(30 days)
No
The summary describes a standard in vitro diagnostic reagent system for glucose measurement using an enzymatic method. There is no mention of AI or ML in the intended use, device description, or performance studies.
No.
The device is an in vitro diagnostic reagent system for measuring glucose levels, which is used in diagnosis but not for direct treatment or therapy.
Yes
The device is described as an "in vitro diagnostic reagent system" used to determine glucose levels, which are then used in the "diagnosis and treatment of carbohydrate metabolism disorders."
No
The device description clearly states it is an "in vitro diagnostic reagent system" and a "cassette" intended for use on a hardware system (COBAS INTEGRA SYSTEMS). This indicates it is a physical reagent and not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states it is an "In vitro test for the quantitative determination of glucose in serum, plasma, urine and cerebrospinal fluid (CSF)". This clearly indicates it is used to test samples taken from the body (in vitro) to diagnose or monitor a condition.
- Device Description: The "Device Description" further confirms this by stating it "contains an in vitro diagnostic reagent system intended for use on COBAS INTEGRA SYSTEMS for the quantitative determination of glucose in serum, plasma, urine, and cerebrospinal fluid (CSF)."
- Purpose: The intended use also mentions its purpose in the "diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and pancreatic islet cell tumors." This aligns with the definition of an IVD, which is used to provide information for diagnosis, monitoring, or treatment.
Therefore, based on the provided information, the device is an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
In vitro test for the quantitative determination of glucose in serum, plasma, urine and cerebrospinal fluid (CSF) on COBAS INTEGRA systems.
Glucose measurements are used in diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and pancreatic islet cell tumors.
Product codes
CFR
Device Description
The cassette COBAS INTEGRA Glucose HK Gen. 3 contains an in vitro diagnostic reagent system intended for use on COBAS INTEGRA SYSTEMS for the quantitative determination of glucose in serum, plasma, urine, and cerebrospinal fluid (CSF).
The test principle is an enzymatic reference method with hexokinase.
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
Not Found
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
The document describes performance characteristics for precision, linearity, lower detection limit, and interferences:
Precision:
Serum and plasma:
Within run CV%:
0.41% @ 4.48 mmol/L
0.47% @ 12.48 mmol/L
Between day:
1.09% @ 4.44 mmol/L
0.90% @ 12.46 mmol/L
Urine application
Within run:
1.35% @ 0.83 mmol/L
0.64% @ 2.42 mmol/L
Between day:
0.75% @ 0.84 mmol/L
0.83% @ 2.43 mmol/L
CSF application
Within run:
1.13% @ 3.20 mmol/L
1.49% @ 9.31 mmol/L
Linearity:
0.12-40 mmol/L (before dilution)
Lower detection limit:
Serum, plasma, urine and CSF: 0.12 mmol/L
Endogenous interferences:
Hemolysis: up to 1200 H Index
Icterus: up to 60 I Index
Lipemia: up to 1900 L Index
Exogenous Interferences:
Tetracyclin at therapeutic concentration gives falsely low results in urine samples
Gammopathy, in particular IgM, may cause unreliable results in rare cases
Key Metrics
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.
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510(k) Summary – COBAS INTEGRA Glucose HK Gen. 3
です。 で
| 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 | |
|----------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter
name, address,
contact | Roche Diagnostics
9115 Hague Rd
Indianapolis IN 46250
(317) 521-3723 | |
| | Contact person: Corina Harper | |
| | Date prepared: April 11, 2006 | |
| | Device Name | Proprietary name: COBAS INTEGRA Glucose HK Gen. 3 test |
| Common name: Glucose HK Gen. 3 | | |
| Classification name: Glucose Test System | | |
| Device
Description | The cassette COBAS INTEGRA Glucose HK Gen. 3 contains an in vitro
diagnostic reagent system intended for use on COBAS INTEGRA SYSTEMS
for the quantitative determination of glucose in serum, plasma, urine, and
cerebrospinal fluid (CSF). | |
| | The test principle is an enzymatic reference method with hexokinase. | |
| Intended use | In vitro test for the quantitative determination of glucose in serum, plasma,
urine and cerebrospinal fluid (CSF) on COBAS INTEGRA systems. | |
| Predicate
Device | We claim substantial equivalence to the COBAS INTEGRA Glucose HK
Liquid cleared as K972250. | |
| Substantial
equivalency -
Similarities | The table below indicates the similarities between the modified COBAS
INTEGRA Glucose HK Gen. 3 test and its predicate device (COBAS
INTEGRA Glucose HK Liquid, K972250). | |
| Feature | Predicate device: Glucose HK
Liquid
(K972250) | Modified device: Glucose HK
Gen. 3 |
| General | | |
| Intended Use/
Indications for
Use | The cassette COBAS INTEGRA
Glucose HK Liquid contains an in
vitro diagnostic reagent system
intended for use on COBAS
INTEGRA systems for the
quantitative determination of
glucose concentration in serum,
plasma, urine and cerebrospinal
fluid (CSF). | In vitro test for the quantitative
determination of glucose in serum,
plasma, urine and cerebrospinal
fluid (CSF) on COBAS INTEGRA
systems |
| Specimen type | Serum, plasma, urine, CSF | Same |
| Test principle | | |
| Reference
method | Enzymatic reference method with
hexokinase. | Same |
| Reagent information | | |
| Stability - shelf
life and on-board | 2-8 °C until expiration date
COBAS INTEGRA 400
8 weeks at 10 to 15° C
COBAS INTEGRA 700/800
8 weeks at 8°C | Same |
| Calibrator | Calibrator f.a.s.
Interval: each lot | Same |
| Quality control | Serum and plasma:
Precinom U and Precinorm U Plus
Precipath and Precipath U Plus
Urine:
Quantitative urine controls
CSF:
Quantitative CSF controls
Interval: 24 hrs recommended | Same |
| Traceability | Standardized against Isotope
Dilution Mass Spectrometry | Same |
| Performance characteristics | | |
| Measuring range | 0-40 mmol/L (0-720 mg/dL)
Extended measuring range with
recommended post dilution factor of
10: 0-400 mmol/L (0-7200 mg/dL) | 0.12-40 mmol/L (0.12-720 mg/dL)
Extended measuring range with
recommended post dilution factor
of 10: 0.12-400 mmol/L (2.16-7200
mg/dL) |
| Expected values
(literature
reference)
Additional values
are referenced in
the method sheet | Plasma (fasting): 3.88-6.38 mmol/L
Urine:
1st morning urine 0.3-1.1 mmol/L
24 h urine 0.11-0.50 mmol/24h
Serum/plasma:
Adults 4.11-5.89 mmol/L | Plasma (fasting): 3.88-6.38 mmol/L
Urine:
1st morning urine 0.3-1.1 mmol/L
24 h urine 0.3-0.96 mmol/L
Same |
: : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : :
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| Substantial | The table below indicates the similarities between the modified COBAS |
|---|---|
| equivalency - | INTEGRA Glucose HK Gen. 3 test and its predicate device (COBAS |
| Differences | INTEGRA Glucose HK Liquid, K972250). |
·
:
| Feature | Predicate device: Glucose HK
Liquid
(K972250) | Modified device: Glucose HK
Gen.3 |
|----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|
| Reagent information | | |
| R1 | Mono reagent in vial A and B
(liquid) | R1:
5.0 mmol/L MES, ≥4.5 mmol/L
ATP, 24 mmol/L Mg++, ≥7.0
mmol/L NADP, pH 6.0 |
| R2 | 100 mmol/L MOPS, 12 mmol/L
ATP, 6 mmol/L NAD+, 10 mmol/L Mg++, ≥50 µcat/L HK(yeast), ≥50
µcat/L G6PDH (microbial), 0.09%
Sodium azide, pH 7.1 | R2:
4.0 mmol/L Mg++, 200 mmol/L
HEPES, ≥300 µcat/L HK (yeast),
≥300 µcat/L G6PDH (microbial),
pH 8.0 |
| Performance characteristics | | |
| Precision | Serum and plasma:
Within run:
1.7% @ 5.3 mmol/L
0.72% @ 33.2 mmol/L
Between run:
2.6% @ 5.3 mmol/L
1.5% @ 33.2 mmol/L | Serum and plasma:
Within run CV%:
0.41% @ 4.48 mmol/L
0.47% @ 12.48 mmol/L
Between day:
1.09% @ 4.44 mmol/L
0.90% @ 12.46 mmol/L |
| | Urine application
Within run:
1.7% @ 1.7 mmol/L
1.8% @ 37.1 mmol/L
Between run:
4.3% @ 1.7 mmol/L
2.9% @ 37.1 mmol/L | Urine application
Within run:
1.35% @ 0.83 mmol/L
0.64% @ 2.42 mmol/L
Between day:
0.75% @ 0.84 mmol/L
0.83% @ 2.43 mmol/L |
| | CSF application
Within run:
1.6% @ 1.7 mmol/L
1.8% @ 3.3 mmol/L
Between run:
2.3% @ 1.7 mmol/L
1.9% @ 3.3 mmol/L | CSF application
Within run:
1.13% @ 3.20 mmol/L
1.49% @ 9.31 mmol/L |
| Linearity | 0-40 mmol/L
(before dilution) | 0.12-40 mmol/L
(before dilution) |
| Lower detection
limit | Serum and plasma:
0.033 mmol/L
Urine application:
0.22 mmol/L
CSF application:
0.023 mmol/L | Serum, plasma, urine and CSF:
0.12 mmol/L |
| Endogenous
interferences | Hemolysis no significant
interferences
Icterus no significant interferences | Hemolysis: up to 1200 H Index
Icterus: up to 60 I Index |
| | Lipemia no significant interferences | Lipemia: up to 1900 L Index |
| Exogenous
Interferences | Falsely low results may be caused
by elevated pyruvates levels | Tetracyclin at therapeutic
concentration gives falsely low
results in urine samples |
| | Gammopathy, in particular IgM,
may cause unreliable results in rare
cases | Same |
| Proposed
Labeling | Proposed labeling sufficient to describe the device, its intended use, and the
directions for use can be found in Section V. We believe the proposed version
of the device labeling presented contains all of the technical information
required per 21 CFR 809.10. | |
| Validation and
Design Control | Development activities were conducted under appropriate design control
procedures and the overall product specifications were met. The Declaration
of Conformity with Design Controls and Results of Risk Analysis are
provided in Section 5.1. Analytical Performance. | |
| Confidentiality | Roche Diagnostics Corporation requests that the FDA not disclose the nature
or existence of this submission until the substantial equivalence decision has
been reached. | |
| Closing | Modification of the COBAS INTEGRA Glucose HK Gen.3 does not affect
the intended use or indications for use of the device as described in the
labeling, nor does it alter the fundamental scientific technology of the device.
Therefore, we trust the information provided in this Special 510(k) will
support a decision of substantial equivalence of the COBAS INTEGRA
Glucose HK Gen.3 to the predicate.
If you have any questions or require further information, please do not
hesitate to contact this office.
• Phone: (317) 521-3831
• FAX: (317) 521-2324
• email: corina.harper@roche.com | |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/5/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" arranged around the perimeter. Inside the circle is a stylized emblem featuring an abstract design that resembles an eagle or a bird in flight.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
MAY 17 2006
Ms. Corina Harper Regulatory Affairs Consultant Roche Diagnostics 9115 Hague Road PO Box 50416 Indianapolis, IN 46250-0416
K061048 Re: Trade/Device Name: COBAS INTEGRA Glucose HK Gen 3 Regulation Number: 21 CFR$ 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: CFR Dated: April 14, 2006 Received: April 17, 2006
Dear Ms. Harper:
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 Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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This letter will allow you to begin marketing your device as described in your Section 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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0484. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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/industry/support/index.html.
Sincerely yours,
Alberto Setti, Ph.D.
Alberto Gutierrez, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known):
61048
Device Name: COBAS INTEGRA Glucose HK Gen 3
Indications For Use:
In vitro test for the quantitative determination of glucose in serum, plasma, urine and cerebrospinal fluid (CSF) on COBAS INTEGRA systems.
Glucose measurements are used in diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and pancreatic islet cell tumors.
Prescription Use XXXX (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
CLL
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safe
s106(k) K661048