user) or professional use.
The modified Reil on Ultima Advance Blood Glucose Monitoring System is substantially equivalent in form, firmware, fundamental scientific technology and performance specifications as the predicate system. The ReliOn Ultima Advance system utilizes amperometric biosensor technology to measure current generated on disposable test strips.
No changes to the strip have been made since the last clearance (Optium Plus Blood Glucose Test Strips and Precision Xtra Plus Blood Glucose Test Strips (K051213)). The test strips manufacturing process is unchanged and all the performance characteristics are unchanged. The test strips are designed to quantitatively measure glucose (sugar) in fresh capillary whole blood from the fingerip, forearm, or base of the thumb, by home or professional users. Both the predicate strips (Optium Plus Blood Glucose Test Strips and Precision Xtra Plus Blood Glucose Test Strips (K051213)Jand the ReliOn Ultima Advance Blood Glucose Test Strips use the reagent glucose dehydrogenase with nicotinamide-adenine dinucleotide (GDH-NAD) as co-factor.
The predicate meter uses lot specific calibration information contained on the calibration bar is contained in every box of test strips and is specific to a lot of test strips. The calibration bar contains the lot specific information to allow the meter to convert electrical current into glucose readings via a calibration slope and intercept. The user is instructed to calibrate their meter each time they open and use a new box of test strips.
The ReliOn Ultima Advance meter is programmed with a predetermined calibration slope and there is no requirement for the user to insert a calibration bar into the meter.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
finger, forearm, upper arm or base of thumb
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Home (lay user) or professional use
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)
Not Found
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.
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Enter your 510(k) Summary or Statement.
Bantonnen mension and manumini illiam ministr 510(k) Summary
surement consideraria primer considerary
Per 21 CFR §807.92
NOV 2 6 2008
| Date Prepared: | October 16, 2008 |
|---|---|
| Company | Abbott Laboratories |
| Division | Abbott Diabetes Care Inc. |
| Street Address | 1360 South Loop Road |
| City, State Zip | Alameda, CA 94502 |
| Telephone No. | 510-749-5400 |
| Fax No. | 510-864-4791 |
| Contact Person: | Arul Sterlin |
| Tel No. 510-864-4310 | |
| Fax No. 510-864-4791 | |
| arul.sterlin@abbott.com | |
| Proprietary Name: | ReliOn Ultima Advance Blood Glucose Monitoring System |
Image /page/0/Picture/7 description: The image shows a handwritten text string that appears to be a combination of letters and numbers. The text is written in a cursive style, with some characters being more legible than others. The string starts with the letters 'Ko', followed by 'v', then a slash '/'. After the slash, there are the numbers '975'.
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| Common Name: | Blood Glucose Testing System | |
|---|---|---|
| Classification Name: | Glucose Dehydrogenase, Glucose, Class II (21 CFR§ 862.1345) | |
| Product codes: NBW, LFR, | ||
| Single Analyte Control Solution, Class I | ||
| (21 CFR§ 862.1660) | ||
| Product code: JJX | ||
| Predicate Device: | Optium Plus Blood Glucose Test Strips and Precision | |
| Xtra Plus Blood Glucose Test Strips (K051213) |
Description of the Device:
The RellOn Ultima Advance Blood Glucose Monitoring System is intended for in vitro diagnostic use (i.e., external use only) and for the quantitative measurement of olucose in fresh capillary whole blood. Both the modified device (ReliOn Ultima Advance Blood Glucose Monitoring System) and its predicate device, i.e. Optium Plus Blood Glucose Test Strips and Precision Xtra Plus Blood Glucose Test Strips (K051213) are indicated for home (lay user) or professional use.
The modified Reil on Ultima Advance Blood Glucose Monitoring System is substantially equivalent in form, firmware, fundamental scientific technology and performance specifications as the predicate system. The ReliOn Ultima Advance system utilizes amperometric biosensor technology to measure current generated on disposable test strips.
No changes to the strip have been made since the last clearance (Optium Plus Blood Glucose Test Strips and Precision Xtra Plus Blood Glucose Test Strips (K051213)). The test strips manufacturing process is unchanged and all the performance characteristics are unchanged. The test strips are designed to quantitatively measure glucose (sugar) in fresh capillary whole blood from the fingerip, forearm, or base of the thumb, by home or professional users. Both the predicate strips (Optium Plus Blood Glucose Test Strips and Precision Xtra Plus Blood Glucose Test Strips (K051213)Jand the ReliOn Ultima Advance Blood Glucose Test Strips use the reagent glucose dehydrogenase with nicotinamide-adenine dinucleotide (GDH-NAD) as co-factor.
The predicate meter uses lot specific calibration information contained on the calibration bar is contained in every box of test strips and is specific to a lot of test strips. The calibration bar contains the lot specific information to allow the meter to convert electrical current into glucose readings via a calibration slope and intercept. The user is instructed to calibrate their meter each time they open and use a new box of test strips.
The ReliOn Ultima Advance meter is programmed with a predetermined calibration slope and there is no requirement for the user to insert a calibration bar into the meter.
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Image /page/2/Picture/1 description: The image shows the logo for the United States Department of Health and Human Services. The logo features a stylized eagle with three stripes forming its body and wing. The eagle faces left and is positioned to the right of the text. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Abbott Diabetes Care, Inc. c/o Mr. Arul Sterlin Regulatory Affairs Associate 1360 South Loop Road Alameda, CA 94502
NOV 2 6 2008
Re: K081975
Trade/Device Name: ReliOn Ultima Advance Blood Glucose Monitoring System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose Test System Regulatory Class: II Product Code: NBW, LFR, JJX Dated: October 24, 2008 Received: October 27, 2008
Dear Mr. Sterlin:
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 markcted 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.
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 affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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This letter will allow you to begin marketing your device as described in your Section 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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0490. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its tollofre an (800) 638-2041 or (240) 276-3150 or at its Internet address at http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Jean M. Cooper, M.S., D.V.M.
Jean M. Cooper, M.S., D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indication for Use
510(k) Number (if known): K081975
Device Name: ReliOn Ultima Advance Blood Glucose Monitoring System
Indication For Use:
The ReliOn Ultima Advance Blood Glucose Monitoring System is intended for in-vitro diagnostic use in the quantitative measurement of glucose in fresh whole blood for selftesting by lay users (e.g., from the finger, forearm, upper arm or base of thumb), or by health care professionals. It is not intended to be used for testing neonatal blood samples. The ReliOn Ultima Advance system is indicated for home (lay user) or professional use in the management of patients with diabetes.
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)
Division Sign Off
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) k 081975
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