ACCU-CHEK HQ SYSTEM

K983047 · Boehringer Mannheim Corp. · LFR · Feb 5, 1999 · Clinical Chemistry

Device Facts

• Record ID: K983047
• Device Name: ACCU-CHEK HQ SYSTEM
• Applicant: Boehringer Mannheim Corp.
• Product Code: LFR · Clinical Chemistry
• Decision Date: Feb 5, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1345
• Device Class: Class 2
• Attributes: Software as a Medical Device

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.

Device Story

Accu-Chek HQ system is a bedside data management unit; automates record keeping for blood glucose and quality control tests. Collects, stores, and transfers data including time/date, operator ID, patient ID, proficiency sample ID, control solution info, test strip info, test results, and comment codes. Used by health care professionals in clinical settings. Connects to Accu-Chek monitors to receive data; provides output via display and printer (e.g., Levey-Jennings reports); supports data transfer to hospital-wide systems. Does not provide diagnostic results; health care providers verify displayed results against monitor display to ensure data integrity. Benefits include improved quality assurance and streamlined clinical documentation.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Bedside data management unit; connects to Accu-Chek blood glucose monitors. Features include data storage, report generation (e.g., Levey-Jennings), and connectivity to printers and hospital information systems. Does not affect monitor performance or test procedures.

Indications for Use

Indicated for use by health care professionals in a clinical setting to assist in the management of blood glucose and quality control test records when used in conjunction with an Accu-Chek blood glucose monitor.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• AccuData Glucose Test Station (K924475)

Submission Summary (Full Text)

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

Continued on next page

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# 510(k) Summary, Continued

4) 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.

5) 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<br>(new device) | AccuData GTS<br>(predicate device) |
|-----------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Used solely in conjunction<br>with Accu-Chek blood<br>glucose monitors | Yes | Yes |
| Intended use | The Accu-Chek HQ system is a<br>bedside unit that can help you<br>provide quality patient care by<br>measurement of glucose on the Accu-<br>Chek monitor, and by automating the<br>record keeping associated with blood<br>glucose and quality control tests. | The AccuData GTS is a<br>bedside unit that can help you<br>provide quality patient care by<br>automating the record keeping<br>associated with blood glucose<br>and quality control tests. |
| Affect on blood glucose<br>monitors' performance<br>specifications | None | None |
| Affect on blood glucose test<br>procedure (e.g., test strip<br>insertion and dosing<br>techniques) | None | None |
| Records | Time and date, operator ID, patient<br>ID, proficiency sample ID, control<br>solution information, test strip<br>information, test results and comment<br>codes. | Same |
| Connect directly to a printer to<br>generate reports such as<br>Levey-Jennings | Yes | Yes |
| Transfer information to<br>another system for hospital-<br>wide record keeping and data<br>analysis | 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 [phone].

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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone], 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:

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.

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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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OR

Over-The-Counter Use

(Optional Format 1-2-96)

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