The Accu-Chek HQ system is a bedside unit that can help health care professionals provide quality patient care by measurement of glucose on an Accu-Chek monitor, and by automating the record keeping associated with blood glucose and quality control tests.

Device Description

The Accu-Chek HO system is a bedside data management unit that helps provide quality patient care by automating the record keeping associated with blood glucose and quality control tests. The Accu-Chek HQ system collects, stores, transfers information, and generates reports about the monitor, test strips, control solutions, patient results and operator performance for quality assurance.

This device is not intended to provide any diagnosis on patient results. The health care provider has the ability to visually confirm that the results on the Accu-Chek HQ display match the results on the monitor display. This inherent redundancy provides a method for the health care provider to confirm all data that is being logged by the Accu-Chek HQ system.

AI/ML Overview

The provided text describes a 510(k) summary for the Accu-Chek HQ System, a data management unit for blood glucose and quality control tests. However, the document does not contain acceptance criteria or a study that proves the device meets specific acceptance criteria.

Instead, the document focuses on:

Device Description: What the Accu-Chek HQ System is and what it does (collects, stores, transfers information, generates reports).
Intended Use: How the device is meant to be used (automating record-keeping associated with blood glucose and quality control tests, in conjunction with an Accu-Chek monitor).
Comparison to a Predicate Device: A table comparing the Accu-Chek HQ System to the AccuData Glucose Test Station, highlighting similarities and differences in functionality and intended use.
Regulatory Information: The FDA's review and determination of substantial equivalence (K983047).

Crucially, the document explicitly states: "This device is not intended to provide any diagnosis on patient results." and "The health care provider has the ability to visually confirm that the results on the Accu-Chek HQ display match the results on the monitor display. This inherent redundancy provides a method for the health care provider to confirm all data that is being logged by the Accu-Chek HQ system." This indicates that the device's primary function is data management and record-keeping, and its performance is not evaluated in terms of diagnostic accuracy or clinical outcomes.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study that proves the device meets them because this information is not present in the provided text. The document describes a "data processing module for clinical use" where the "performance" is more about data accuracy and transfer, rather than a clinical diagnostic performance that would typically have specific sensitivity/specificity, accuracy, etc. acceptance criteria and a corresponding study.

Summary

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FEB 5 1999

11.000

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	Boehringer Mannheim Corporation “doing business as Roche Diagnostics” 9115 Hague Rd. Indianapolis, IN 46250 (800) 428-5074 ext. 3830 Contact Person: Mike Flis Date Prepared: August 28, 1998
2) Device name	Proprietary name: Accu-Chek HQ System Common name: Data processing module for clinical use Classification name: Glucose test system
3) Predicate device	AccuData Glucose Test Station, FDA Control #K924475.

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510(k) Summary, Continued

Device The Accu-Chek HO system is a bedside data management unit that helps Description provide quality patient care by automating the record keeping associated with blood glucose and quality control tests. The Accu-Chek HQ system collects, stores, transfers information, and generates reports about the monitor, test strips, control solutions, patient results and operator performance for quality assurance.

This device is not intended to provide any diagnosis on patient results. The health care provider has the ability to visually confirm that the results on the Accu-Chek HQ display match the results on the monitor display. This inherent redundancy provides a method for the health care provider to confirm all data that is being logged by the Accu-Chek HQ system.

Intended use The Accu-Chek HQ system is a bedside unit that can help health care professionals provide quality patient care by measurement of glucose on an Accu-Chek monitor, and by automating the record keeping associated with blood glucose and quality control tests.

Continued on next page

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510(k) Summary, Continued

The Accu-Chek HQ System is substantially equivalent to other products in 6) Comparison to predicate commercial distribution intended for similar use. Most notably it is device substantially equivalent to the Roche Diagnostics AccuData Glucose Test Station (GTS), FDA Control #K924475. The following table summarizes the similarities and difference between the new device and the predicate device.

Topic	Accu-Chek HQ(new device)	AccuData GTS(predicate device)
Used solely in conjunctionwith Accu-Chek bloodglucose monitors	Yes	Yes
Intended use	The Accu-Chek HQ system is abedside unit that can help youprovide quality patient care bymeasurement of glucose on the Accu-Chek monitor, and by automating therecord keeping associated with bloodglucose and quality control tests.	The AccuData GTS is abedside unit that can help youprovide quality patient care byautomating the record keepingassociated with blood glucoseand quality control tests.
Affect on blood glucosemonitors' performancespecifications	None	None
Affect on blood glucose testprocedure (e.g., test stripinsertion and dosingtechniques)	None	None
Records	Time and date, operator ID, patientID, proficiency sample ID, controlsolution information, test stripinformation, test results and commentcodes.	Same
Connect directly to a printer togenerate reports such asLevey-Jennings	Yes	Yes
Transfer information toanother system for hospital-wide record keeping and dataanalysis	Yes	Yes

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Image /page/3/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" in bold, uppercase letters. The text is centered and appears to be part of a document or header. The font is a serif typeface, and the overall impression is formal and official.

Public Health Service

FEB 5 1999

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Mr. Mike Flis Regulatory Affairs Specialist Boehringer Mannheim Corporation 9115 Hague Road Indianapolis, Indiana 46250

Re: K983047 Trade Name: Accu-Chek HQ System Regulatory Class: II Product Code: LFR Dated: December 14, 1998 Received: December 15, 1998

Dear Mr. Flis:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.

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"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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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K983047 510(k) Number (if known): Device Name: Accu-Chek HQ System Indications for Use:

(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 K983047
Cop

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Over-The-Counter Use

(Optional Format 1-2-96)

019

Regulation Number and Section

§ 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.