(74 days)
No
The summary describes a standard in vitro diagnostic system based on chemical reactions and optical measurements, with no mention of AI or ML.
No.
The device is an in vitro diagnostic reagent system used for quantitative determination of substances in biological samples, not for treating or preventing disease.
Yes
The "Intended Use / Indications for Use" section explicitly states that the COBAS INTEGRA Analyzer and COBAS INTEGRA Reagent Cassettes together "provide an integrated system for in vitro diagnostic testing." It also describes the reagent cassettes as containing "in vitro diagnostic reagent systems" for quantitative determinations of substances in patient samples, which are characteristic activities of diagnostic devices.
No
The device description clearly states it includes "Reagent Cassettes" which are physical components containing chemical reagents for in vitro diagnostic testing. It also mentions the "COBAS INTEGRA Analyzer," a hardware system. The submission focuses on the performance of these physical components and their interaction with the analyzer, not solely on software functionality.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section clearly states: "The COBAS INTEGRA Cassette for Albumin (Turbidimetric) contains an in vitro diagnostic reagent system intended for use on COBAS INTEGRA for the quantitative immunological determination of human albumin in serum and urine." and "The COBAS INTEGRA Cassette for Hemoglobin Alc contains an in vitro diagnostic reagent system intended for the quantitative determination of percent hemoglobin (HbAlc%) in hemolysate."
- Integrated System: The text also says, "The COBAS INTEGRA Analyzer and COBAS INTEGRA Reagent Cassettes together provide an integrated system for in vitro diagnostic testing."
- Nature of the Tests: The tests performed (quantitative determination of albumin in serum and urine, and HbA1c in hemolysate) are performed on samples taken from the human body in vitro (outside the body) to provide information for the diagnosis, treatment, or prevention of disease.
These points definitively indicate that the device is an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The COBAS INTEGRA Cassette for Albumin (Turbidimetric) contains an in vitro diagnostic reagent system intended for use on COBAS INTEGRA for the quantitative immunological determination of human albumin in serum and urine. The COBAS INTEGRA Cassette for Hemoglobin Alc contains an in vitro diagnostic reagent system intended for the quantitative determination of percent hemoglobin (HbAlc%) in hemolysate.
Product codes (comma separated list FDA assigned to the subject device)
966.5040, 864.7470, 862.3320
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 2-8ºC. 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. This submission also contains a modification to the previously cleared COBAS INTEGRA Reagent Cassette for Digoxin. The COBAS INTEGRA Reagent Cassette for Digoxin has been modified to include the use of heparinized samples.
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 Albumin (Turbidimetric) in urine | Behring N Antiserum to Human Albumin (BNA Nephelometer) | |
|---|---|---|
| Methodology | Immunoturbidimetric | Immunoturbidimetric |
| Sample type | Urine | Serum, umbilical cord serum, CSF and urine |
| Calibrator | Roche Serumproteins T Standard | Behring N Protein Standard PY |
| Reagent (active ingredients) | 1. Anti-albumin T antiserum (rabbit) in phosphate buffer | 1. Antiserum to human albumin 2. Phosphate buffered saline |
| Performance Characteristics: | ||
| Assay range | 6-193 mg/L 6-3860 mg/L w/postdilution | Not specified in labeling |
| Precision (Within-run) | 4.3 % at 10 mg/L 1.2 % at 223 mg/L | Not specified in labeling |
| Accuracy | N = 200 R = 0.997 vs. Behring Albumin | Not specified in labeling |
| Sensitivity (Analytical) | 7 mg/L | Not specified in labeling |
| COBAS INTEGRA Cassette for HbA1c | Roche Unimate HbA1c Reagent on COBAS MIRA | |
|---|---|---|
| Methodology | Immunoturbidimetric test for HbA1c Colorimetric test for Total Hb | Immunoturbidimetric test for HbA1c Colorimetric test for Total Hb |
| Sample type | Anticoagulated venous or capillary whole blood (heparin, EDTA, citrate or oxalate/fluoride) | Anticoagulated venous or capillary whole blood (heparin, EDTA, citrate or oxalate/fluoride) |
| Application | Hemolysate | Hemolysate or whole blood |
| Reported measuring units | % HbA1c | % HbA1c |
| Calibrator | Roche HbA1c Calibrator | Roche HbA1c Calibrator |
| Reagent (active ingredients) | R1. Potassium phosphate buffer Tensides R2. Latex coated with monoclonal (mouse) antibody specific for HbA1c Bovine serum albumin NaCl HEPPS Buffer R3. Agglutinator (synthetic polyvalent antigen ) Bovine serum albumin Formate buffer | R1. Latex coated with monoclonal (mouse) antibody specific for HbA1c Bovine serum albumin NaCl HEPPS Buffer R2. Potassium phosphate buffer Tensides R3. Agglutinator (synthetic polyvalent antigen ) Bovine serum albumin Formate buffer |
| Performance Characteristics: | ||
| Assay range | 3-30.9 % | 2-25 % |
| Precision (Total) | Mean % CV % 4.8 % 2.8 % 12.1 % 2.4 % | Mean % CV % 5.3 % 4.0 % 12.9 % 4.9 % |
| Accuracy | N = 240 R = 0.994 vs. Roche Unimate Reagent | N = 208 R = 0.943 vs. BM Tina- quant HbA1c Reagent |
| Sensitivity (Analytical) | 0.90 umol/L for hemoglobin 0.22 umol/L for HbA1c | 0.76 umol/L for hemoglobin 0.78 umol/L for HbA1c |
| COBAS INTEGRA Cassette for Digoxin (Modified) | COBAS INTEGRA Cassette for Digoxin (Cleared) | |
|---|---|---|
| Methodology | Kinetic interaction of microparticles in solution | Kinetic interaction of microparticles in solution |
| Sample type | Serum and heparinized plasma | Serum |
| Calibrator | COBAS-FP Digoxin Calibrators (K951595) | COBAS-FP Digoxin Calibrators (K951595) |
| Controls | COBAS-FP TDM Controls (K954992) | COBAS-FP TDM Controls (K954992) |
| Reagent (active ingredients) | 0 Anti-digoxin monoclonal antibody (mouse) in buffer 1 Conjugated digoxin derivative microparticles in buffer | 0 Anti-digoxin monoclonal antibody (mouse) in buffer 1 Conjugated digoxin derivative microparticles in buffer |
| Performance Characteristics: | ||
| Assay range | 0.17 - 5.0 ng/mL | 0.17 - 5.0 ng/mL |
| Precision (Total) | 9.7 % at 0.87 ng/mL 6.1 % at 1.64 ng/mL 3.9 % at 2.82 ng/mL | 14.4 % at 0.81 ng/mL 5.3 % at 1.57 ng/mL 3.8 % at 4.1 ng/mL |
| Accuracy | N = 63 R = 0.967 vs. TDx (FPIA) | N = 189 R = 0.958 vs. TDx (FPIA) |
| Sensitivity (Analytical) | 0.17 ng/mL | 0.17 ng/mL |
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
See "Summary of Performance Studies" for metrics listed including:
- Assay range
- Precision (Within-run and Total)
- Accuracy (R-value)
- Sensitivity (Analytical)
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
§ 866.5040 Albumin immunological test system.
(a)
Identification. An albumin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the albumin (a plasma protein) in serum and other body fluids. Measurement of albumin aids in the diagnosis of kidney and intestinal diseases.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 866.9.
0
JUL 23 1996
Rache
Roche Diagnostic Systems
A Member of the Roche Group
Roche Diagnostic Systems, Inc Branchburg Township 1080 U.S. Highway 202 Somerville, New Jersey 08876-3771
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.
Identification of 510(k) Sponsor: I.
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 May 8, 1996
Contact: Maria Feijoo Regulatory Affairs Associate Phone: (908) 253-7310 (908) 253-7547 Fax:
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 |
|-----------------------------------------------------|-----------------------------------------|---------------------|---------------------------------|--------------------------------------------|------------------------------|-------------------------------|
| COBAS INTEGRA
Albumin (ALB-T)
(Turbidimetric) | Albumin
immunological
test system | Class II | 966.5040 | Behring N
Antiserum to
Human Albumin | 4/15/86 | K860894 |
| COBAS INTEGRA
HbA1c (HBA1C) | Glycosylated
hemoglobin
assay | Class II | 864.7470 | Roche Unimate
HBA1c Reagent | 2/9/96 | K952337/S1 |
| COBAS INTEGRA
Digoxin (DIG)
modification | Digoxin test
system | Class II | 862.3320 | COBAS INTEGRA
Digoxin | 9/8/95 | K951595 |
1
Identification of the legally marketed device to which the 510(k) sponsor III. claims equivalence:
The following table identifies the legally marketed devices to which Roche Diagnostic Systems, Inc. claims equivalence.
| Product Name | Classification
Name | Regulatory
Class | CFR
Classification
Number | Predicate
Product
Name | Date
Predicate
Cleared | Predicate
510(k)
Number |
|-----------------------------------------------------|-----------------------------------------|---------------------|---------------------------------|--------------------------------------------|------------------------------|-------------------------------|
| COBAS INTEGRA
Albumin (ALB-T)
(Turbidimetric) | Albumin
immunological
test system | Class II | 966.5040 | Behring N
Antiserum to
Human Albumin | 4/15/86 | K860894 |
| COBAS INTEGRA
HbA1c (HBA1C) | Glycosylated
hemoglobin
assay | Class II | 864.7470 | Roche Unimate
HBA1c Reagent | 2/9/96 | K952337/S1 |
| COBAS INTEGRA
Digoxin (DIG)
modification | Digoxin test
system | Class II | 862.3320 | COBAS INTEGRA
Digoxin | 9/8/95 | K951595 |
IV. Description of the Device/Statement of Intended Use:
Through this submission, it is the intention of Roche to gain clearance of an additional 2 COBAS Reagent Cassettes. The 2 COBAS INTEGRA Reagent Cassettes contained in this submission are intended for use with the COBAS INTEGRA Analyzer. These are the COBAS INTEGRA Cassette for Albumin-T in urine and the COBAS INTEGRA Cassette for HbA1c. The COBAS INTEGRA Cassette for Albumin (Turbidimetric) contains an in vitro diagnostic reagent system intended for use on COBAS INTEGRA for the quantitative immunological determination of human albumin in serum and urine. The COBAS INTEGRA Cassette for Hemoglobin Alc contains an in vitro diagnostic reagent system intended for the quantitative determination of percent hemoglobin (HbAlc%) in hemolysate. 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 2-8ºC. 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.
This submission also contains a modification to the previously cleared COBAS INTEGRA Reagent Cassette for Digoxin. The COBAS INTEGRA Reagent Cassette for Digoxin has been modified to include the use of heparinized samples.
2
ー
v. Summary of the technological characteristics of the new device in comparison to those of the predicate.
Tables 1, 2 and 3 attached to this summary outline the technological characteristics (methodologies) of the COBAS INTEGRA Reagents in comparison to those of legally marketed predicate products.
3
VI. Brief discussion of the clinical and nonclinical tests relied on for a determination of substantial equivalence:
Tables 1, 2 and 3 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.
| | COBAS INTEGRA
Cassette for Albumin
(Turbidimetric) in urine | Behring N Antiserum to
Human Albumin
(BNA Nephelometer) | | |
|------------------------------|-------------------------------------------------------------------|------------------------------------------------------------------|--|--|
| Methodology | Immunoturbidimetric | Immunoturbidimetric | | |
| Sample type | Urine | Serum, umbilical cord
serum, CSF and urine | | |
| Calibrator | Roche Serumproteins T
Standard | Behring N Protein Standard
PY | | |
| Reagent (active ingredients) | 1. Anti-albumin T
antiserum (rabbit) in
phosphate buffer | 1. Antiserum to human
albumin
2. Phosphate buffered saline | | |
| Performance Characteristics: | | | | |
| Assay range | 6-193 mg/L
6-3860 mg/L w/postdilution | Not specified in labeling | | |
| Precision (Within-run) | 4.3 % at 10 mg/L
1.2 % at 223 mg/L | Not specified in labeling | | |
| Accuracy | N = 200
R = 0.997 vs. Behring
Albumin | Not specified in labeling | | |
| Sensitivity (Analytical) | 7 mg/L | Not specified in labeling | | |
Table 1
4
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Table 2
| | COBAS INTEGRA
Cassette for HbA1c | Roche Unimate HbA1c
Reagent on COBAS MIRA |
|-------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Methodology | Immunoturbidimetric test for HbA1c
Colorimetric test for Total Hb | Immunoturbidimetric test for HbA1c
Colorimetric test for Total Hb |
| Sample type | Anticoagulated venous or capillary whole blood
(heparin, EDTA, citrate or oxalate/fluoride) | Anticoagulated venous or capillary whole blood
(heparin, EDTA, citrate or oxalate/fluoride) |
| Application | Hemolysate | Hemolysate or whole blood |
| Reported measuring units | % HbA1c | % HbA1c |
| Calibrator | Roche HbA1c Calibrator | Roche HbA1c Calibrator |
| Reagent (active ingredients) | R1. Potassium phosphate buffer
Tensides
R2. Latex coated with
monoclonal (mouse) antibody specific for HbA1c
Bovine serum albumin
NaCl
HEPPS Buffer
R3. Agglutinator (synthetic polyvalent antigen )
Bovine serum albumin
Formate buffer | R1. Latex coated with
monoclonal (mouse)
antibody specific for HbA1c
Bovine serum albumin
NaCl
HEPPS Buffer
R2. Potassium phosphate buffer
Tensides
R3. Agglutinator (synthetic polyvalent antigen )
Bovine serum albumin
Formate buffer |
| Performance Characteristics: | | |
| Assay range | 3-30.9 % | 2-25 % |
| Precision (Total) | Mean % CV %
4.8 % 2.8 %
12.1 % 2.4 % | Mean % CV %
5.3 % 4.0 %
12.9 % 4.9 % |
| Accuracy | N = 240
R = 0.994 vs. Roche
Unimate Reagent | N = 208
R = 0.943 vs. BM Tina-
quant HbA1c Reagent |
| Sensitivity (Analytical) | 0.90 umol/L for hemoglobin
0.22 umol/L for HbA1c | 0.76 umol/L for hemoglobin
0.78 umol/L for HbA1c |
5
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Table 3
| | COBAS INTEGRA
Cassette for Digoxin
(Modified) | COBAS INTEGRA
Cassette for Digoxin
(Cleared) |
|------------------------------|------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------|
| Methodology | Kinetic interaction of
microparticles in solution | Kinetic interaction of
microparticles in solution |
| Sample type | Serum and heparinized
plasma | Serum |
| Calibrator | COBAS-FP Digoxin
Calibrators (K951595) | COBAS-FP Digoxin
Calibrators (K951595) |
| Controls | COBAS-FP TDM Controls
(K954992) | COBAS-FP TDM Controls
(K954992) |
| Reagent (active ingredients) | 0 Anti-digoxin monoclonal
antibody (mouse) in
buffer
1 Conjugated digoxin
derivative microparticles
in buffer | 0 Anti-digoxin monoclonal
antibody (mouse) in
buffer
1 Conjugated digoxin
derivative microparticles
in buffer |
| Performance Characteristics: | | |
| Assay range | 0.17 - 5.0 ng/mL | 0.17 - 5.0 ng/mL |
| Precision (Total) | 9.7 % at 0.87 ng/mL
6.1 % at 1.64 ng/mL
3.9 % at 2.82 ng/mL | 14.4 % at 0.81 ng/mL
5.3 % at 1.57 ng/mL
3.8 % at 4.1 ng/mL |
| Accuracy | N = 63
R = 0.967 vs. TDx (FPIA) | N = 189
R = 0.958 vs. TDx (FPIA) |
| Sensitivity (Analytical) | 0.17 ng/mL | 0.17 ng/mL |
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