(101 days)
No
The summary describes a standard enzymatic assay for glucose measurement and does not mention any AI or ML components. The performance studies are based on traditional analytical methods.
No
This device is an in vitro diagnostic reagent system used to measure glucose levels, which aids in the diagnosis and treatment of metabolic disorders but does not directly treat a disease or condition in a patient.
Yes
The "Intended Use / Indications for Use" section explicitly states that "Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders". This indicates that the device is used for diagnostic purposes.
No
The device description explicitly states it is a "cassette COBAS INTEGRA Glucose HK Gen. 3" containing an "in vitro diagnostic reagent system," indicating it is a physical component with reagents, not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The document explicitly states the intended use is an "In vitro test for the quantitative determination of glucose in serum, plasma, urine and cerebrospinal fluid (CSF)." This clearly indicates the test is performed outside of the body using biological samples.
- Device Description: The description refers to the device as an "in vitro diagnostic reagent system."
- Purpose: The purpose of the test is for "diagnosis and treatment of carbohydrate metabolism disorders," which is a diagnostic application.
The document consistently uses terminology and describes activities that 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).
Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Substantial equivalence was demonstrated by comparing the modified COBAS INTEGRA Glucose HK Gen. 3 test to its predicate device, COBAS INTEGRA Glucose HK Gen. 3 Assay (K061048), across various features including Intended Use, Assay Protocol, Sample Type, Calibrator, Calibration Frequency, Controls, Reagent Stability, Measuring Range, Precision, Analytical Sensitivity, Limitations due to Interference, and Expected Values.
Precision - Serum/Plasma (Regular Application)
- Repeatability (Within-Run Precision)
- HS1: Mean = 64.3 mg/dL, CV = 0.69%
- HS2: Mean = 120 mg/dL, CV = 0.78%
- HS3: Mean = 665 mg/dL, CV = 0.70%
- PNU: Mean = 90.8 mg/dL, CV = 0.58%
- PPU: Mean = 247 mg/dL, CV = 0.59%
- Intermediate (Between Run Precision)
- HS1: Mean = 64.3 mg/dL, CV = 1.26%
- HS2: Mean = 120 mg/dL, CV = 1.41%
- HS3: Mean = 665 mg/dL, CV = 1.32%
- PNU: Mean = 90.8 mg/dL, CV = 1.24%
- PPU: Mean = 247 mg/dL, CV = 1.21%
Precision - Serum/Plasma (Stat Application)
- Repeatability (Within-Run Precision)
- HS1: Mean = 64.7 mg/dL, CV = 0.61%
- HS2: Mean = 121 mg/dL, CV = 0.69%
- HS3: Mean = 487 mg/dL, CV = 0.74%
- PNU: Mean = 91.4 mg/dL, CV = 0.58%
- PPU: Mean = 249 mg/dL, CV = 0.57%
- Intermediate (Between Run Precision)
- HS1: Mean = 64.7 mg/dL, CV = 1.08%
- HS2: Mean = 121 mg/dL, CV = 1.40%
- HS3: Mean = 487 mg/dL, CV = 1.10%
- PNU: Mean = 91.4 mg/dL, CV = 1.15%
- PPU: Mean = 249 mg/dL, CV = 1.07%
Precision - Urine (Regular Application)
- Repeatability (Within-Run Precision)
- HS1: Mean = 8.65 mg/dL, CV = 2.28%
- HS2: Mean = 17.3 mg/dL, CV = 1.05%
- HS3: Mean = 672 mg/dL, CV = 0.53%
- PNU: Mean = 90.8 mg/dL, CV = 0.58%
- PPU: Mean = 247 mg/dL, CV = 0.59%
- Intermediate (Between Run Precision)
- HS1: Mean = 8.65 mg/dL, CV = 2.83%
- HS2: Mean = 17.3 mg/dL, CV = 1.37%
- HS3: Mean = 672 mg/dL, CV = 1.01%
- PNU: Mean = 90.8 mg/dL, CV = 1.24%
- PPU: Mean = 247 mg/dL, CV = 1.21%
Precision - Urine (Stat Application)
- Repeatability (Within-Run Precision)
- HS1: Mean = 8.58 mg/dL, CV = 2.71%
- HS2: Mean = 17.4 mg/dL, CV = 1.16%
- HS3: Mean = 476 mg/dL, CV = 0.64%
- PNU: Mean = 91.4 mg/dL, CV = 0.58%
- PPU: Mean = 249 mg/dL, CV = 0.57%
- Intermediate (Between Run Precision)
- HS1: Mean = 8.58 mg/dL, CV = 3.20%
- HS2: Mean = 17.4 mg/dL, CV = 1.65%
- HS3: Mean = 476 mg/dL, CV = 1.09%
- PNU: Mean = 91.4 mg/dL, CV = 1.15%
- PPU: Mean = 249 mg/dL, CV = 1.07%
Precision - CSF (Regular Application)
- Repeatability (Within-Run Precision)
- Level I: Mean = 57.7 mg/dL, CV = 1.13%
- Level II: Mean = 168 mg/dL, CV = 1.49%
Precision - CSF (Stat Application)
- Repeatability (Within-Run Precision)
- CSF 1: Mean = 39.6 mg/dL, CV = 0.63%
- CSF 2: Mean = 283 mg/dL, CV = 0.39%
- CSF 3: Mean = 517 mg/dL, CV = 0.51%
- PNU Plus: Mean = 92.4 mg/dL, CV = 0.53%
- PPU Plus: Mean = 240 mg/dL, CV = 0.43%
Analytical Sensitivity
- Lower Limits of Measurement: Limit of Blank = 2.16 mg/dL, Limit of Detection = 4.32 mg/dL
Method Comparison - Serum
- Study Type: Comparison of regular application vs. Stat application on COBAS INTEGRA 800 analyzer with COBAS INTEGRA Glucose HK Gen. 3 reagent.
- Sample Size: n=79
- Results (Passing Bablok): y = 0.997x + 0.033 mmol/L, tau = 0.999, SD (md 95) = 0.067
- Predicate Device Comparison (Linear Regression): y = 0.997x + 0.032 mmol/L, r = 1.00, Sy.x = 0.032
Method Comparison - Urine
- Study Type: Comparison of regular application vs. Stat application on COBAS INTEGRA 800 analyzer with COBAS INTEGRA Glucose HK Gen. 3 reagent.
- Sample Size: n=50
- Results (Passing Bablok): y = 1.00x + 0.002 mmol/L, tau = 0.996, SD (md 95) = 0.082
- Predicate Device Comparison (Linear Regression): y = 1.00x + 0.003 mmol/L, r = 1.00, Sy,x = 0.041
Limitations - Interference
- Icterus: No significant interference up to an I index of 60 (approximate concentration of conjugated and unconjugated bilirubin: 60 mg/dL or 1026 umol/L).
- Hemolysis: No significant interference up to an H index of 1200 (approximate hemoglobin concentration: 1200 mg/dL or 744 umol/L).
- Lipemia: No significant interference up to an L index of 1900. Poor correlation between L index (turbidity) and triglyceride concentration.
- Other: In very rare cases, gammopathy, particularly type IgM (Waldenstrom's macroglobulinemia), may cause unreliable results.
- Drugs: No interference found at therapeutic concentrations using common drug panels.
- (*measured at glucose concentrations of approximately 63.07 mg/dL and 297.33 mg/dL).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Lower Limits of Measurement:
Limit of Blank = 2.16 mg/dL
Limit of Detection = 4.32 mg/dL
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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Glucose HK Gen. 3 Stat Assay
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・・
:
| 510(k) Summary | 1092603 |
|---|---|
| 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 Road | |
| Indianapolis, IN 46250 | |
| (317) 521 - 3831 | |
| Contact Person: Kathie J. Goodwin | |
| Date Prepared: August 24th, 2009 | |
| Device Name | Proprietary names: COBAS INTEGRA Glucose HK Gen. 3 Assay |
| Common names: Glucose HK Gen. 3 | |
| Classification names: Glucose Test System | |
| Regulation Number: 21 CFR 862.1345 | |
| 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. | |
| Intended use | In vitro test for the quantitative determination of glucose in serum, plasma, |
| urine and cerebrospinal fluid (CSF). | |
| Indications for | |
| Use | Glucose measurements are used in the diagnosis and treatment of |
| carbohydrate metabolism disorders including diabetes mellitus, neonatal | |
| hypoglycemia, idiopathic hypoglycemia and pancreatic islet cell tumors. |
:
1
Substantial equivalence The table below indicates the similarities between the modified COBAS INTEGRA Glucose HK Gen. 3 test and its predicate device COBAS INTEGRA Glucose HK Gen. 3, K061048.
Substantial equivalence -
comparison
| Feature | COBAS INTEGRA Glucose Gen. 3
Assay
Serum/Plasma Application | Predicate Device: COBAS
INTEGRA Glucose Gen. 3 Assay
Serum/Plasma Application
(K061048) |
|--------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------|
| Intended Use | In vitro test for the quantitative
determination of glucose in serum,
plasma, urine, and cerebrospinal fluid
(CSF) on COBAS INTEGRA
systems. | Same |
| Assay Protocol | Enzymatic reference method with
Hexokinase | Same |
| Sample Type | Serum
Plasma: Li-heparin, K2-EDTA, K3-
EDTA and fluoride plasma | Same |
| Calibrator | Calibrator f.a.s. | Same |
| Calibration
Frequency | Each lot and as required following
quality control procedures | Same |
| Controls | Precinorm U or Precinorm U Plus
And
Precipath U or Precipath U Plus | Same |
| Reagent Stability | Shelf life at 2 to 8°C
Integra 400/400 Plus: On-board in use
at 10-15°C for 8 weeks
Integra 800: On-board in use at 8°C
for 8 weeks | Same |
| Measuring
Range | Regular Applications:
4.32 - 720 mg/dL
Stat Applications:
4.32 - 541 mg/dL | Regular Applications:
2.16 - 720 mg/dL |
2
Substantial equivalence –
comparison
1/1
| comparison
Feature | COBAS INTEGRA Glucose Gen. 3 Assay
Serum/Plasma Application | | | Predicate Device: COBAS INTEGRA Glucose Gen. 3 Assay
Serum/Plasma Application (K061048) | | |
|--------------------------|----------------------------------------------------------------------|--------------|--------|--------------------------------------------------------------------------------------------|--------------|--------|
| Precision - Serum/Plasma | Serum – Regular Application:
Repeatability (Within-Run Precision) | | | Serum:
Within-Run Precision | | |
| | Sample | Mean (mg/dL) | CV (%) | Sample | Mean (mg/dL) | CV (%) |
| | HS1 | 64.3 | 0.69 | Level I | 80.7 | 0.41 |
| | HS2 | 120 | 0.78 | Level II | 225 | 0.47 |
| | HS3 | 665 | 0.70 | | | |
| | PNU | 90.8 | 0.58 | | | |
| | PPU | 247 | 0.59 | | | |
| | Intermediate (Between Run Precision) | | | Between Run | | |
| | Sample | Mean (mg/dL) | CV (%) | Sample | Mean (mg/dL) | CV (%) |
| | HS1 | 64.3 | 1.26 | Level I | 80.0 | 1.09 |
| | HS2 | 120 | 1.41 | Level II | 225 | 0.90 |
| | HS3 | 665 | 1.32 | | | |
| | PNU | 90.8 | 1.24 | | | |
| | PPU | 247 | 1.21 | | | |
| | Serum - Stat Application:
Repeatability (Within-Run Precision) | | | | | |
| | Sample | Mean (mg/dL) | CV (%) | | | |
| | HS1 | 64.7 | 0.61 | | | |
| | HS2 | 121 | 0.69 | | | |
| | HS3 | 487 | 0.74 | | | |
| | PNU | 91.4 | 0.58 | | | |
| | PPU | 249 | 0.57 | | | |
| | Intermediate (Between Run Precision) | | | | | |
| | Sample | Mean (mg/dL) | CV (%) | | | |
| | HS1 | 64.7 | 1.08 | | | |
| | HS2 | 121 | 1.40 | | | |
| | HS3 | 487 | 1.10 | | | |
| | PNU | 91.4 | 1.15 | | | |
| | PPU | 249 | 1.07 | | | |
3
Substantial equivalence –
| Feature | COBAS INTEGRA Glucose Gen. 3 Assay
Serum/Plasma Application | | | Predicate Device: COBAS INTEGRA Glucose Gen. 3 Assay
Serum/Plasma Application (K061048) | | |
|-------------------|----------------------------------------------------------------------|--------------|--------|--------------------------------------------------------------------------------------------|--------------|--------|
| Precision - Urine | Urine – Regular Application:
Repeatability (Within-Run Precision) | | | Urine:
Within-Run Precision | | |
| | Sample | Mean (mg/dL) | CV (%) | Sample | Mean (mg/dL) | CV (%) |
| | HS1 | 8.65 | 2.28 | Level I | 15.0 | 1.35 |
| | HS2 | 17.3 | 1.05 | Level II | 43.6 | 0.64 |
| | HS3 | 672 | 0.53 | | | |
| | PNU | 90.8 | 0.58 | | | |
| | PPU | 247 | 0.59 | | | |
| | Intermediate (Between Run Precision) | | | Between Run | | |
| | Sample | Mean (mg/dL) | CV (%) | Sample | Mean (mg/dL) | CV (%) |
| | HS1 | 8.65 | 2.83 | Level I | 15.1 | 0.75 |
| | HS2 | 17.3 | 1.37 | Level II | 43.8 | 0.83 |
| | HS3 | 672 | 1.01 | | | |
| | PNU | 90.8 | 1.24 | | | |
| | PPU | 247 | 1.21 | | | |
| | Serum - Stat Application:
Repeatability (Within-Run Precision) | | | | | |
| | Sample | Mean (mg/dL) | CV (%) | | | |
| | HS1 | 8.58 | 2.71 | | | |
| | HS2 | 17.4 | 1.16 | | | |
| | HS3 | 476 | 0.64 | | | |
| | PNU | 91.4 | 0.58 | | | |
| | PPU | 249 | 0.57 | | | |
| | Intermediate (Between Run Precision) | | | | | |
| | Sample | Mean (mg/dL) | CV (%) | | | |
| | HS1 | 8.58 | 3.20 | | | |
| | HS2 | 17.4 | 1.65 | | | |
| | HS3 | 476 | 1.09 | | | |
| | PNU | 91.4 | 1.15 | | | |
| | PPU | 249 | 1.07 | | | |
4
·
Substantial
equivalence –
comparison
ノバイ
、
squares
comparison
| Feature | COBAS INTEGRA Glucose Gen. 3 Assay
Serum/Plasma Application | | | Predicate Device: COBAS INTEGRA Glucose Gen. 3 Assay
Serum/Plasma Application
(K061048) | | |
|---------------------------|------------------------------------------------------------------------------------------------|-----------------|--------|-----------------------------------------------------------------------------------------------|-----------------|--------|
| Precision - CSF | CSF - Regular Application:
Repeatability (Within-Run Precision) | | | CSF - Regular Application:
Within-Run Precision | | |
| | Sample | Mean
(mg/dL) | CV (%) | Sample | Mean
(mg/dL) | CV (%) |
| | Level I | 57.7 | 1.13 | Level I | 57.7 | 1.13 |
| | Level II | 168 | 1.49 | Level II | 168 | 1.49 |
| | CSF - STAT Application:
Repeatability (Within-Run Precision) | | | | | |
| | Sample | Mean
(mg/dL) | CV (%) | | | |
| | CSF 1 | 39.6 | 0.63 | | | |
| | CSF 2 | 283 | 0.39 | | | |
| | CSF 3 | 517 | 0.51 | | | |
| | PNU Plus | 92.4 | 0.53 | | | |
| | PPU Plus | 240 | 0.43 | | | |
| Analytical
Sensitivity | Lower Limits of Measurement:
Limit of Blank = 2.16 mg/dL
Limit of Detection = 4.32 mg/dL | | | Lower Detection Limit:
2.16 mg/dL | | |
ڊ
5
Substantial
equivalence –
| comparison | ||
|---|---|---|
| Feature | COBAS INTEGRA Glucose Gen. 3 | |
| Assay | ||
| Serum/Plasma Application | Predicate Device: COBAS | |
| INTEGRA Glucose Gen. 3 Assay | ||
| Serum/Plasma Application | ||
| (K061048) | ||
| Limitations - | ||
| Interference | Icterus - No significant interference up to | |
| an I index of 60 (approximate | ||
| concentration of conjugated and | ||
| unconjugated bilirubin: 60 mg/dL or | ||
| 1026 umol/L)* | Same | |
| Hemolysis - No significant interference | ||
| up to an H index of 1200 (approximate | ||
| hemoglobin concentration: 1200 mg/dL | ||
| or 744 umol/L)* | Same | |
| Lipemia – No significant interference up | ||
| to an L index of 1900. There is a poor | ||
| correlation between the L index | ||
| (corresponds to turbidity) and the | ||
| triglyceride concentration.* | Same | |
| Other - In very rare cases gammopathy, | ||
| in particular type IgM (Waldenstrom's | ||
| macroglobulinemia), may cause | ||
| unreliable results. | Same | |
| Drugs - No interference was found at | ||
| therapeutic concentrations using common | ||
| drug panels. | Not Specified | |
| *measured at a glucose concentrations of | ||
| approximately 63.07 mg/dL and 297.33 | ||
| mg/dL | ||
| comparison | ||
| Feature | COBAS INTEGRA Glucose Gen. 3 | |
| Assay | ||
| Serum/Plasma Application | Predicate Device: COBAS | |
| INTEGRA Glucose Gen. 3 Assay | ||
| Serum/Plasma Application | ||
| (K061048) | ||
| Expected Values | Plasma | |
| Fasting: 74 - 109 mg/dL | ||
| (Per Thomas L. Blutglucose. In: Thomas L, | ||
| ed. Labor und Diagnose, 6th ed. | ||
| Frankfurt/Main: TH-Books, 2005:193-199.) | Plasma | |
| Fasting: 70 - 115 mg/dL | ||
| (Per Thomas L, ed. Labor und Diagnose, 4th | ||
| ed. Marburg: Die medizinische | ||
| Verlagsgesellschaft 1992.) | ||
| Urine | ||
| 1st morning: 6 - 20 mg/dL | ||
| 24-h urine: 6 - 17 mg/dL | ||
| (average of 1350 mL urine/24 h) | Same | |
| acc. to Tietz: | ||
| Serum,Plasma | ||
| Adults: 74 - 106 mg/dL | ||
| 60-90 years: 82 - 115 mg/dL |
90 years: 75 - 121 mg/dL
Children: 60 - 100 mg/dL
Neonates (1 day): 40 - 60 mg/dL
Neonates (>1 day): 50 - 80 mg/dL | Same |
| | Urine
24-h urine: