(20 days)
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.
Instrument Operating Principle -- photometry
Reagent Test Principle -- glucose dehydrogenase
Here's an analysis of the provided information, describing the acceptance criteria and study that proves the device meets those criteria:
Acceptance Criteria and Device Performance Study for Accu-Chek Compact System
1. Table of Acceptance Criteria and Reported Device Performance
The provided document describes modifications to the Accu-Chek Compact System regarding alternate site testing (AST) for self-testing capillary whole blood samples. The key performance characteristic assessed for this modification is the correlation between AST results and finger-prick results.
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Correlation | r > 0.90 | r > 0.90 (between AST results and finger results under steady state conditions) |
Note: The document explicitly states that the "study demonstrated good correlation (r> 0.90) between AST results and finger results under steady state conditions." This indicates that the established acceptance criterion for correlation was r > 0.90. If the reported performance had been "r = 0.91", that would be an exact value, but "r > 0.90" is the reported outcome, matching the implicit criterion.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document does not explicitly state the specific number of samples (participants or blood draws) used in the study. It refers to "results of a study conducted".
- Data Provenance: The study was "conducted at our manufacturing facility." This suggests the data was generated internally by Roche Diagnostics Corporation. The document does not specify the country of origin of the data beyond the manufacturing facility, nor does it explicitly state if it was retrospective or prospective. Given the context of a new 510(k) submission for a device modification, it is most likely a prospectively collected dataset for the purpose of this study.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This type of information is not applicable to this device. The Accu-Chek Compact System is a glucose meter, and its performance is evaluated against a reference method (e.g., laboratory analyzer, or in this case, traditional finger-prick blood glucose results). "Ground truth" for glucose concentration is typically established by highly accurate chemical analysis methods, not by expert consensus in the way a medical image might be interpreted. There is no mention of experts establishing ground truth for this study.
4. Adjudication Method for the Test Set
The concept of an adjudication method (like 2+1 or 3+1) is not applicable to this type of device study. Adjudication is typically used when human interpretation of data (e.g., medical images) is involved, and multiple experts' opinions need to be reconciled to establish a ground truth. For a quantitative device like a glucose meter, the "ground truth" is a measured value or a reference method's measured value, which does not require adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. MRMC studies are relevant for diagnostic devices that involve interpretation by human readers (e.g., radiologists interpreting images). This study focuses on the analytical performance of a glucose meter, specifically its ability to produce consistent results from different sample collection sites compared to a traditional site. There are no "readers" in the context of this study.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, a standalone performance study was done. The study specifically evaluated the "system accuracy with AST blood from calf, thigh and upper arm" relative to finger-prick results. This assesses the device's (instrument and test strips) analytical performance independently of human interpretation of the results for diagnostic purposes. The device itself generates the quantitative glucose value, and the study validates its accuracy against a known reference (finger-prick results for the same individual under steady state). Therefore, it focused on the algorithm's (device's) ability to correctly measure glucose from different sites.
7. The Type of Ground Truth Used
The type of ground truth used was comparison to finger-prick results under steady state conditions. While not explicitly stated as a "true reference method" (like a lab analyzer), the study design implies that finger-prick results were considered the established standard for comparison, from which the AST results were not expected to deviate significantly. The aim was to show that "system accuracy with AST blood from calf, thigh and upper arm is unchanged from forearm," suggesting that the existing accuracy relative to finger-prick (and likely a lab reference) was maintained.
8. The Sample Size for the Training Set
The document does not provide any information about a specific "training set" or its sample size. This is common for this type of device submission. Glucose meters are typically developed and validated using well-established chemical principles and analytical performance studies. While there's an underlying process of calibrating and verifying the device's algorithms, the 510(k) submission typically focuses on the final validation study's performance, not the individual stages of internal algorithm development and "training" as might be described for AI/ML models.
9. How the Ground Truth for the Training Set Was Established
As no training set is mentioned, information on how its ground truth was established is not provided and is likely not applicable in the context of this 510(k) summary. The development of glucose measurement algorithms relies on chemical principles and calibration against highly accurate laboratory reference methods, rather than human-labeled ground truth datasets in the way AI models are trained.
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JUL 2 3 2002
| 510(k) Summary | K022171 |
|---|---|
| Introduction | According to the requirements of 21 CFR 807.92, the following informationprovides sufficient detail to understand the basis for a determination ofsubstantial equivalence. |
| 1) Submittername, address,contact | Roche Diagnostics Corporation9115 Hague Rd.Indianapolis, IN 46250(317) 845-2000Contact Person: Scott ThielDate Prepared: July 2, 2002 |
| 2) Device name | Proprietary name: Accu-Chek Compact SystemClassification name: Glucose Dehydrogenase, Glucose(21 C.F.R. § 862.1345)(75LFR) |
| 3) Predicatedevice | We claim substantial equivalence to the current legally marketed Accu-ChekCompact System (K004010). |
| 4) DeviceDescription | Instrument Operating Principle -- photometryReagent Test Principle -- glucose dehydrogenase |
| 5) Intended use | The Accu-Chek Compact system is designed to quantitatively measure theconcentration of glucose in capillary and venous whole blood. The device isindicated for professional use and over-the-counter sale. |
| The Accu-Chek Compact system is indicated for lay person use with capillarywhole 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 measurethe concentration of glucose in whole blood. The test device is indicatedfor professional use and over-the-counter sale. This device is not suitablefor testing neonate samples. |
| Test principle | Glucose dehydrogenase chemical reaction. The instrument measures theextent of color change (photometric) caused by the presence of glucose inthe sample. The amount of color change is related to the glucoseconcentration in the blood sample. |
| Monitor codingprocedure | The code is automatically read from the test drum upon insertion of thetest drum into the meter. |
| Test strip storageconditions | Store at room temperature between +36° F(+2° C) and +86° F(+30° C). |
| Test strip operatingconditions | Between +50° F(+10° C) and +104° F(+40° C). |
| Quality controlacceptable range | The mean is strip lot specific and will be determined individually. Therange of the controls is within ± 15 mg/dL or ± 15% compared to thedetermined mean. |
| Labelinginstructionsregarding expectedresults | The normal fasting adult blood glucose range for a non-diabetic is 70-105mg/dL. One to two hours after meals, normal blood glucose levels shouldbe less than 140 mg/dL. Doctors will determine the range that isappropriate for the patients. |
| Labelinginstructionsregarding responseto unusual results | Run a quality control test, if the result is outside the acceptable QCrecovery range contact Roche Diagnostics's Accu-Chek Customer Carecenter; if result is within the acceptable range, review proper testingprocedure and repeat blood glucose test with a new test strip. |
| Acceptable sampletypes | Capillary and venous whole blood samples |
19
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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
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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
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510(k) Summary, Continued
Difference
| Feature | Accu-Chek Compact System(modified) | Accu-Chek Compact System(predicate) |
|---|---|---|
| Self-testingcapillary wholeblood samplecollection sites | Finger, forearm, calf, thigh, upperarm, 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.
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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.
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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
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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
§ 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.