(28 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, and calf
Instrument Operating Principle -- photometry
Reagent Test Principle -- glucose dehydrogenase
Here's a breakdown of the acceptance criteria and study information for the Accu-Chek Active System (K021448):
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly stated as numerical targets for accuracy (e.g., % within a certain range). Instead, the study aims to demonstrate "good correlation (r > 0.90)" between results from different Alternative Site Testing (AST) locations and finger results.
| Metric | Acceptance Criteria (Implied) | Reported Device Performance (Upper Arm) | Reported Device Performance (Thigh) | Reported Device Performance (Calf) |
|---|---|---|---|---|
| Correlation (r) | > 0.90 | 0.984 | 0.983 | 0.982 |
2. Sample Size Used for the Test Set and Data Provenance
| AST Location | Sample Size (N) | Data Provenance |
|---|---|---|
| Upper Arm | 65 | Conducted at the manufacturing facility (likely US/Europe) |
| Thigh | 62 | Conducted at the manufacturing facility (likely US/Europe) |
| Calf | 64 | Conducted at the manufacturing facility (likely US/Europe) |
The data is prospective as it was generated from a study specifically conducted to demonstrate the device's performance with additional AST sites.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the given document. The study compares AST results to "finger results," which is implicitly considered the reference measure. It doesn't mention a separate expert review process for the glucose readings themselves.
4. Adjudication Method for the Test Set
This information is not provided in the given document. Since the study compares the device's readings from different sites to readings from a fingerstick (likely the same device's reading from a fingerstick or a laboratory reference), a traditional adjudication method for subjective medical imaging interpretation wouldn't apply here.
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. This type of study focuses on human reader performance, often in conjunction with AI. The provided study is a device performance study, not one evaluating human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, a standalone study was done. The study assesses the accuracy of the Accu-Chek Active System when using blood samples from various alternative sites. It evaluates the device's performance independently, without human interpretation as a primary factor in the measured outcome. The device itself is the "algorithm" in this context (photometric measurement).
7. The Type of Ground Truth Used
The ground truth used is fingerstick blood glucose readings. The study implicitly uses finger results (from the same device or a similar, validated method) as the reference standard to which the Alternative Site Test (AST) results are compared. The phrase "AST location versus Finger" directly indicates this comparison.
8. The Sample Size for the Training Set
The document does not provide information on the sample size for a training set. This is a device performance study, not specifically an AI/machine learning model where a training set distinct from a test set would typically be described. The "study" mentioned likely refers to the overall validation of the modified device rather than the training of a computational algorithm.
9. How the Ground Truth for the Training Set Was Established
Since there is no mention of a separate training set or an AI/machine learning model being developed, this information is not applicable/provided in the document. The device's underlying technology (photometry and glucose dehydrogenase chemical reaction) is well-established, and its "training" would have occurred during the initial development and validation of the predicate device (K012324), not detailed here.
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JUN 0 3 2002
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: May 2, 2002 |
| 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). |
| 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. |
| Continued on next page |
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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 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, andupper arm | Finger and forearm |
Continued on next page
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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
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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.
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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
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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)
§ 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.