(68 days)
No
The document describes in vitro diagnostic reagent systems for quantitative determination of various analytes using standard laboratory techniques (absorbance, fluorescence polarization, ion-selective electrodes) on a specific analyzer. There is no mention of AI or ML in the intended use, device description, or performance studies. The analysis relies on chemical reactions and physical measurements, not algorithmic learning or pattern recognition.
No
The device is described as an in vitro diagnostic reagent system for quantitatively determining various analytes in biological samples (serum, plasma, urine, CSF). Its purpose is to provide diagnostic information, not to treat or cure a disease or condition.
Yes
The document explicitly states that the reagent systems are "in vitro diagnostic reagent system[s]" and are used for the quantitative determination of various substances in biological samples like serum, plasma, urine, and cerebrospinal fluid, which are typical applications for diagnostic devices.
No
The device is described as "COBAS INTEGRA Reagent Cassettes" which are physical components containing in vitro diagnostic reagents. These cassettes are intended for use with the COBAS INTEGRA Analyzer, a hardware system. The submission focuses on the reagent cassettes themselves, not solely on software.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states that the reagent systems are "in vitro diagnostic reagent system intended for use on COBAS INTEGRA for the quantitative determination of..." various analytes in biological samples (serum, plasma, urine, cerebrospinal fluid). This directly aligns with the definition of an in vitro diagnostic device, which is used to examine specimens taken from the human body to provide information for diagnosis, monitoring, or treatment.
N/A
Intended Use / Indications for Use
- COBAS INTEGRA Gamma- Glutamyltransferase - IFCC: contains an in vitro diagnostic reagent system intended for use on COBAS INTEGRA for the quantitative determination of the catalytic activity of GGT, (EC 2.3.2.2, y-glutamyl peptide: amino acid y-glutamyltransferase) in serum and plasma (test GGTI, 0-562).
- COBAS INTEGRA Lactate Dehydrogenase - IFCC: contains an in vitro diagnostic reagent system intended for use on COBAS INTEGRA for the quantitative determination of the catalytic activity of LDH (EC 1.1.1.27; L-lactate: NAD oxidoreductase ) in serum and plasma (test LDHI, 0-181).
- COBAS INTEGRA Total Protein - urine and CSF: contains an in vitro diagnostic reagent system intended for use on COBAS INTEGRA for the quantitative determination of the total protein concentration in urine and cerebrospinal fluid (tests TPU, 0-123 and TPC, 0-223).
- COBAS INTEGRA Lactate: contains an in vitro diagnostic reagent system intended for use on COBAS INTEGRA for the quantitative determination of the lactate concentration in plasma and cerebrospinal fluid (tests LACT, 0-22 and LACTC, 0-122).
- COBAS INTEGRA Tobramycin: contains an in vitro diagnostic reagent system intended for use on COBAS INTEGRA for the quantitative determination of tobramycin in serum or heparinized plasma (test TOBR, 0-92).
- COBAS INTEGRA Immunoglobulin A: contains an in vitro diagnostic reagent system intended for use on COBAS INTEGRA for the quantitative determination of the immunological determination of human immunoglobulin A in serum. In addition to the standard application (test IGA, 0-075), the sensitive application (test IGAP, 0-175) is designed for the quantitative determination of low IgA concentrations in e.g. pediatric samples.
- COBAS INTEGRA Immunoglobulin G: contains an in vitro diagnostic reagent system intended for use on COBAS INTEGRA for the quantitative determination of the immunological determination of human immunoglobulin G in serum. In addition to the standard application (test IGG, 0-076), the sensitive application (test IGGP, 0-176) is designed for the quantitative determination of low IgG concentrations in e.g. pediatric samples.
- COBAS INTEGRA Immunoglobulin M: contains an in vitro diagnostic reagent system intended for use on COBAS INTEGRA for the quantitative determination of the immunological determination of human immunoglobulin M in serum. In addition to the standard application (test IGM, 0-077), the sensitive application (test IGMP, 0-177) is designed for the quantitative determination of low IgM concentrations in e.g. pediatric samples.
Product codes
JQB, CFJ, CEK, KHP, LFW, CFN
Device Description
All of the COBAS INTEGRA Reagent Cassettes contained in this submission are intended for use with the COBAS INTEGRA Analyzer. The 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. 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.
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
pediatric (for low IgA, IgG, IgM concentrations)
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)
The document presents tables comparing the technological characteristics and performance (Assay Range, Precision, Accuracy, and Sensitivity for Tobramycin) of the COBAS INTEGRA reagent cassettes with their predicate devices.
Gamma-Glutamyltransferase - IFCC:
- Precision:
- Level 1: Mean 28 U/L, %CV (within run) 1.0, %CV (total) 2.7
- Level 2: Mean 546 U/L, %CV (within run) 1.1, %CV (total) 2.5
- Accuracy: y = 1.27x - 0.9 U/L, r = 0.999, n = 202 vs. COBAS INTEGRA GGT (TRIS)
Lactate Dehydrogenase - IFCC:
- Precision:
- Level 1: Mean 214 U/L, %CV (within run) 0.65, %CV (total) 2.6
- Level 2: Mean 339 U/L, %CV (within run) 0.65, %CV (total) 1.9
- Accuracy: y = 1.07x + 0.4 U/L, r = 0.999, n = 106 vs. COBAS INTEGRA LD (L - P)
Total Protein - urine and CSF:
- Precision (Urine):
- Level 1: Mean 17.4 mg/dL, %CV (total) 8.2
- Level 2: Mean 57.4 mg/dL, %CV (total) 2.9
- Level 3: Mean 107.6 mg/dL, %CV (total) 2.4
- Precision (CSF):
- Level 1: Mean 28.9 mg/dL, %CV (total) 1.3
- Level 2: Mean 951 mg/dL, %CV (total) 0.80
- Accuracy (Urine): y = 0.89x + 0 mg/L, r = 0.992, n = 274 vs. Sigma
Lactate:
- Precision (Control Sera):
- Level 1: Mean 12.6, %CV (within run) 0.92, %CV (total) 1.2
- Level 2: Mean 47.7, %CV (within run) 0.62, %CV (total) 1.1
- Precision (CSF):
- Level 1: Mean 20.7, %CV (within run) 0.90
- Level 2: Mean 74.7, %CV (within run) 0.89
- Accuracy: y=1.00x - 0.1 mmol/L, r = 0.999, n = 224 vs. Boehringer Mannheim 911
Tobramycin:
- Precision:
- Level 1: Mean 1.4 mg/dL, %CV (total) 6.0
- Level 2: Mean 3.5 mg/dL, %CV (total) 4.5
- Level 3: Mean 7.5 mg/dL, %CV (total) 4.0
- Accuracy: y = 0.854 +0.015, r = 0.996, n = 196 vs. Abbott TDX
Immunoglobulin A (modified):
- Precision (standard application):
- Level 1: Mean 2.3 g/L, %CV (within run) 1.4, %CV (total) 2.8
- Level 2: Mean 3.5 g/L, %CV (within run) 0.81, %CV (total) 1.8
- Precision (Pediatric application):
- Level 1: Mean 1.17 mg/dL, %CV (within run) 1.1, %CV (total) 3.0
- Level 2: Mean 3.28 mg/dL, %CV (within run) 0.96, %CV (total) 1.0
- Accuracy (standard application): y = 0.97x -0.05 g/L, r = 0.989, n = 400 vs. Behringer
- Accuracy (pediatric application): y = 1.01x + 0.01 g/L, r = 0.996, n = 204 vs. Behringer
Immunoglobulin G (modified):
- Precision (standard application):
- Level 1: Mean 12.9 g/mL, %CV (within run) 2.0, %CV (total) 2.9
- Level 2: Mean 25.5 g/mL, %CV (within run) 1.4, %CV (total) 1.9
- Precision (Pediatric application):
- Level 1: Mean 7.1 mg/dL, %CV (within run) 0.81, %CV (total) 3.0
- Level 2: Mean 16.9 mg/dL, %CV (within run) 0.83, %CV (total) 1.3
- Accuracy (standard application): y = 1.02x - 0.9 g/L, r = 0.996, n = 244 vs. Behringer
- Accuracy (pediatric application): y = 0.93x + 0.30 g/L, r = 0.986, n = 212 vs. Behringer
Immunoglobulin M (modified):
- Precision (standard application):
- Level 1: Mean 0.6 g/mL, %CV (within run) 2.6, %CV (total) 3.1
- Level 2: Mean 1.9 g/mL, %CV (within run) 2.0, %CV (total) 2.2
- Precision (Pediatric application):
- Level 1: Mean 0.44 mg/dL, %CV (within run) 1.9, %CV (total) 4.9
- Level 2: Mean 1.08 mg/dL, %CV (within run) 1.6, %CV (total) 2.1
- Accuracy (standard application): y = 1.12x - 0.06 g/L, r = 0.994, n = 400 vs. Behringer
- Accuracy (pediatric application): y = 1.17x - 0.03 g/L, r = 0.984, n = 214 vs. Behringer
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Tobramycin:
Sensitivity: 0.04 µg/mL
Predicate Device(s)
K951595, K954992, K853681, K780563, K802668, K860894
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 862.1360 Gamma-glutamyl transpeptidase and isoenzymes test system.
(a)
Identification. A gamma-glutamyl transpeptidase and isoenzymes test system is a device intended to measure the activity of the enzyme gamma-glutamyl transpeptidase (GGTP) in plasma and serum. Gamma-glutamyl transpeptidase and isoenzymes measurements are used in the diagnosis and treatment of liver diseases such as alcoholic cirrhosis and primary and secondary liver tumors.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.
0
JAN 1 3 1997
Image /page/0/Figure/1 description: The image shows the logo for Roche Diagnostic Systems. The logo consists of a black hexagon with the word "Roche" inside, followed by the text "Roche Diagnostic Systems" in bold black letters. Below the company name, it says "A Member of the Roche Group" in a smaller font.
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 as outlined in 21 CFR 807.92 is provided herewith.
L Identification of 510(k) Sponsor:
Roche Diagnostic Systems, Inc. a subsidiary of Hoffmann-La Roche, Inc. Branchburg Township 1080 US Highway 202 Somerville, NJ 08876-3771
510(k) Submission dated November 5, 1996
1
III Device Name
The device name, including both the trade/proprietary name and the classification name are provided in the table below.
| Proprietary Name | Classification
Name | Product Code | CFR Reference
Number |
|----------------------------------|-------------------------------------------------------------|--------------|-------------------------|
| COBAS INTEGRA... | | | |
| Gamma-Glutamyltransferase - IFCC | Gamma-glutamyl transpeptidase
Isoenzymes, Kinetic Method | JQB | 862.1360 |
| Lactate Dehydrogenase - IFCC | Lactate Dehydrogenase, NAD
Reduction / NADH Oxidation | CFJ | 862.1440 |
| Total Protein - urine and CSF | Total Protein, Biuret
(Colorimetric) | CEK | 862.1635 |
| Lactate | Lactic Acid, Enzymatic Method | KHP | 862.1450 |
| Tobramycin | Tobramycin, Fluorescence
Polarization Immunoassay | LFW | 862.3900 |
| Immunoglobulin A | Immunoglobulins (G, A, M),
Nephelometric Method | CFN | 862.1330 |
| Immunoglobulin G | Immunoglobulins (G, A, M),
Nephelometric Method | CFN | 862.1330 |
| Immunoglobulin M | Immunoglobulins (G, A, M),
Nephelometric Method | CFN | 862.1330 |
Identification of the legally marketed device to which the 510(k) sponsor claims III. equivalence:
The following table identifies the legally marketed devices to which Roche Diagnostic Systems, Inc. claims equivalence.
| Product Name | Predicate Product Name | K number | date of
substantial
equivalence |
|----------------------------------|--------------------------------------------------|----------|---------------------------------------|
| COBAS INTEGRA... | | | |
| Gamma-Glutamyltransferase - IFCC | Roche COBAS INTEGRA, GGT (TRIS) | K951595 | 9/8/95 |
| Lactate Dehydrogenase - IFCC | Roche COBAS INTEGRA, LD
(Lactate - Pyruvate) | K954992 | 1/25/96 |
| Total Protein - urine and CSF | SIGMA Diagnostics, Microprotein-PR | K853681 | 10/28/95 |
| Lactate | Boehringer Mannheim, Lactate | K780563 | 4/18/78 |
| Tobramycin | Abbott Diagnostics, TDX / TDX Flex
Tobramycin | K802668 | 11/24/80 |
| Immunoglobulin A | Behring Diagnostics, N and NA Reagents | K860894 | 4/15/86 |
| Immunoglobulin G | Behring Diagnostics, N and NA Reagents | K860894 | 4/15/86 |
| Immunoglobulin M | Behring Diagnostics, N and NA Reagents | K860894 | 4/15/86 |
2
IV. Description of the Device/Statement of Intended Use:
Through this submission it is the intention of Roche to gain clearance of an additional 5 new COBAS INTEGRA Reagent Cassettes and a modified version of 3 previously cleared reagent cassettes. All of the COBAS INTEGRA Reagent Cassettes contained in this submission are intended for use with the COBAS INTEGRA Analyzer.
The new Reagent Cassettes are:
COBAS INTEGRA Gamma- Glutamyltransferase - IFCC: .
contains an in vitro diagnostic reagent system intended for use on COBAS INTEGRA for the quantitative determination of the catalytic activity of GGT, (EC 2.3.2.2, y-glutamyl peptide: amino acid y-glutamyltransferase) in serum and plasma (test GGTI, 0-562).
COBAS INTEGRA Lactate Dehydrogenase - IFCC: .
contains an in vitro diagnostic reagent system intended for use on COBAS INTEGRA for the quantitative determination of the catalytic activity of LDH (EC 1.1.1.27; L-lactate: NAD oxidoreductase ) in serum and plasma (test LDHI, 0-181).
COBAS INTEGRA Total Protein - urine and CSF: . contains an in vitro diagnostic reagent system intended for use on COBAS INTEGRA for the quantitative determination of the total protein concentration in urine and cerebrospinal fluid (tests TPU, 0-123 and TPC, 0-223).
COBAS INTEGRA Lactate: .
contains an in vitro diagnostic reagent system intended for use on COBAS INTEGRA for the quantitative determination of the lactate concentration in plasma and cerebrospinal fluid (tests LACT, 0-22 and LACTC, 0-122).
COBAS INTEGRA Tobramycin: .
contains an in vitro diagnostic reagent system intended for use on COBAS INTEGRA for the quantitative determination of tobramycin in serum or heparinized plasma (test TOBR, 0-92).
The modified Reagent Cassettes are:
● COBAS INTEGRA Immunoglobulin A:
contains an in vitro diagnostic reagent system intended for use on COBAS INTEGRA for the quantitative determination of the immunological determination of human immunoglobulin A in serum. In addition to the standard application (test IGA, 0-075), the sensitive application (test IGAP, 0-175) is designed for the quantitative determination of low IgA concentrations in e.g. pediatric samples.
3
COBAS INTEGRA Immunoglobulin G: .
contains an in vitro diagnostic reagent system intended for use on COBAS INTEGRA for the quantitative determination of the immunological determination of human immunoglobulin G in serum. In addition to the standard application (test IGG, 0-076), the sensitive application (test IGGP, 0-176) is designed for the quantitative determination of low IgG concentrations in e.g. pediatric samples.
- COBAS INTEGRA Immunoglobulin M: .
contains an in vitro diagnostic reagent system intended for use on COBAS INTEGRA for the quantitative determination of the immunological determination of human immunoglobulin M in serum. In addition to the standard application (test IGM, 0-077), the sensitive application (test IGMP, 0-177) is designed for the quantitative determination of low IgM concentrations in e.g. pediatric samples.
The 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. 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.
V. Summary of the technological characteristics of the new device in comparison to those of the predicate.
Tables 1 through 8 in the following section of this summary outline the technological characteristics (methodologies) of the COBAS INTEGRA Reagent Cassettes in comparison to those of legally marketed products.
V. Brief discussion of the clinical and nonclinical tests relied on for a determination of substantial equivalence:
The following tables 1 through 8 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 This information concludes that the performance of these devices are in this chart. essentially equivalent to other legally marketed devices of a similar kind.
4
| COBAS INTEGRA GGT - IFCC | COBAS INTEGRA GGT - (TRIS) | |
|---|---|---|
| Intended Use | quantitative determination of the | |
| catalytic activity of GGT | quantitative determination of the | |
| catalytic activity of GGT | ||
| Sample type | serum and plasma | serum and plasma |
| Methodology | kinetic method - International | |
| Federation of Clinical Chemistry | ||
| (IFCC) | kinetic method - Szasz-Persjun | |
| Reagents | R1: Buffer granulate | |
| R2: L-y-glutamyl-3-carboxy-4- | ||
| nitroanilide granulate with | ||
| preservative | R1: Buffer granulate | |
| R2: L-y-glutamyl-3-carboxy-4- | ||
| nitroanilide granulate with preservative | ||
| Calibrator | Roche Calibrator (human) | Roche Calibrator (human) |
| Controls | Roche Control Serum N and P | |
| (human) | Roche Control Serum N and P (human) | |
| Performance Characteristics: | ||
| Assay Range | 0 - 1,200 U/L | 0 - 700 U/L |
Table 1 - Gamma-Glutamyltransferase IFCC
| Assay Range | 0 - 1,200 U/L
0 - 12,000 U/L with post dilution | 0 - 700 U/L
0 - 2,800 U/L with postdilution |
|-------------------------------------------------------------|----------------------------------------------------------------------------|-----------------------------------------------------|
| Precision:
Mean (U/L)
%CV (within run)
%CV (total) | Level 1 Level 2
28 546
1.0 1.1
2.7 2.5 | Level 1 Level 2
37.9 345
0.67 0.46
1.2 1.4 |
| Accuracy | $y = 1.27x - 0.9$ U/L
r = 0.999 n = 202
vs. COBAS INTEGRA GGT (TRIS) | $y = 1.02x + 0$ U/L
r = 0.998 n = 238 |
$\smile$
5
| COBAS INTEGRA LDH - IFCC | COBAS INTEGRA LDH - (L - P) | |
|---|---|---|
| Intended Use | quantitative determination of the | |
| catalytic activity of LDH | quantitative determination of the | |
| catalytic activity of LDH | ||
| Sample type | serum and plasma | serum |
| Methodology | kinetic method - lactate to pyruvate | |
| International Federation of Clinical | ||
| Chemistry (IFCC) | kinetic method - lactate to pyruvate | |
| Gay, McComb, and Bowers | ||
| Reagents | R1: Substrate | |
| R2: Coenzyme - NADH in TRIS | ||
| buffer with preservatives and | ||
| stabilizer | R1: Substrate | |
| R2: Coenzyme - NAD | ||
| Calibrator | Roche Calibrator (human) | Roche Calibrator (human) |
| Controls | Roche Control Serum N and P | |
| (human) | Roche Control Serum N and P (human) | |
| Performance Characteristics: | ||
| Assay Range | 0 - 1,200 U/L | |
| 0 - 12,000 U/L with post dilution | 0 - 1,000 U/L | |
| 0 - 10,000 U/L with postdilution | ||
| Precision: | ||
| Mean (U/L) | Level 1 Level 2 | |
| 214 | ||
| 339 | Level 1 Level 2 | |
| 141 | ||
| 439 | ||
| %CV (within run) | 0.65 | |
| 0.65 | 1.3 | |
| 0.99 | ||
| %CV (total) | 2.6 | |
| 1.9 | 2.8 | |
| 1.5 | ||
| Accuracy | y = 1.07x + 0.4 U/L | |
| r = 0.999 n = 106 | ||
| vs. COBAS INTEGRA LD (L - P) | y = 0.95x - 14.3 U/L | |
| r = 0.999 n = 190 | ||
| vs. Boehringer Mannheim |
Table 2 - Lactate Dehydrogenase - IFCC
- Station and Canada Career Comments of
.
6
| | COBAS INTEGRA Total
Protein - Urine / CSF | Sigma Diagnostics
Microprotein - PR |
|------------------------------|----------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------|
| Intended Use | quantitative determination of total protein | quantitative determination of total protein |
| Sample type | urine and cerebrospinal fluid | urine and cerebrospinal fluid |
| Methodology | colorimetric method using
pyrogallol-red molybdate complex | colorimetric method using pyrogallol-
red molybdate complex |
| Reagents | R1: Pyrogallol red and sodium
molybdate in buffer with
detergents and stabilizer | 1. Pyrogallol red and sodium
molybdate in buffer with chelating
agent, stabilizer, surfactant and
preservative |
| Calibrator | Roche Calibrator (human) | Sigma Protein Standard Solution |
| Controls | recommended : Biorad
Lyphocheck Urine Controls | Sigma urine and CSF Controls |
| Performance Characteristics: | | |
| Assay Range | 1 - 250 mg/dL
1 - 250 mg/dL with post dilution | 1 - 200 mg/dL |
| Precision (Urine): | Level 1 Level 2 Level 3 | Level 1 Level 2 Level 3 |
| Mean (mg/dL) | 17.4 57.4 107.6 | 7.69 26.96 135.49 |
| %CV (total) | 8.2 2.9 2.4 | 9.37 6.42 2.57 |
| Precision (CSF): | Level 1 Level 2 | Level 1 Level 2 Level 3 |
| Mean (mg/dL) | 28.9 951 | 37.87 69.86 121.25 |
| %CV (total) | 1.3 0.80 | 3.47 2.65 2.29 |
| Accuracy (Urine) | y = 0.89x + 0 mg/L
r = 0.992 n = 274
vs. Sigma | y = 1.005x +0.458
r = 0.997 n = 95
vs. similar commercially available
method |
Table 3 Total Protein - Urine and CSF
7
| Table | 4 - Lactate | |
|---|---|---|
| ------- | -- | ------------- |
..............................................................................................................................................................................
"ﺳﻤﺴﺴﺴﺴ
| | COBAS INTEGRA Lactate | Boehringer Mannheim Lactate -
on Hitachi 911 Analyzer |
|------------------------------|---------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------|
| Intended Use | quantitative determination of
lactate | quantitative determination of lactate |
| Sample type | plasma and cerebrospinal fluid | plasma and cerebrospinal fluid |
| Methodology | colorimetric (LOX/PAP) with lactate
oxidase and 4-aminoantipyrine | colorimetric - lactate to pyruvate
(NAD Reduction/NADH Oxidation) |
| Reagents | R1: Lactate oxidase (microbial) in
TRIS buffer with stabilizer and
preservative | R1: NAD in carbonate buffer with
preservatives
R2: LD (porcine muscle) and ALT
(porcine heart) |
| Calibrator | Roche Calibrator (human) | BM Standard 1 |
| Controls | Roche Control Serum N and P
(human) | Precitrol - N and A Control Serum |
| Performance Characteristics: | | |
| Assay Range | 0 - 180 mmol/L
0 - 1,800 mmol/L with post dilution | Up to 100 mg/dL
Up to 199 mg/dL with postdilution |
| Precision (Control
Sera): | Level 1 Level 2 | Level 1 Level 2 Level 3 |
| Mean (mg/dL) | 12.6 47.7 | 7.7 23.5 55.1 |
| %CV (within run) | 0.92 0.62 | 2.7 1.1 0.7 |
| %CV (total) | 1.2 1.1 | 3.8 1.3 0.9 |
| Precision (CSF): | Level 1 Level 2 | |
| Mean (mg/dL) | 20.7 74.7 | |
| %CV (within run | 0.90 0.89 | |
| Accuracy | $y = 1.00x - 0.1$ mmol/L
$r = 0.999$ n = 224
vs. Boehringer Mannheim 911 | $y = 0.985x - 0.09$
$r = 0.999$ n = 57
vs. Boehringer Mannheim 717 |
8
Table 5 - Tobramycin
|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------
| | COBAS INTEGRA
Tobramycin | Abbott TDX/TDX Flex
Tobramycin |
|------------------------------|----------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------|
| Intended Use | quantitative determination of
tobramycin | quantitative determination of
tobramycin |
| Sample type | serum and heparinized plasma | serum and plasma |
| Methodology | fluorescence polarization | fluorescence polarization |
| Calibrators | 0, 1, 2, 4, 7, 10 µg/mL | 0, 0.5, 1.5, 3.0, 6.0, 10.0 µg/mL |
| Reagents: | R1: Anti-tobramycin monoclonal
antibody (mouse) in buffer
R2: Fluorescein labeled
tobramycin derivative in buffer | R1: Tobramycin Antiserum (sheep) in
buffer
R2: Fluorescein tracer in buffer |
| Performance Characteristics: | | |
| Assay Range | 0.04 - 10 µg/mL | 0.18 - 10.0 µg/mL |
| Precision:
Mean (mg/dL) | Level 1 Level 2 Level 3
1.4 3.5 7.5 | Level 1 Level 2 Level 3
0.98 4.02 8.15 |
| %CV (total) | 6.0 4.5 4.0 | 5.18 4.45 4.62 |
| Accuracy | y = 0.854 +0.015
r = 0.996 n = 196
vs. Abbott TDX | y = 0.934 +0.248 µg/mL
r = 0.951 n = 170
vs. enzyme immunoassay |
| Sensitivity | 0.04 µg/mL | 0.18 µg/mL |
9
| | COBAS INTEGRA IgA
(modified) | COBAS INTEGRA IgA
(currently marketed) | Behringer N and NA
Reagents | | |
|---------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------|-------------------------------|---------------------------|
| Intended Use | quantitative determination
of human IgA, and a
sensitive application for
quantitative determination
of low IgA concentrations
(pediatric) | quantitative determination
of human IgA | quantitative
determination of human
serumproteins | | |
| Sample type | serum | serum | serum, umbilical cord
serum or cerebrospinal
fluid | | |
| Methodology | Immunoturbidimetric | Immunoturbidimetric | Immunoturbidimetric | | |
| Reagents | R1: Anti-IgA T antiserum
(rabbit) specific for human
IgM in phosphate buffer
R2: IgA in diluted serum
(human) with stabilizer | R1: Anti-IgA T antiserum
(rabbit) specific for human
IgM in phosphate buffer
R2: IgA in diluted serum
(human) with stabilizer | 1. Antiserum to human
IgA
2. Phosphate-buffered
saline | | |
| Calibrator | Roche Serumproteins T
Standard | Roche Serumproteins T
Standard | Behringer N Protein
Standard | | |
| Controls | Roche Serumproteins T
Control | Roche Serumproteins T
Control | Behringer N/T Protein
Control Serum (human) | | |
| Performance Characteristics: | | | | | |
| Assay Range | 0.11 - 3.54 g/L
0.04 - 10.6 g/L with rerun | 0.95 - 15.2 g/L
0.32 - 36.5 g/L with rerun | not specified in labeling | | |
| Precision
(standard
application:
Mean (g/mL)
%CV (within run)
%CV (total) | Level 1
2.3
1.4
2.8 | Level 2
3.5
0.81
1.8 | Level 1
2.3
1.4
2.8 | Level 2
3.5
0.81
1.8 | not specified in labeling |
| Precision
(Pediatric
application):
Mean (mg/dL)
%CV (within run)
%CV (total) | Level 1
1.17
1.1
3.0 | Level 2
3.28
0.96
1.0 | not applicable | not specified in labeling | |
| Accuracy
(standard
application) | y = 0.97x -0.05 g/L
r = 0.989 n = 400
vs. Behringer | y = 0.97x -0.05 g/L
r = 0.989 n = 400
vs. Behringer | not specified in labeling | | |
| Accuracy
(pediatric
application) | y = 1.01x + 0.01 g/L
r = 0.996 n = 204
vs. Behringer | not applicable | not specified in labeling | | |
Table 6 - Immunoglobulin A
Диватин-----------------------------------------------------------------------------------------------------------------------------------------------------------------------
10
| | COBAS INTEGRA IgG
(modified) | COBAS INTEGRA IgG
(currently marketed) | Behringer N and NA
Reagents |
|---------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------|
| Intended Use | quantitative determination
of human IgG, and a
sensitive application for
quantitative determination
of low IgG concentrations
(pediatric) | quantitative determination
of human IgG | quantitative
determination of human
serumproteins |
| Sample type | serum | serum | serum, umbilical cord
serum or cerebrospinal
fluid |
| Methodology | Immunoturbidimetric | Immunoturbidimetric | Immunoturbidimetric |
| Reagents | R1: Anti-IgG T antiserum
(rabbit) specific for human
IgM in phosphate buffer
R2: IgG in diluted serum
(human) with stabilizer | R1: Anti-IgG T antiserum
(rabbit) specific for human
IgM in phosphate buffer
R2: IgG in diluted serum
(human) with stabilizer | 1. Antiserum to human
IgG
2. Phosphate-buffered
saline |
| Calibrator | Roche Serumproteins T
Standard | Roche Serumproteins T
Standard | Behringer N Protein
Standard |
| Controls | Roche Serumproteins T
Control | Roche Serumproteins T
Control | Behringer N/T Protein
Control Serum (human) |
| Performance Characteristics: | | | |
| Assay Range | 4.0 - 63.8 g/L
1.0 - 153 g/L with rerun | 4.7 - 75 g/L
1.2 - 180 g/L with rerun | not specified in labeling |
| Precision
(standard
application:
Mean (g/mL)
%CV (within run)
%CV (total) | Level 1
Level 2
12.9
25.5
2.0
1.4
2.9
1.9 | Level 1
Level 2
12.9
25.5
2.0
1.4
2.9
1.9 | not specified in labeling |
| Precision
(Pediatric
application):
Mean (mg/dL)
%CV (within run)
%CV (total) | Level 1
Level 2
7.1
16.9
0.81
0.83
3.0
1.3 | not applicable | not specified in labeling |
| Accuracy
(standard
application) | y = 1.02x - 0.9 g/L
r = 0.996 n = 244
vs. Behringer | y = 1.02x - 0.9 g/L
r = 0.996 n = 244
vs. Behringer | not specified in labeling |
| Accuracy
(pediatric
application) | y = 0.93x + 0.30 g/L
r = 0.986 n = 212
vs. Behringer | not applicable | not specified in labeling |
| | COBAS INTEGRA IgA
(modified) | COBAS INTEGRA IgA
(currently marketed) | Behringer N and NA
Reagents |
| Intended Use | quantitative determination
of human IgM, and a
sensitive application for
quantitative determination
of low IgM concentrations
(pediatric) | quantitative determination
of human IgM | quantitative
determination of human
serumproteins |
| Sample type | serum | serum | serum, umbilical cord
serum or cerebrospinal
fluid |
| Methodology | Immunoturbidimetric | Immunoturbidimetric | Immunoturbidimetric |
| Reagents | R1: Anti-IgM T antiserum
(rabbit) specific for human
IgM in phosphate buffer
R2: IgM in diluted serum
(human) with stabilizer | R1: Anti-IgM T antiserum
(rabbit) specific for human
IgM in phosphate buffer
R2: IgM in diluted serum
(human) with stabilizer | 1. Antiserum to human
IgM
2. Phosphate-buffered
saline |
| Calibrator | Roche Serumproteins T
Standard | Roche Serumproteins T
Standard | Behringer N Protein
Standard |
| Controls | Roche Serumproteins T
Control | Roche Serumproteins T
Control | Behringer N/T Protein
Control Serum (human) |
| Performance Characteristics: | | | |
| Assay Range | 0.31 - 5.0 g/L
0.11 - 12.1 g/L with rerun | 0.47 - 7.5 g/L
0.16 - 18 g/L with rerun | not specified in labeling |
| Precision
(standard
application: | Level 1 Level 2 | Level 1 Level 2 | not specified in labeling |
| Mean (g/mL) | 0.6 1.9 | 0.6 1.9 | |
| %CV (within run) | 2.6 2.0 | 2.6 2.0 | |
| %CV (total) | 3.1 2.2 | 3.1 2.2 | |
| Precision
(Pediatric
application): | Level 1 Level 2 | not applicable | not specified in labeling |
| Mean (mg/dL) | 0.44 1.08 | | |
| %CV (within run) | 1.9 1.6 | | |
| %CV (total) | 4.9 2.1 | | |
| Accuracy
(standard
application) | y = 1.12x - 0.06 g/L
r = 0.994 n = 400
vs. Behringer | y = 1.12x - 0.06 g/L
r = 0.994 n = 400
vs. Behringer | not specified in labeling |
| Accuracy
(pediatric
application) | y = 1.17x - 0.03 g/L
r = 0.984 n = 214
vs. Behringer | not applicable | not specified in labeling |
Table 7 - Immunoglobulin G
:
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11