(71 days)
Not Found
No
The summary describes a standard in vitro diagnostic system for quantitative measurement of analytes using established principles (absorbance, fluorescence polarization, ion-selective electrodes). There is no mention of AI or ML in the intended use, device description, or performance studies. The focus is on the reagents and the analyzer's ability to perform the assays.
No
The device is described as an "in vitro diagnostic system" used for quantitative measurement of analytes, which falls under diagnostic purposes rather than therapeutic treatment.
Yes.
The document explicitly states that the device provides an "integrated system for in vitro diagnostic testing" and that the reagent cassettes are "in vitro diagnostic reagent systems."
No
The device is described as an integrated system consisting of an analyzer (hardware) and reagent cassettes (consumables/hardware). While software is undoubtedly involved in controlling the analyzer and processing data, the core of the device includes physical components and chemical reagents, making it a hardware-based medical device with associated software.
Yes, this device is an IVD (In Vitro Diagnostic).
The document explicitly states in the "Intended Use / Indications for Use" section:
- "The COBAS INTEGRA Analyzer and COBAS INTEGRA Reagent Cassettes together provide an integrated system for in vitro diagnostic testing."
- "The COBAS INTEGRA Cassette for Antithrombin III (AT III) contains an in vitro diagnostic reagent system intended for use on COBAS INTEGRA for the quantitative determination of human antithrombin III activity in plasma."
- "The COBAS INTEGRA Cassette for Ferritin contains an in vitro diagnostic reagent system intended for the quantitative immunological determination of human ferritin in serum."
- "The COBAS INTEGRA Cassette for Myoglobin contains an in vitro diagnostic reagent system intended for use on COBAS INTEGRA for the quantitative immunological determination of human myoglobin in serum and plasma."
- "The COBAS INTEGRA Cassette for Rheumatoid Factors contains an in vitro diagnostic reagent system intended for use on COBAS INTEGRA for the quantitative immunological determination of human rheumatoid factors in serum."
These statements clearly indicate that the device and its components are intended for use in diagnostic testing performed outside of the living body, which is the definition of an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The COBAS INTEGRA Reagent Cassettes are comprised of chemistry, drugs of abuse, immunology, therapeutic drug monitoring, and hematology assay systems. The COBAS INTEGRA Cassette for Antithrombin III (AT III) contains an in vitro diagnostic reagent system intended for use on COBAS INTEGRA for the quantitative determination of human antithrombin III activity in plasma. The COBAS INTEGRA Cassette for Ferritin contains an in vitro diagnostic reagent system intended for the quantitative immunological determination of human ferritin in serum. The COBAS INTEGRA Cassette for Myoglobin contains an in vitro diagnostic reagent system intended for use on COBAS INTEGRA for the quantitative immunological determination of human myoglobin in serum and plasma. The COBAS INTEGRA Cassette for Rheumatoid Factors contains an in vitro diagnostic reagent system intended for use on COBAS INTEGRA for the quantitative immunological determination of human rheumatoid factors in serum. Plasmachrom Calibrator is intended for use as a calibrator in quantitative kinetic antithrombin III activity assays. Plasmachrom Control N is an assayed control intended for use to monitor the accuracy and precision at normal concentration levels in quantitative kinetic colorimetric tests for antithrombin III activity assays. Plasmachrom Control P is an assayed control intended for use to monitor the accuracy and precision at pathological concentration levels in quantitative kinetic colorimetric tests for antithrombin III activity assays. MYOT Standard is intended for use as a calibrator in quantitative determinations of human myoglobin. FERR T Standard is intended for use as a calibrator in quantitative determinations of human ferritin. FERR/MYO T Control is intended for use as a quality control material to monitor accuracy and precision in quantitative determinations of human ferritin and myoglobin. RF T Standard is intended for use as a calibrator in quantitative determinations of human rheumatoid factor.
Product codes (comma separated list FDA assigned to the subject device)
Not Found
Device Description
The COBAS INTEGRA Analyzer and COBAS INTEGRA Reagent Cassettes together provide an integrated system for in vitro diagnostic testing. The COBAS INTEGRA Reagent Cassettes are comprised of chemistry, drugs of abuse, immunology, therapeutic drug monitoring, and hematology assay systems. The COBAS INTEGRA Analyzer provides quantitative measurement of these analytes via three measuring principles, i.e., absorbance, fluorescence polarization and ion-selective electrodes. The COBAS INTEGRA Reagent Cassettes are compact and preparation-free with the added convenience of long term on-board stability. Sixty-eight COBAS INTEGRA Reagent Cassettes can be stored on board, 24 hours a day at 2-8℃. Each cassette is barcoded. This barcode label provides the analyzer with specific reagent information such as the lot number. the expiration date and the number of tests.
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)
COBAS INTEGRA Cassette for AT III:
- Methodology: Kinetic colorimetric test
- Sample type: Plasma (citrate)
- Reported measuring units: %
- Assay range: 0-150%
- Precision (Day-to-day): 4.1% at 51.9%, 2.8% at 105.7%
- Accuracy: N = 200, R = 0.973 vs. Berichrom Reagent
- Sensitivity (Analytical): 1.6 X 10-3 ΔA/min per % change in AT III activity
COBAS INTEGRA Cassette for Ferritin:
- Methodology: Immunoturbidimetric test for Ferritin
- Sample type: Serum
- Reported measuring units: ug/L
- Assay range: 0-300 ug/L; 0-3000 ug/L w/postdilution
- Precision (Within-run): 9.9 % at 19 ug/L, 1.2 % at 260 ug/L
- Accuracy: N = 188, y = 0.80x + 2.9 ug/L vs. Behring N Latex Ferritin
- Sensitivity (Analytical):
§ 862.1145 Calcium test system.
(a)
Identification. A calcium test system is a device intended to measure the total calcium level in serum. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms).(b)
Classification. Class II.
0
Image /page/0/Picture/1 description: The image shows the logo for Roche Diagnostic Systems. The logo consists of the Roche symbol on the left, followed by the text "Roche Diagnostic Systems" in bold, sans-serif font. The Roche symbol is a stylized graphic, and the text is aligned horizontally.
A Member of the Roche Group
OCT 31 1988
Roche Diagnostic Systems, Inc. 1080 U.S. Highway 202 Branchourg, New Jersey 08876-1760
Direct Dial Fax
510(k) Summary
Roche COBAS® INTEGRA Reagent Cassettes
In accordance with the Safe Medical Devices Act of 1990, a 510(k) summary is provided as outlined in 21 CFR 807.92.
I. Identification of 510(k) Sponsor:
Roche Diagnostic Systems, Inc. a subsidiary of Hoffmann-La Roche. Inc. Branchburg Township 1080 U.S. Highway 202 Somerville, New Jersey 08876-3771
510(k) Submission dated August 20, 1996
Contact: Andrea Casper Sr. Manager Regulatory and Clinical Affairs Phone: (908) 253-7332 Fax: (908) 253-7547
II. Device Name:
The device name, including both the trade/proprietary name and the classification name are provided in the table below.
| Product Name | Classification
Name | Regulatory
Class | CFR
Classification
Number | Predicate
Product
Name | Date
Predicate
Cleared | Predicate
510(k)
Number |
|--------------------------------------------|---------------------------|---------------------|---------------------------------|---------------------------------------------------------------------------|------------------------------|-------------------------------|
| Chemistry Panel | | | | | | |
| COBAS INTEGRA
Calcium
(modification) | Calcium test
system | Class II | 862.1145 | COBAS INTEGRA
Calcium
Boehringer
Mannheim
Calcium Reagent | 9/5/95
1/23/85 | K951595
K850281 |
| Immunology Panel | | | | | | |
| COBAS INTEGRA
Antithrombin III | Antithrombin III
assay | Class II | 866.7060 | Berichrom
Antithrombin III
Reagent | 4/19/94 | K933125 |
Table 1
1
| COBAS INTEGRA
Ferritin | Ferritin
immunological
test system | Class II | 866.5340 | Behring N Latex
Ferritin Reagent | 3/27/95 | K950707 |
|-------------------------------------|--------------------------------------------------------|----------|----------|-----------------------------------------|----------|---------|
| COBAS INTEGRA
Myoglobin | Myoglobin
immunological
test system | Class II | 866.5680 | Behring N Latex
Myoglobin
Reagent | 6/01/96 | K902154 |
| COBAS INTEGRA
Rheumatoid Factors | Rheumatoid
factor
immunological
test system | Class II | 866.5775 | Behring N Latex
RF Reagent | 10/20/94 | K942328 |
| Plasmachrom
Calibrator | Calibrator | Class II | 862.1150 | Behring N Protein
Standard Plasma | 4/7/88 | K883662 |
| Plasmachrom
Controls | Quality control
material (assayed
and unassayed) | Class I | 862.1660 | N/T Protein
Control Py | 4/17/96 | K951012 |
| Roche FERR T
Standard | Calibrator | Class II | 862.1150 | Behring N Ferritin
Standard | 3/27/95 | K950707 |
| Roche FERR/MYO
T Control | Quality control
material (assayed
and unassayed) | Class I | 862.1660 | Behring N Ferritin
Controls | 3/27/95 | K950707 |
| | | | | Behring N
Myoglobin
Controls | 6/01/96 | K902154 |
| Roche MYO T
Standard | Calibrator | Class II | 862.1150 | Behring N
Myoglobin
Standard | 6/01/96 | K902154 |
| Roche RF T
Standard | Calibrator | Class II | 862.1150 | Behring N RF
Standard | 10/20/94 | K942328 |
III. Identification of the legally marketed device to which the 510(k) sponsor claims equivalence:
Table 1, presented above, identifies the legally marketed devices to which Roche Diagnostic Systems, Inc. claims equivalence.
IV. Description of the Device/Statement of Intended Use:
The COBAS INTEGRA Analyzer and COBAS INTEGRA Reagent Cassettes together provide an integrated system for in vitro diagnostic testing. The COBAS INTEGRA Reagent Cassettes are comprised of chemistry, drugs of abuse, immunology, therapeutic drug monitoring, and hematology assay systems. The COBAS INTEGRA Analyzer provides quantitative measurement of these analytes via three measuring principles, i.e., absorbance, fluorescence polarization and ion-selective electrodes. The COBAS INTEGRA Reagent Cassettes are compact and preparation-free with the added convenience of long term on-board stability. Sixty-eight COBAS INTEGRA Reagent Cassettes can be stored on board, 24 hours a day at 2-8℃. Each cassette is barcoded. This barcode label provides the analyzer with specific reagent information such as the lot number. the expiration date and the number of tests.
2
Through this submission, it is the intention of Roche to gain clearance of an additional 4 COBAS Reagent Cassettes and 6 ancillary reagents. These are the COBAS INTEGRA Cassette for Antithrombin III, COBAS INTEGRA Cassette for Ferritin, COBAS INTEGRA Cassette for Myoglobin, COBAS INTEGRA Cassette for Rheumatoid Factors, Roche Plasmachrom Calibrator, Roche Plasmachrom N & P Controls, Roche FERR T Standard, Roche FERR/MYO T Control, Roche MYOT Standard, and Roche RF Standard II. The COBAS INTEGRA Cassette for Antithrombin III (AT III) contains an in vitro diagnostic reagent system intended for use on COBAS INTEGRA for the quantitative determination of human antithrombin III activity in plasma. The COBAS INTEGRA Cassette for Ferritin contains an in vitro diagnostic reagent system intended for the quantitative immunological determination of human ferritin in serum. The COBAS INTEGRA Cassette for Myoglobin contains an in vitro diagnostic reagent system intended for use on COBAS INTEGRA for the quantitative immunological determination of human myoglobin in serum and plasma. The COBAS INTEGRA Cassette for Rheumatoid Factors contains an in vitro diagnostic reagent system intended for use on COBAS INTEGRA for the quantitative immunological determination of human rheumatoid factors in serum. Plasmachrom Calibrator is intended for use as a calibrator in quantitative kinetic antithrombin III activity assays. Plasmachrom Control N is an assayed control intended for use to monitor the accuracy and precision at normal concentration levels in quantitative kinetic colorimetric tests for antithrombin III activity assays. Plasmachrom Control P is an assayed control intended for use to monitor the accuracy and precision at pathological concentration levels in quantitative kinetic colorimetric tests for antithrombin III activity assays. MYOT Standard is intended for use as a calibrator in quantitative determinations of human myoglobin. FERR T Standard is intended for use as a calibrator in quantitative determinations of human ferritin. FERR/MYO T Control is intended for use as a quality control material to monitor accuracy and precision in quantitative determinations of human ferritin and myoglobin. RF T Standard is intended for use as a calibrator in quantitative determinations of human rheumatoid factor.
This submission also contains a modification to the previously cleared COBAS INTEGRA Reagent Cassette for Calcium. The performance of the COBAS INTEGRA Reagent Cassette for Calcium has been improved due to the use of new instrument parameters .
-
V . Summary of the technological characteristics of the device new in comparison to those of the predicate.
Tables 2-6 attached to this summary outline the technological characteristics (methodologies) of the COBAS INTEGRA Reagents in comparison to those of legally marketed predicate products. -
VI. Brief discussion of the clinical and nonclinical tests relied on for a determination of substantial equivalence:
Tables 2-6 attached to this summary demonstrate the results of clinical and nonclincal studies performed using the COBAS INTEGRA Reagent Cassettes. The significant performance characteristics relied upon for a determination of substantial equivalence are summarized in this chart. This information concludes that the performance of this device is essentially equivalent to other legally marketed devices of a similar kind.
3
Table 2
COBAS INTEGRA Cassette for AT III
| | COBAS INTEGRA
Cassette for
Antithrombin III | Berichrom AT III (A) |
|------------------------------|------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------|
| Methodology | Kinetic colorimetric test | Kinetic colorimetric test |
| Sample type | Plasma (citrate) | Plasma |
| Reported measuring units | % | % |
| Calibrator | Plasmachrom Calibrator
(lyophilized human plasma)
Calibrator value: 102% | Behring N Protein Standard
Plasma (lyophilized human
plasma)
Calibrator Value: 87% |
| Controls | Plasmachrom N & P Controls
(lyophilized human plasma)
Control N: 99.4%
Control P: 61.1% | N/T Protein Control Py
(lyophilized human plasma)
Control N: 92%
Control P: 34% |
| Reagent (active ingredients) | TRIS
NaCl
Citrate
BSA
Heparin
Thrombin
D-phenylalanyl-prolyl-
arginyl-4-acetylanilide | Thrombin
tos-gly-pro-arg-ANBA-IPA
TRIS |
| Performance Characteristics: | | |
| Assay range | 0-150% | 0-140% |
| Precision (Day-to-day) | 4.1% at 51.9%
2.8% at 105.7% | Normal plasma - 1.0-2.5%
Pathological plasma-1.5-
3.0% |
| Accuracy | N = 200
R = 0.973 vs. Berichrom
Reagent | R = > 0.95 |
| Sensitivity (Analytical) | 1.6 X 10-3 ΔA/min per %
change in AT III activity | Not specified in labeling |
4
Accuracy
Sensitivity (Analytical)
1.3% at 30 ug/L 1.5% at 50 ug/L 0.9% at 200 ug/L
y = 1.01x - 0.37 ug/L vs. enzyme immunoassay
N = 44
5 ug/L
Table 3
COBAS INTEGRA Cassette for Ferritin
| | COBAS INTEGRA
Cassette for Ferritin | Behring N Latex
Ferritin Reagent on
Behring Nephelometer | | |
|------------------------------|-----------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|
| Methodology | Immunoturbidimetric test for
Ferritin | Immunoturbidimetric test for
Ferritin | | |
| Sample type | Serum | Serum | | |
| Reported measuring units | ug/L | ug/L | | |
| Calibrator | Roche FERR T Standard
(human sourced)
0, 12.5, 50, 100, 200, & 300
ug/L | Behring N Ferritin Standard
(human sourced)
344 ug/L | | |
| Controls | Roche FERR/MYO T Control
(lyophilized human serum
w/added BSA)
Ferritin: 126 ± 13 ug/L
Myoglobin: 115 ± 12 ug/L | Behring N Ferritin Controls
(human sourced)
Control 1: 20.2 ug/L
Control 2: 153 ug/L | | |
| Reagent (active ingredients) | R1. Glycine buffer
R2. Latex particles coated
with anti-human ferritin
(rabbit) in glycine buffer | R1. Freeze dried polystyrene
particles coated with rabbit
anti-human ferritin
R2. Buffered solution of
rabbit serum
R3. buffered solution of
detergents | | |
| Performance Characteristics: | | | | |
| Assay range | 0-300 ug/L
0-3000 ug/L w/postdilution | 5-320 ug/L | | |
| Precision (Within-run) | 9.9 % at 19 ug/L
1.2 % at 260 ug/L | 3.8% at 5 ug/L
1.5% at 15 ug/L | | |
N = 188
Reagent