(135 days)
Not Found
No
The summary describes a standard glucose meter system and does not mention any AI or ML components or capabilities.
No.
The device is described as measuring the concentration of glucose in capillary whole blood, which is a diagnostic function, not a therapeutic one.
Yes
The device is designed to "quantitatively measure the concentration of glucose in capillary whole blood," which is a diagnostic measurement.
No
The device description explicitly lists hardware components: a handheld meter, lancet device, and lancets.
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 measurement is performed in vitro (outside the body) on a biological sample (whole blood).
- Device Description: The description mentions components like a handheld meter, test strips, and liquid controls, which are typical for IVD devices used for analyzing biological samples.
- Anatomical Site: The anatomical site is "capillary whole blood," which is a biological sample collected from the body for in vitro analysis.
The core function of the device is to analyze a biological sample in vitro to provide diagnostic information (glucose concentration), which is the defining characteristic of an IVD.
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.
Product codes (comma separated list FDA assigned to the subject device)
NBW
Device Description
The Accu-Chek Active Test System includes a handheld meter, lancet device, lancets, and instructions for use. Test strips and liquid controls may be acquired separately.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
capillary whole blood (implied fingertip from comparison table)
Indicated Patient Age Range
Not Found
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)
Not Found
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.
K011738, K002134, K001993, K992684, K001427
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
Accu-Chek Active Test System
| DEC 0 5 2001 | 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: July 20, 2001 | |
| 2) Device name | Proprietary name: Accu-Chek Active Test System |
| Common name: Blood glucose test system | |
| Classification name: glucose dehydrogenase, glucose | |
| 3) Predicate | |
| device | The Roche Diagnostics Accu-Chek Active Test System is substantially equivalent to other products in commercial distribution intended for similar use. Most notably it is substantially equivalent to the recently cleared version of the same product. In addition, the AST claim described in this 510(k) premarket notification is substantially equivalent to claims cleared for the following medical devices. Lifescan/Inverness One Touch Ultra Test System (K002134-Special)Abbott/Medisense Sof-Tact Test System (K001993-Traditional)Therasense Freestyle Test System (K992684-Traditional)Lifescan/Inverness FastTake Test System (K001427-Special) |
| 4) Device | |
| Description | The Accu-Chek Active Test System includes a handheld meter, lancet device, lancets, and instructions for use. Test strips and liquid controls may be acquired separately. |
| Continued on next page |
.
1
510(k) Summary, Continued
·
| 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. |
|-----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 6) Comparison
to predicate
device | The Accu-Chek Active Test System is substantially equivalent to other
products in commercial distribution intended for similar use. |
2
omparison to Predicate Devices
| Accu-Chek
Active with AST | Accu-Chek
Active | Amira
AtLast | Therasense
Freestyle | Medisense
Sof-Tact | Lifescan One
Touch Ultra | Lifescan
FastTake | |
|-------------------------------------------|--------------------------------------|--------------------------------------|--------------------------------------|-------------------------------------------|---------------------------------------|------------------------------------------|------------------------------------------|
| 510(k)
(T) = Trad.
(S) = Special | K011738 (S) | K982076 (T) | K992684 (T)
& K000582 (S) | K001993 (T) | K002134 (S) | K001427 (S) | |
| 510(k) Sponsor
Intended Use | Roche
Blood glucose
monitoring | Roche
Blood glucose
monitoring | Amira
Blood glucose
monitoring | Therasense
Blood glucose
monitoring | Abbott
Blood glucose
monitoring | Inverness
Blood glucose
monitoring | Inverness
Blood glucose
monitoring |
| OTC sale | Yes | Yes | Yes | Yes | Yes | Yes | Yes |
| Minimum sample
volume required
(µL) | 1 | 1 | 2 | 0.3 | 3 | 1 | 1.5 |
| Fingertip | Yes | Yes | No | Yes | Yes | Yes | Yes |
| AST | Yes | No | Yes | Yes | Yes | Yes | Yes |
| AST limited to
forearm only | Yes | NA | No | No | No | Yes | Yes |
| Underdosing
detection | Yes | Yes | Yes | Yes | No | No | Yes |
21
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three curved lines representing its body and wings. The eagle is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular fashion around the eagle.
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
DEC 0 5 2001
Re: K012324
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 Dated: November 8, 2001 Received: November 13, 2001
Dear Mr. Flis:
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 1 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/cdrb/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): 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.
(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 Devices | |
| 510(k) Number | K012324 |
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter Use
(Optional Format 1-2-96)