(20 days)
Not Found
No
The document describes a photometric glucose meter and does not mention any AI or ML terms, image processing, or data sets typically associated with AI/ML development.
No
The device measures glucose levels, which is a diagnostic function, not a therapeutic one. Therapeutic devices are designed to treat or alleviate an illness or injury.
Yes
The device is described as quantitatively measuring the concentration of glucose in blood, which is a diagnostic measurement used to identify or monitor a medical condition (diabetes).
No
The device description explicitly mentions "Instrument Operating Principle -- photometry" and "Reagent Test Principle -- glucose dehydrogenase," indicating the use of hardware components (photometer) and chemical reagents, which are not characteristic of a software-only medical device.
Yes, based on the provided information, the Accu-Chek Compact system is an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The primary intended use is to "quantitatively measure the concentration of glucose in capillary and venous whole blood." This is a classic definition of an in vitro diagnostic test, as it analyzes a biological sample (blood) outside of the body to provide diagnostic information (glucose concentration).
- Device Description: The operating principle (photometry) and reagent test principle (glucose dehydrogenase) are methods used to analyze the chemical composition of the blood sample, which is characteristic of IVD devices.
- Anatomical Site: The device uses blood samples drawn from various anatomical sites, further confirming that it is analyzing a biological specimen.
The fact that it is indicated for both professional and lay person use, and sold over-the-counter, does not negate its classification as an IVD. Many IVD devices are designed for home use.
N/A
Intended Use / Indications for Use
The Accu-Chek Compact system is designed to quantitatively measure the concentration of glucose in capillary and venous whole blood. The device is indicated for professional use and over-the-counter sale.
The Accu-Chek Compact system is indicated for lay person use with capillary whole blood samples drawn from the fingertips, forearm, upper arm, thigh, calf, and palm.
Product codes
NBW, LFR
Device Description
Instrument Operating Principle -- photometry
Reagent Test Principle -- glucose dehydrogenase
Mentions image processing
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.
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Capillary and venous whole blood samples from the fingertips, forearm, upper arm, thigh, calf, and palm.
Indicated Patient Age Range
The Accu-Chek Compact system 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.
Intended User / Care Setting
professional use and over-the-counter sale.
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
good correlation (r> 0.90)
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
JUL 2 3 2002
| 510(k) Summary | K022171 |
|---|---|
| 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: Scott Thiel | |
| Date Prepared: July 2, 2002 | |
| 2) Device name | Proprietary name: Accu-Chek Compact System |
| Classification name: Glucose Dehydrogenase, Glucose | |
| (21 C.F.R. § 862.1345)(75LFR) | |
| 3) Predicate | |
| device | We claim substantial equivalence to the current legally marketed Accu-Chek |
| Compact System (K004010). | |
| 4) Device | |
| Description | Instrument Operating Principle -- photometry |
| Reagent Test Principle -- glucose dehydrogenase | |
| 5) Intended use | The Accu-Chek Compact system is designed to quantitatively measure the |
| concentration of glucose in capillary and venous whole blood. The device is | |
| indicated for professional use and over-the-counter sale. | |
| The Accu-Chek Compact system is indicated for lay person use with capillary | |
| whole blood samples drawn from the fingertips, forearm, upper arm, thigh, | |
| calf, and palm. | |
| Continued on next page | |
| Feature/Claim | Detail |
| Intended use | The Accu-Chek Compact system 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. | |
| Monitor coding | |
| procedure | The code is automatically read from the test drum upon insertion of the |
| test drum into the meter. | |
| Test strip storage | |
| conditions | Store at room temperature between +36° F(+2° C) and +86° F(+30° C). |
| Test strip operating | |
| conditions | Between +50° F(+10° C) and +104° F(+40° C). |
| Quality control | |
| acceptable range | The mean is strip lot specific and will be determined individually. The |
| range of the controls is within ± 15 mg/dL or ± 15% compared to the | |
| determined mean. | |
| Labeling | |
| instructions | |
| regarding expected | |
| results | The normal fasting adult blood glucose range for a non-diabetic is 70-105 |
| mg/dL. One to two hours after meals, normal blood glucose levels should | |
| be less than 140 mg/dL. Doctors will determine the range that is | |
| appropriate for the patients. | |
| Labeling | |
| instructions | |
| regarding response | |
| to unusual results | Run a quality control test, if the result is outside the acceptable QC |
| recovery range contact Roche Diagnostics's Accu-Chek Customer Care | |
| center; if result is within the acceptable range, review proper testing | |
| procedure and repeat blood glucose test with a new test strip. | |
| Acceptable sample | |
| types | Capillary and venous whole blood samples |
19
1
510(k) Summary, Continued
The proposed modification is relatively modest in scope. All of the following 6) Similarities are claims and features unaffected by the proposed modification.
Continued on next page
2
510(k) Summary, Continued
Similarities,
Contd.
| Reportable range | 10-600 mg/dL |
|---|---|
| Hematocrit range | 25 – 65% |
| Warnings and precautions | For in vitro diagnostic use only. |
| Reagent active ingredients | Glucose-dye-oxidoreductase* Bis-(2-hydroxyethyl)-(4-hydroximinocyclohexa-2,5-dienylidene)-ammonium chloride 2,18-Phosphomolybdic acid *(from A. Calcoaceticus, recombinant from E. Coli) |
| Minimum sample volume | 3.5 µL |
| Under-dosed test strip detection method | Yes |
| Dosing test strips outside of meter | No |
| Meter physical dimensions | 4" L x 2" W x 1 1/2" H |
| Batteries required | Two 1.5 volt AAA alkaline batteries |
| Data transmission to external devices | Yes |
and the comments of the comments of the contraction of the contribution of the contribution of the contribution of the contribution of the contribution of the contribution of
Continued on next page
3
510(k) Summary, Continued
Difference
| Feature | Accu-Chek Compact System
(modified) | Accu-Chek Compact System
(predicate) |
|---------------------------------------------------------------------|------------------------------------------------------|-----------------------------------------|
| Self-testing
capillary whole
blood sample
collection sites | Finger, forearm, calf, thigh, upper
arm, and palm | Finger |
Performance Characteristics
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.
4
Image /page/4/Picture/0 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 an abstract symbol that resembles three stylized human profiles facing to the right, stacked on top of each other.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 2098 Gaither, Road Rockville MD 20850
JUL 2 3 2002
Mr. Scott Thiel Regulatory Affairs Specialist Roche Diagnostics Corporation 9115 Hague Road P.O. Box 50457 Indianapolis, IN 46250-0457
Re: K022171
Trade/Device Name: Accu-Chek Compact Test System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: NBW: LFR Dated: July 2, 2002 Received: July 3, 2002
Dear Mr. Thiel:
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. Iisting 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.
5
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/cdrb/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
6
Indications for Use Statement
510(k) Number (if known): Device Name: Accu-Chek Compact Test System
Indications for Use:
The Accu-Chek Compact system is designed to quantitatively measure the concentration of glucose in capillary and venous whole blood. The device is indicated for professional use and over-the-counter sale.
The Accu-Chek Compact system is indicated for lay person use with capillary whole blood samples drawn from the fingertips, forearm, upper arm, thigh, calf, and palm.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
Sean Cooper
ivision Sign-Off livision of Clinical Laboratory D 510(K) Number