(40 days)
Not Found
No
The 510(k) summary describes a standard in vitro diagnostic reagent system based on an enzymatic reference method (hexokinase) for glucose measurement. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in the device description, intended use, or performance studies. The performance studies focus on traditional analytical metrics like precision and detection limits, not AI/ML-specific metrics.
No
This device is an in vitro diagnostic reagent system used to measure glucose levels for diagnostic purposes, not for direct therapeutic intervention.
Yes
The "Intended Use / Indications for Use" section explicitly states that "Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus and idiopathic hypoglycemia." This indicates the device's diagnostic purpose.
No
The device description clearly states it is an "in vitro diagnostic reagent system" and a "cassette," indicating it is a physical component used on a COBAS INTEGRA system, not a standalone software application.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: Explicitly states "In vitro test for the quantitative determination of glucose in serum, plasma, urine and cerebrospinal fluid (CSF)". This clearly indicates it's used to test samples taken from the body, but performed outside the body.
- Device Description: Describes the cassette as containing an "in vitro diagnostic reagent system".
- Test Principle: Mentions an "enzymatic reference method with hexokinase", which is a common technique used in laboratory diagnostic tests.
All of these points align with the definition of an In Vitro Diagnostic device.
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 the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus and idiopathic hypoglycemia.
Product codes (comma separated list FDA assigned to the subject device)
CFR
Device Description
The cassette COBAS INTEGRA Glucose HK New Formulation 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Precision studies were conducted for serum and plasma, urine application, and CSF application, showing within-run and between-run/day Coefficient of Variation (CV%) for various glucose concentrations.
For serum and plasma, within-run CV% was 1.8% at 4.54 mmol/L and 1.6% at 13.5 mmol/L. Between-run CV% was 2.1% at 4.54 mmol/L and 2.0% at 13.5 mmol/L.
For urine application, within-run CV% was 1.2% at 1.63 mmol/L and 1.1% at 16.3 mmol/L. Between-day CV% was 1.2% at 1.63 mmol/L and 1.1% at 16.3 mmol/L.
For CSF application, within-run CV% was 0.87% at 3.43 mmol/L and 1.3% at 1.72 mmol/L. Between-run CV% was 0.91% at 3.43 mmol/L and 1.4% at 1.72 mmol/L.
The lower detection limit for serum, plasma, urine, and CSF was 0.03 mmol/L.
Exogenous interferences noted: In rare cases, gammopathy, particularly type IgM (Waldenstrom's macroglobulinemia), may cause unreliable results.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Lower detection limit: Serum, plasma, urine and CSF: 0.03 mmol/L
Precision (CV%):
Serum and plasma:
Within run: 1.8% @ 4.54 mmol/L, 1.6% @ 13.5 mmol/L
Between run: 2.1% @ 4.54 mmol/L, 2.0% @ 13.5 mmol/L
Urine application:
Within run: 1.2% @ 1.63 mmol/L, 1.1% @ 16.3 mmol/L
Between day: 1.2% @ 1.63 mmol/L, 1.1% @ 16.3 mmol/L
CSF application:
Within run: 0.87% @ 3.43 mmol/L, 1.3% @ 1.72 mmol/L
Between run: 0.91% @ 3.43 mmol/L, 1.4% @ 1.72 mmol/L
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
SEP ] 1 2006
510(k) Summary -- COBAS INTEGRA Glucose HK Gen. 3
| 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: Theresa (Tracy) Ambrose Bush | |
| Date prepared: | |
| Device Name | Proprietary name: COBAS INTEGRA Glucose HK New Formulation |
| Common name: Gluc2 | |
| Classification name: Glucose Test System | |
| Device Description | The cassette COBAS INTEGRA Glucose HK New Formulation 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 New Formulation test and its predicate device (COBAS INTEGRA Glucose HK Liquid, K972250). |
1
| Feature | Predicate device: Glucose HK
Liquid
(K972250) | Modified device: Glucose HK
New formulation |
|------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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). Glucose measurements
are used in the diagnosis and
treatment of carbohydrate
metabolism disorders including
diabetes mellitus and idiopathic
hypoglycemia. | 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 the diagnosis and treatment
of carbohydrate metabolism
disorders including diabetes
mellitus and idiopathic
hypoglycemia. |
| 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 8ºC | Same |
| Calibrator | Calibrator f.a.s. | Same |
| Quality control | Interval: each lot
Serum and plasma :
Precinorm U and Precinorm U Plus
Precipath U and Precipath U Plus
Urine:
Quantitative urine controls
CSF:
Quantitative CSF controls
Interval: 24 hrs recommended | Same |
| Traceability | Standardized against Isotope | Same |
| Measuring range | 0-40 mmol/L (0-720 mg/dL) | 0-40 mmol/L (0-720 mg/dL) |
| | Extended measuring range with
recommended post dilution factor of | Extended measuring range with
recommended post dilution factor of |
| | 10: 0-400 mmol/L (0-7200 mg/dL) | 10: 0 -400 mmol/L (0-7200
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 |
| Endogenous
interferences | Hemolysis no significant
interferences | Same |
| | Icterus no significant interferences | |
| | Lipemia no significant interferences | |
and the comments of the comments of
2
and the comments of the country
:
:
| Substantial | The table below indicates the similarities between the modified COBAS |
|---|---|
| equivalency - | |
| Differences | INTEGRA Glucose HK New Formulation test and its predicate device |
| (COBAS INTEGRA Glucose HK Liquid, K972250). |
| Feature | Predicate device: Glucose HK
Liquid
(K972250) | Modified device: Glucose HK
New Formulation |
|---------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------|
| Reagent information | | |
| R1 | Mono reagent in vial A and B
(liquid) | R1:
100 mmol/L TRIS, 1.7 mmol/L
ATP, 4 mmol/L Mg++, 1 mmol/L
NADP, pH 7.8 |
| R2 | 100 mmol/L MOPS, 12 mmol/L
ATP, 6 mmol/L NAD+, 10 mmol/L
Mg++, =50 $\mu$ cat/L HK(yeast), =50
$\mu$ cat/L G6PDH (microbial), 0.09%
Sodium azide, pH 7.1 | R2:
4.0 mmol/L Mg++, 30 mmol/L
HEPES, =130 $\mu$ cat/L HK (yeast),
=250 $\mu$ cat/L G6PDH (microbial),
pH 7.0 |
3
| Precision | Serum and plasma: | Serum and plasma : |
|---|---|---|
| Within run: | Within run CV%: | |
| 1.7% @ 5.3 mmol/L | 1.8% @ 4.54 mmol/L | |
| 0.72% @ 33.2 mmol/L | 1.6% @ 13.5 mmol/L | |
| Between run: | Between run: | |
| 2.6% @ 5.3 mmol/L | 2.1% @ 4.54 mmol/L | |
| 1.5% @ 33.2 mmol/L | 2.0% @ 13.5 mmol/L | |
| Urine application | Urine application | |
| Within run: | Within run: | |
| 1.7% @ 1.7 mmol/L | 1.2% @ 1.63 mmol/L | |
| 1.8% @ 37.1 mmol/L | 1.1% @ 16.3 mmol/L | |
| Between run: | Between day: | |
| 4.3% @ 1.7 mmol/L | 1.2% @ 1.63 mmol/L | |
| 2.9% @ 37.1 mmol/L | 1.1% @ 16.3 mmol/L | |
| CSF application | CSF application | |
| Within run: | Within run: | |
| 1.6% @ 1.7 mmol/L | 0.87% @ 3.43 mmol/L | |
| 1.8% @ 3.3 mmol/L | 1.3% @ 1.72 mmol/L | |
| Between run: | Between run: | |
| 2.3% @ 1.7 mmol/L | 0.91% @ 3.43 mmol/L | |
| 1.9% @ 3.3 mmol/L | 1.4% @ 1.72 mmol/L | |
| Lower detection | ||
| limit | Serum and plasma: | |
| 0.033 mmol/L | Serum, plasma, urine and CSF: | |
| 0.03 mmol/L | ||
| Urine application: | ||
| 0.22 mmol/L | ||
| CSF application: | ||
| 0.023 mmol/L | ||
| Exogenous | ||
| Interferences | Falsely low results may be caused | |
| by elevated pyruvates levels | In rare cases gammopathy, in | |
| particular type IgM | ||
| (Waldenstrom's | ||
| macroglobulinemia) may cause | ||
| unreliable results. | ||
| Gammopathy, in particular IgM, | ||
| may cause unreliable results in rare | ||
| cases | ||
and the state of the states of the states
:
:
.
.
:
4
| 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 assay, resulting in the
Glucose HK New Formulation assay, did not affect the intended use or
indications for use of the device as described in the labeling, nor did 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) 521-3723
• FAX: (317) 521-2324
• email: tracy.bush@roche.com |
5
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three wing-like shapes, symbolizing health and human services. The eagle is positioned to the right of a circular text element that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES . USA".
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
SEP 1 1 2006
Ms. Theresa Abrose Bush Roche Diagnostics 9115 Hague Rd. Indianapolis, IN 46250
ﺮ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟ
Re: K062239 Trade/Device Name: Glucose HK New Formulation (Gluc2) Regulation Number: 21 CFR 862.1345 Regulation Name: Glucose test system Regulatory Class: Class II Product Code: CFR Dated: August 1, 2006 Received: August 2, 2006
Dear Ms. Abrose Bush:
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).
6
Page 2 -
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 Gutt
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
7
510(k) Number (if known):
Device Name: Glucose HK New Formulation (Gluc2)
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 the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus and idiopathic hypoglycemia.
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)
Albuts Siz
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
KOL 2239 510(k)________________________________________________________________________________________________________________________________________________________________________