(157 days)
Not Found
No
The summary describes a data management system for blood glucose monitoring, focusing on automation of record keeping and data transfer. There is no mention of AI, ML, or any related technologies like image processing or complex algorithms for analysis or prediction. The device's function is explicitly stated as not providing diagnosis.
No
The description states the device is a "data management unit" that helps with "record keeping" and "automating the record keeping associated with blood glucose and quality control tests." It explicitly says, "This device is not intended to provide any diagnosis on patient results." A therapeutic device is used for treatment or prevention of diseases, which this device does not do.
No
The device description explicitly states, "This device is not intended to provide any diagnosis on patient results." Its primary function is automated record-keeping and data management for blood glucose and quality control tests.
No
The device description explicitly states it is a "bedside data management unit" and a "bedside unit," implying a physical hardware component beyond just software. It collects, stores, transfers information, and generates reports, which are functions typically performed by a hardware device running software.
Based on the provided information, the Accu-Chek HQ system is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the system is for measurement of glucose on an Accu-Chek monitor and automating record keeping. It does not state that the system itself performs the diagnostic test or provides a diagnostic result.
- Device Description: The description emphasizes that the system is a data management unit that collects, stores, transfers, and reports information. It explicitly states: "This device is not intended to provide any diagnosis on patient results."
- Role of the Healthcare Provider: The description highlights that the healthcare provider visually confirms the results on the Accu-Chek HQ display against the monitor display, indicating that the diagnostic result is obtained from the monitor, not the HQ system.
- Predicate Device: The predicate device, the AccuData Glucose Test Station, also appears to be a data management system for glucose testing, further supporting the idea that the Accu-Chek HQ is not the diagnostic device itself.
The Accu-Chek HQ system acts as a data management and quality assurance tool for glucose testing performed by a separate Accu-Chek monitor (which would be the IVD).
N/A
Intended Use / 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.
Product codes
LFR
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
health care professionals, bedside unit
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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. |
Continued on next page
1
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
2
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 conjunction
with Accu-Chek blood
glucose monitors | Yes | Yes |
| Intended use | The Accu-Chek HQ system is a
bedside unit that can help you
provide quality patient care by
measurement of glucose on the Accu-
Chek monitor, and by automating the
record keeping associated with blood
glucose and quality control tests. | The AccuData GTS is a
bedside unit that can help you
provide quality patient care by
automating the record keeping
associated with blood glucose
and quality control tests. |
| Affect on blood glucose
monitors' performance
specifications | None | None |
| Affect on blood glucose test
procedure (e.g., test strip
insertion and dosing
techniques) | None | None |
| Records | Time and date, operator ID, patient
ID, proficiency sample ID, control
solution information, test strip
information, test results and comment
codes. | Same |
| Connect directly to a printer to
generate reports such as
Levey-Jennings | Yes | Yes |
| Transfer information to
another system for hospital-
wide record keeping and data
analysis | Yes | Yes |
: 1
3
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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Page 2
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
5
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.
(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
ﺎﺕ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤ Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
019