(28 days)
Not Found
No
The summary describes a photometric glucose meter using glucose dehydrogenase, with no mention of AI, ML, or related concepts.
No
The device is designed to measure glucose levels, not to treat a condition. It provides diagnostic information, which may inform therapeutic decisions, but it is not a therapeutic device itself.
Yes
The device "is designed to quantitatively measure the concentration of glucose in capillary whole blood," which is a measurement used to aid in the diagnosis or monitoring of diabetes.
No
The device description explicitly states "Instrument Operating Principle -- photometry" and "Reagent Test Principle -- glucose dehydrogenase," indicating the use of hardware components (a photometer and chemical reagents) to measure glucose concentration, not just software processing.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the device is designed to "quantitatively measure the concentration of glucose in capillary whole blood." This is a measurement performed in vitro (outside the body) on a biological sample (blood).
- Device Description: The operating principle (photometry) and reagent test principle (glucose dehydrogenase) are methods used to analyze the chemical composition of a sample, which is characteristic of IVD devices.
- Anatomical Site: The device uses "capillary whole blood samples," which are biological specimens collected from the body for analysis.
These points clearly indicate that the Accu-Chek Active system is designed to perform a diagnostic test on a biological sample outside of the body, which is the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Accu-Chek Active system is designed to quantitatively measure the concentration of glucose in capillary whole blood. The device is indicated for professional use and over-the-counter sale.
The Accu-Chek Active system is indicated for use with capillary whole blood samples drawn from the fingertips, forearm, upper arm, thigh, and calf
Product codes (comma separated list FDA assigned to the subject device)
NBW; LFR
Device Description
Instrument Operating Principle -- photometry
Reagent Test Principle -- glucose dehydrogenase
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
capillary whole blood samples drawn from the fingertips, forearm, upper arm, thigh, and calf
Indicated Patient Age Range
This device is not suitable for testing neonate samples.
Intended User / Care Setting
professional use and over-the-counter sale.
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 results of a study conducted at our manufacturing facility demonstrated consistent quality performance of this product. This study demonstrated good correlation (r> 0.90) between AST results and finger results under steady state conditions. With these data it is proved that the system accuracy with AST blood from calf, thigh and upper arm is unchanged from forearm.
| AST Location | Upper Arm | Thigh | Calf |
|---|---|---|---|
| N | 65 | 62 | 64 |
| Range | 58 to 464 | 33 to 434 | 56 to 339 |
| Slope | 1.01 | 0.99 | 1.00 |
| Slope 95% CI | (0.97, 1.05) | (0.95, 1.03) | (0.96, 1.04) |
| Intercept | 0.72 | 7.67 | 7.11 |
| Intercept 95% CI | (-7.86, 9.29) | (-0.97, 16.32) | (-0.46, 14.69) |
| Correlation | 0.984 | 0.983 | 0.982 |
| Std Error | 15.42 | 15.70 | 12.06 |
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Correlation (r> 0.90)
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
JUN 0 3 2002
510(k) Summary
| Introduction | According to the requirements of 21 CFR 807.92, the following information
provides sufficient detail to understand the basis for a determination of
substantial equivalence. |
|-------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1) Submitter
name, address,
contact | Roche Diagnostics Corporation
9115 Hague Rd.
Indianapolis, IN 46250
(317) 845-2000
Contact Person: Mike Flis
Date Prepared: May 2, 2002 |
| 2) Device name | Proprietary name: Accu-Chek Active System
Classification name: SYSTEM, TEST, BLOOD GLUCOSE, OVER THE
COUNTER
(21 C.F.R. § 862.1345)(75NBW) |
| 3) Predicate
device | We claim substantial equivalence to the current legally marketed Accu-Chek
Active System (K012324). |
| 4) Device
Description | Instrument Operating Principle -- photometry
Reagent Test Principle -- glucose dehydrogenase |
| 5) Intended use | The Accu-Chek Active system is designed to quantitatively measure the
concentration of glucose in capillary whole blood. The device is indicated for
professional use and over-the-counter sale. |
| | Continued on next page |
1
510(k) Summary, Continued
- Similarities The proposed modification is relatively modest in scope. All of the following are claims and features unaffected by the proposed modification.
| Feature/Claim | Detail |
|---|---|
| Intended use | The Accu-Chek Active systems is designed to quantitatively measure the |
| concentration of glucose in whole blood. The test device is indicated for | |
| professional use and over-the-counter sale. This device is not suitable for | |
| testing neonate samples. | |
| Test principle | Glucose dehydrogenase chemical reaction. The instrument measures the |
| extent of color change (photometric) caused by the presence of glucose in | |
| the sample. The amount of color change is related to the glucose | |
| concentration in the blood sample. | |
| Warnings and | |
| precautions | For in vitro diagnostic use only. |
| Under-dosed test | |
| strip detection | |
| method | Yes. Includes a third LCD intended solely to detect whether the test pad |
| is sufficiently covered by the blood sample. This design more effectively | |
| identifies under-dosed test strips. | |
| Dosing test strips | |
| outside of meter | Possible |
| AST precautionary | |
| instructions | AST is not recommended: |
| during periods of rapid decreases or increases in blood glucose levels; | |
| – | |
| for people with a history of recurrent hypoglyecmia, who suspect that | |
| their blood glucose is extremely low, or who are unaware of | |
| hypoglycemic events. | |
| Studies show that AST results immediately before a meal and near | |
| bedtime are more similar to fingertip results. |
7) Differences
| Feature | Accu-Chek Active System
(modified) | Accu-Chek Active System
(predicate) |
|-----------------------------------------|------------------------------------------------|----------------------------------------|
| Self-testing sample
collection sites | Finger, forearm, calf, thigh, and
upper arm | Finger and forearm |
Continued on next page
2
510(k) Summary, Continued
8) Data demonstrating substantial equivalence
The results of a study conducted at our manufacturing facility demonstrated consistent quality performance of this product. This study demonstrated good correlation (r> 0.90) between AST results and finger results under steady state conditions. With these data it is proved that the system accuracy with AST blood from calf, thigh and upper arm is unchanged from forearm.
| AST Location | Upper Arm | Thigh | Calf |
|---|---|---|---|
| N | 65 | 62 | 64 |
| Range | 58 to 464 | 33 to 434 | 56 to 339 |
| Slope | 1.01 | 0.99 | 1.00 |
| Slope 95% CI | (0.97, 1.05) | (0.95, 1.03) | (0.96, 1.04) |
| Intercept | 0.72 | 7.67 | 7.11 |
| Intercept 95% | |||
| CI | (-7.86, 9.29) | (-0.97, 16.32) | (-0.46, 14.69) |
| Correlation | 0.984 | 0.983 | 0.982 |
| Std Error | 15.42 | 15.70 | 12.06 |
AST location versus Finger
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized image of an eagle with three human profiles incorporated into its design. The eagle's wings are formed by the profiles, creating a visual representation of the department's focus on both health and human services.
JUN 0 3 2002
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. Mike Flis Regulatory Affairs Principal Roche Diagnostics Corporation 9115 Hague Road P.O. Box 50457 Indianapolis, IN 46250-0457
K021448 Trade/Device Name: Accu-Chek Active Test System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: NBW; LFR Dated: May 2, 2002 Received: May 6, 2002
Dear Mr. Flis:
Re:
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.
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 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); good manufacturing practice requirements as set 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.
4
Page 2 -
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Steven Butman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory-Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use Statement
510(k) Number (if known): K021448 Device Name: Accu-Chek Active Test System
Indications for Use:
The Accu-Chek Active system is designed to quantitatively measure the concentration of glucose in capillary whole blood. The device is indicated for professional use and over-the-counter sale.
The Accu-Chek Active system is indicated for use with capillary whole blood samples drawn from the fingertips, forearm, upper arm, thigh, and calf
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
| Division of Clinical Laboratory | |
| 510(k) Number | K021448 |
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)