(29 days)
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, calf and palm.
Instrument Operating Principle -- photometry
Reagent Test Principle -- glucose dehydrogenase
Here's an analysis of the provided text regarding the Accu-Chek Active System's acceptance criteria and study:
1. Table of Acceptance Criteria and Reported Device Performance
The provided summary focuses on demonstrating that the modified Accu-Chek Active System maintains its accuracy when used with alternate sampling sites (palm) compared to fingertip measurements, and that its performance for existing alternate sites (calf, thigh, upper arm) remains consistent.
Acceptance Criteria for Correlation (Implicit): The study aimed to demonstrate a "substantial correlation (r > 0.90)" between AST (Alternate Site Testing) results and finger results.
Reported Device Performance:
| AST Location | N | Range (mg/dL) | Slope | Slope 95% CI | Intercept | Intercept 95% CI | Correlation (r) | Std Error |
|---|---|---|---|---|---|---|---|---|
| Palm (near thumb) | 65 | 31-371 | 1.031 | (0.994, 1.067) | -0.5 | (-6.7, 5.6) | 0.990 | 11.0 |
| Palm (near small finger) | 65 | 31-371 | 1.019 | (0.978, 1.059) | 1.7 | (-5.1, 8.5) | 0.988 | 12.1 |
Conclusion regarding acceptance criteria: Both palm sampling sites achieved a correlation coefficient (r) of greater than 0.90 (0.990 and 0.988 respectively), indicating that the device met the implicit acceptance criterion for substantial correlation.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 65 subjects for each palm alternate site (palm near thumb and palm near small finger), for a total of 130 samples specifically reported in the table. The phrase "With these data it is proved that the system accuracy with AST blood from calf, thigh and upper arm is unchanged from forearm" suggests additional data might have been collected for these sites, but the detailed statistics are only provided for the palm.
- Data Provenance: The study was "conducted at our manufacturing facility." This suggests it was an internal company study. There is no explicit mention of the country of origin for the data or whether it was retrospective or prospective. Given it's a study demonstrating consistent performance for a modified device, it is most likely a prospective study where samples were actively collected for the purpose of the study.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not provided in the document. For a blood glucose meter, the "ground truth" or reference method is typically an established laboratory reference analyzer, not expert consensus. The document does not specify the reference method used.
4. Adjudication Method for the Test Set
This is not applicable as the ground truth for a blood glucose meter is typically established by a laboratory reference method, not by human expert adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. This document describes a modification to a blood glucose meter, which is an in vitro diagnostic device. It does not involve human readers interpreting images or data, nor does it concern AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Yes, implicitly. The data presented are direct comparisons between the Accu-Chek Active System's readings from different sample sites. The performance metrics (slope, intercept, correlation) describe the device's accuracy without human intervention playing a role in interpreting the result displayed by the meter.
7. The Type of Ground Truth Used
The document does not explicitly state the specific reference method used to establish the "ground truth" or comparator for the finger results. However, for blood glucose meters, the standard ground truth is typically:
- A laboratory reference method (e.g., YSI analyzer, hexokinase method) run on a plasma sample, which is then mathematically converted to whole blood equivalent glucose values.
- Alternatively, the "finger results" from the Accu-Chek Active Meter itself could be considered the reference if the goal was solely to prove equivalence of AST to fingertip measurements with the same meter. The text "AST Sample versus Finger (Same Accu-Chek Active Meter)" suggests that the fingertip measurement from the same device served as the comparator for the AST readings.
8. The Sample Size for the Training Set
This information is not provided. The data presented is for the validation/test set. Blood glucose meters typically do not involve "training sets" in the same way machine learning algorithms do. Development and calibration would involve internal studies, but those are distinct from the validation study described here.
9. How the Ground Truth for the Training Set Was Established
- Not applicable / Information not provided. As mentioned above, a traditional "training set" with ground truth in the context of machine learning is not directly relevant here. For the internal development and calibration of the glucose meter, ground truth would have been established using highly accurate laboratory reference methods.
{0}------------------------------------------------
3 2002 JUL
510(k) Summary
ে
| 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: Mike FlisDate Prepared: |
| 2) Device name | Proprietary name: Accu-Chek Active SystemClassification name: SYSTEM, TEST, BLOOD GLUCOSE, OVER THECOUNTER(21 C.F.R. § 862.1345)(75NBW) |
| 3) Predicatedevice | We claim substantial equivalence to the current legally marketed Accu-ChekActive System (K012324 & K021448) |
| 4) DeviceDescription | Instrument Operating Principle -- photometryReagent Test Principle -- glucose dehydrogenase |
| 5) Intended use | The Accu-Chek Active system is designed to quantitatively measure theconcentration of glucose in capillary whole blood. The device is indicated forprofessional use and over-the-counter sale. The Accu-Chek Active system isindicated for use with capillary whole blood samples drawn from thefingertips, forearm, upper arm, thigh, calf and palm. |
| Continued on next page | |
| 6) Similarities | The proposed modification is relatively modest in scope. All of the following are claims and features unaffected by the proposed modification. |
{1}------------------------------------------------
510(k) Summary, Continued
、
| Feature/Claim | Detail |
|---|---|
| Intended use | The Accu-Chek Active systems is designed to quantitatively measure theconcentration of glucose in whole blood. The test device is indicated forprofessional use and over-the-counter sale. This device is not suitable fortesting 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. |
| Warnings andprecautions | For in vitro diagnostic use only. |
| Under-dosed teststrip detectionmethod | Yes. Includes a third LCD intended solely to detect whether the test padis sufficiently covered by the blood sample. This design more effectivelyidentifies under-dosed test strips. |
| Dosing test stripsoutside of meter | Possible |
| AST precautionaryinstructions | 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 thattheir blood glucose is extremely low, or who are unaware ofhypoglycemic events.Studies show that AST results immediately before a meal and nearbedtime are more similar to fingertip results. |
7) Differences
| Feature | Accu-Chek Active System(modified) | Accu-Chek Active System(predicate) |
|---|---|---|
| Self-testing samplecollection sites | Finger, forearm, calf, thigh, upperarm, and palm | Finger, forearm, calf, thigh, andupper arm |
Continued on next page
{2}------------------------------------------------
510(k) Summary, Continued
- Data The results of a study conducted at our manufacturing facility demonstrated demonstrating consistent quality performance of this product. This study demonstrated good substantial correlation (r> 0.90) between AST results and finger results under steady state equivalence 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 Sample versus Finger (Same Accu-Chek Active Meter)
| AST Location | Palm (near thumb) | Palm (near smallfinger) |
|---|---|---|
| N | 65 | 65 |
| Range (mg/dL) | 31-371 | 31-371 |
| Slope | 1.031 | 1.019 |
| Slope 95% CI | (0.994, 1.067) | (0.978, 1.059) |
| Intercept | -0.5 | 1.7 |
| Intercept 95% CI | (-6.7, 5.6) | (-5.1, 8.5) |
| Correlation | 0.990 | 0.988 |
| Std Error | 11.0 | 12.1 |
{3}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract image of an eagle with three stripes representing the agency's mission to protect the health of all Americans and provide essential human services.
Public Health Service
்பட 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
K021827 Re:
Trade/Device Name: Accu-Chek Active System Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: NBW: LFR Dated: June 3, 2002 Received: June 4, 2002
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 ' 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 Putman
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
K021827 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.
The Accu-Chek Active system is indicated for 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)
Han
Cooper
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number 6921827
Prescription Use (Per 21 CFR 801.109) OR Over-The-Counter Use i
(Optional Format 1-2-96)
§ 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.