COBAS INTEGRA REAGENT CASSETTES FOR ALBUMIN, HBALC AND DIGOXIN
Device Facts
| Record ID | K961824 |
|---|---|
| Device Name | COBAS INTEGRA REAGENT CASSETTES FOR ALBUMIN, HBALC AND DIGOXIN |
| Applicant | Roche Diagnostic Systems, Inc. |
| Product Code | DCF · Immunology |
| Decision Date | Jul 23, 1996 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 866.5040 |
| Device Class | Class 2 |
Intended 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 A1c contains an in vitro diagnostic reagent system intended for the quantitative determination of percent hemoglobin (HbA1c%) in hemolysate. The COBAS INTEGRA Analyzer and COBAS INTEGRA Reagent Cassettes together provide an integrated system for in vitro diagnostic testing.
Device Story
COBAS INTEGRA Reagent Cassettes are preparation-free, barcoded reagent systems for use with the COBAS INTEGRA Analyzer. The analyzer performs quantitative measurements of analytes (chemistry, drugs of abuse, immunology, therapeutic drug monitoring, hematology) using absorbance, fluorescence polarization, and ion-selective electrodes. Cassettes are stored on-board at 2-8°C; barcodes provide lot, expiration, and test count data to the analyzer. The system automates diagnostic testing in clinical laboratory settings. Healthcare providers use the quantitative outputs to assess patient health status, monitor therapeutic drug levels, or manage conditions like diabetes. The modification to the Digoxin cassette enables the use of heparinized plasma samples in addition to serum.
Clinical Evidence
Bench testing only. Performance evaluated via precision, accuracy, and sensitivity studies. Albumin assay (N=200) showed R=0.997 vs. Behring. HbA1c assay (N=240) showed R=0.994 vs. Roche Unimate. Digoxin modification (N=63) showed R=0.967 vs. TDx. Precision metrics (CV%) provided for all assays across multiple concentration levels.
Technological Characteristics
Reagent cassettes for automated analyzer; barcoded for automated identification. Methodologies: immunoturbidimetric (Albumin, HbA1c), kinetic interaction of microparticles (Digoxin). Measuring principles: absorbance, fluorescence polarization, ion-selective electrodes. Storage: 2-8°C on-board. Reagents include monoclonal antibodies, latex particles, and buffers.
Indications for Use
Indicated for quantitative immunological determination of human albumin in serum and urine, and quantitative determination of percent hemoglobin (HbA1c%) in hemolysate for clinical diagnostic testing.
Regulatory Classification
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.
Special Controls
*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.
Predicate Devices
- Behring N Antiserum to Human Albumin (K860894)
- Roche Unimate HBA1c Reagent (K952337/S1)
- COBAS INTEGRA Digoxin (K951595)
Reference Devices
- COBAS-FP TDM Controls (K954992)
- TDx (FPIA)
- BM Tina-quant HbA1c Reagent
Related Devices
- K964457 — ROCHE COBAS IBTEGRA REAGENT CASSETTES · Roche Diagnostic Systems, Inc. · Jan 13, 1997
- K981897 — ROCHE COBAS INTEGRA ALKALINE PHOSPHATASE IFCC LIQUID REAGENT CASSETTE, ROCHE COBAS INTEGRA PANCREATIC A-AMYLASE EPS REAE · Roche Diagnostic Systems, Inc. · Aug 26, 1998
- K963292 — COBAS INTEGRA REAGENT CASSETTES & ANCILLARY REAGENTS · Roche Diagnostic Systems, Inc. · Oct 31, 1996
- K980996 — COBAS INTEGRA CARBON DIOXIDE (CO2-S), COBAS INTEGRA GLUCOSE HK LIQUID (GLULF) · Roche Diagnostic Systems, Inc. · Jun 5, 1998
- K972250 — ROCHE COBAS INTEGRA REAGENT CASSETTES & ANCILLARY REAGENTS · Roche Diagnostic Systems, Inc. · Aug 12, 1997
Submission Summary (Full Text)
{0}
JUL 23 1996
K961824
Roche
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.
### 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 May 8, 1996
Contact:
Maria Feijoo
Regulatory Affairs Associate
Phone: (908) 253-7310
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 |
| --- | --- | --- | --- | --- | --- | --- |
| 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}
Roche Diagnostic Systems, Inc.
Somerville, New Jersey 08876
May 1996
Roche COBAS® INTEGRA Reagent Cassettes
510(k) Premarket Notification
Summary
## III. Identification of the legally marketed device to which the 510(k) sponsor 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 A1c contains an in vitro diagnostic reagent system intended for the quantitative determination of percent hemoglobin (HbA1c%) 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 2-8°C. 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}
Roche Diagnostic Systems, Inc.
Somerville, New Jersey 08876
May 1996
Roche COBAS® INTEGRA Reagent Cassettes
510(k) Premarket Notification
Summary
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}
Roche Diagnostic Systems, Inc.
Somerville, New Jersey 08876
May 1996
Roche COBAS® INTEGRA Reagent Cassettes
510(k) Premarket Notification
Summary
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 nonclinical 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.
Table 1
| | 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 |
{4}
Roche Diagnostic Systems, Inc.
Somerville, New Jersey 08876
May 1996
Roche COBAS® INTEGRA Reagent Cassettes
510(k) Premarket Notification
Summary
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 %
4.8 %
12.1 % | CV %
2.8 %
2.4 % | Mean %
5.3 %
12.9 % | CV %
4.0 %
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}
Roche Diagnostic Systems, Inc.
Somerville, New Jersey 08876
May 1996
Roche COBAS® INTEGRA Reagent Cassettes
510(k) Premarket Notification
Summary
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 |
