(82 days)
The cassette COBAS INTEGRA x-1-Antitrypsin (AAT) contains an in vitro diagnostic reagent system intended for use on COBAS INTEGRA 700 for the quantitative immunological determination of human x-1-antitrypsin in serum and plasma. The measurements aid in the diagnosis of several conditions including juvenile and adult cirrhosis of the liver. In addition, a-1-antitrypsin deficiency has been associated with pulmonary emphysema.
The cassette COBAS INTEGRA Immunoglobulin A (IGA/IGAP) contains an in vitro diagnostic reagent system intended for use on COBAS INTEGRA 700 for the quantitative immunological determination of human immunoglobulin A in serum and plasma. addition to the standard application (IGA), the sensitive application (IGAP) is designed for the quantitative determination of low IgA concentrations in e.g. pediatric samples. Measurement of this immunoglobulin aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.
The cassette COBAS INTEGRA Immunoglobulin M (IGM/IGMP) contains an in vitro diagnostic reagent system intended for use on COBAS INTEGRA 700 for the quantitative immunological determination of human immunoglobulin M in serum and plasma. In addition to the standard application (IGM), the sensitive application (IGMP) is designed for the quantitative determination of low IgM concentrations in e.g. pediatric samples. Measurement of this immunoglobulin aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.
The cassette COBAS INTEGRA Immunoglobulin G (Turbidimetric) (IGGT/IGGTC) contains an in vitro diagnostic reagent system intended for use on COBAS INTEGRA 700 for the quantitative immunological determination of human immunoglobulin G in serum, plasma (IGGT) and cerebrospinal fluid (IGGTC). Measurement of this immunoglobulin aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.
The COBAS INTEGRA test applications contained in this submission are intended for use with the COBAS INTEGRA Analyzer, which is also known as the COBAS INTEGRA 700. The COBAS INTEGRA Analyzer and COBAS INTEGRA Reagent cassettes together provide an integrated system for in vitro diagnostic testing. The COBAS INTEGRA Analyzer utilizes three measuring principles, i.e., absorbance, fluorescence polarization and ion-selective electrodes. The analyzer has a throughput of up to 600 tests per hour with STAT samples prioritized and tested immediately. Random sample access, robotics and a user interface optimize time management and streamline workflow. The COBAS INTEGRA can store up to 68 COBAS INTEGRA Reagent Cassettes on board, 24 hours a day at 2-8°C. The COBAS INTEGRA Reagent Cassettes are compact and preparation-free with the added convenience of long term on-board stability. Barcode readers are used to identify newly loaded reagent cassettes, samples for patient identification, and rack inserts and to read calibration and control data from the cassette label. COBAS INTEGRA tests include chemistry, drugs of abuse, immunology, ion selective electrodes, therapeutic drug monitoring, and hematology reagents.
Here's a breakdown of the acceptance criteria and study information for the Roche COBAS® INTEGRA Reagent Cassettes for α-1-Antitrypsin (AAT), Immunoglobulin A (IGA/IGAP), and Immunoglobulin M (IGM/IGMP), based on the provided text:
Important Note: The provided document is a 510(k) Summary. This type of summary focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific pre-defined acceptance criteria in the same way a novel device might. The "acceptance criteria" here are inferred from the performance characteristics presented to show equivalence. The studies are primarily comparative studies against predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
Device: Roche COBAS® INTEGRA Reagent Cassettes (AAT, IGA/IGAP, IGM/IGMP)
| Performance Characteristic | Acceptance Criteria (inferred from predicate/previous version) | Reported Device Performance (Modified COBAS INTEGRA) | Predicate Device Performance (where available) |
|---|---|---|---|
| α-1-Antitrypsin (AAT) | |||
| Accuracy (Corr. Coeff. (r)) | Must be comparable to predicate (e.g., K972640: 0.967 / K954992: 0.930) | 0.995 (vs. BM) | Predicate K972640: 0.967; Cleared K954992: 0.930 |
| Linear Regression | Must be comparable to predicate | 1.30x - 0.31 g/L | Predicate K972640: 0.993x + 9.9 mg/dL; Cleared K954992: 0.90x + 0.06 g/L |
| Immunoglobulin A (IGA/IGAP) | |||
| Precision (IGA) | |||
| Level 1 (Mean ~2.0-2.3 g/L) | Within-run CV comparable to predicate/cleared (e.g., BM: 0.9%, Cleared: 1.4%) | 2.0% | Predicate BM: 0.9%; Cleared K954457: 1.4% |
| Level 2 (Mean ~3.5-6.2 g/L) | Within-run CV comparable to predicate/cleared (e.g., BM: 0.8%, Cleared: 0.81%) | 0.97% | Predicate BM: 0.8%; Cleared K954457: 0.81% |
| Total CV Level 1 | Total CV comparable to predicate/cleared (e.g., BM: 2.2%, Cleared: 2.8%) | 2.3% | Predicate BM: 2.2%; Cleared K954457: 2.8% |
| Total CV Level 2 | Total CV comparable to predicate/cleared (e.g., BM: 1.8%, Cleared: 1.8%) | 1.2% | Predicate BM: 1.8%; Cleared K954457: 1.8% |
| Accuracy (Corr. Coeff. (r)) | Must be comparable to predicate (e.g., BM: 0.99 / Cleared: 0.989) | 0.994 (vs. BM/Hitachi) | Predicate BM: 0.99; Cleared K954457: 0.989 |
| Linear Regression | Must be comparable to predicate | 1.023x - 0.214 g/L | Predicate BM: 0.83x + 20.6 mg/dL; Cleared K954457: 0.97x - 0.05 g/L |
| Assay Range | Must be comparable or improved | 0.45 - 7.3 g/L (std); 0.15 - 98.6 g/L (rerun) | Cleared K954457: 0.79 - 12.6 g/L (std); 0.27 - 30.2 g/L (rerun) |
| Sensitivity | Must be comparable or improved | 0.45 g/L | Cleared K954457: 0.79 g/L |
| Immunoglobulin M (IGM/IGMP) | |||
| Precision (IGM) | |||
| Level 1 (Mean ~0.55-0.6 g/L) | Within-run CV comparable to predicate/cleared (e.g., BM: 0.79%, Cleared: 2.6%) | 2.4% | Predicate BM: 0.79%; Cleared K954457: 2.6% |
| Level 2 (Mean ~1.9-2.0 g/L) | Within-run CV comparable to predicate/cleared (e.g., BM: 0.8%, Cleared: 2.0%) | 1.6% | Predicate BM: 0.8%; Cleared K954457: 2.0% |
| Total CV Level 1 | Total CV comparable to predicate/cleared (e.g., BM: 3.7%, Cleared: 3.1%) | 3.2% | Predicate BM: 3.7%; Cleared K954457: 3.1% |
| Total CV Level 2 | Total CV comparable to predicate/cleared (e.g., BM: 2.4%, Cleared: 2.2%) | 1.9% | Predicate BM: 2.4%; Cleared K954457: 2.2% |
| Accuracy (Corr. Coeff. (r)) | Must be comparable to predicate (e.g., BM: 0.979 / Cleared: 0.994) | 0.994 (vs. BM/Hitachi) | Predicate BM: 0.979; Cleared K954457: 0.994 |
| Linear Regression | Must be comparable to predicate | 1.293x + 0.341 g/L | Predicate BM: 0.81x + 5.9 mg/dL; Cleared K954457: 1.12x - 0.06 g/L |
| Assay Range | Must be comparable or improved | 0.16 - 5.18 g/L (std); 0.05 - 24.35 g/L (rerun) | Cleared K954457: 0.31 - 5.0 g/L (std); 0.11 - 12.1 g/L (rerun) |
| Sensitivity | Must be comparable or improved | 0.16 g/L | Cleared K954457: 0.31 g/L |
2. Sample Sizes Used for the Test Set and Data Provenance
- α-1-Antitrypsin (AAT):
- Sample Size: 288
- Data Provenance: Not explicitly stated but implied to be clinical samples (serum/plasma). Origin (e.g., country) and retrospective/prospective nature are not specified.
- Immunoglobulin A (IGA/IGAP):
- Sample Size: 584
- Data Provenance: Not explicitly stated but implied to be clinical samples (serum/plasma). Origin (e.g., country) and retrospective/prospective nature are not specified.
- Immunoglobulin M (IGM/IGMP):
- Sample Size: 556
- Data Provenance: Not explicitly stated but implied to be clinical samples (serum/plasma). Origin (e.g., country) and retrospective/prospective nature are not specified.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This device is an in vitro diagnostic reagent, and the 'ground truth' is established by comparative measurements against predicate devices using laboratory methods, not human expert interpretation of images or clinical cases. The comparison is against established laboratory testing methods.
4. Adjudication Method for the Test Set
Not applicable. The 'test set' here consists of biological samples measured by the device and compared to results from predicate devices/methods. There is no human adjudication process described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. MRMC studies are typically for imaging devices or AI tools that assist human readers in interpretation. This is an IVD reagent, and the effectiveness is evaluated through analytical performance characteristics like accuracy, precision, and linearity when compared to established methods.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, in a sense. The studies summarized are standalone performance evaluations of the reagent cassette on the COBAS INTEGRA Analyzer. The results are generated by the automated system, without "human-in-the-loop" needing to interpret the primary measurement, although human operators load samples and review results. The comparison is between the modified reagent's performance and that of other established laboratory methods (predicate devices).
7. The Type of Ground Truth Used
The ground truth used for these studies is comparative measurement data from legally marketed predicate devices and established laboratory methods. Specifically:
- AAT: Comparison against Boehringer Mannheim α-1-Antitrypsin Reagent (K972640) and Cleared COBAS INTEGRA α-1-Antitrypsin (K954992). The "vs. BM" implies using the Boehringer Mannheim method as a reference.
- IGA/IGAP: Comparison against Boehringer Mannheim Immunoglobulin A Reagent (K955907) and Cleared COBAS INTEGRA Immunoglobulin A (K954457). The "vs. BM/Hitachi" indicates comparison with these laboratory systems.
- IGM/IGMP: Comparison against Boehringer Mannheim Immunoglobulin M Reagent (K955908) and Cleared COBAS INTEGRA Immunoglobulin M (K954457). The "vs. BM/Hitachi" indicates comparison with these laboratory systems.
8. The Sample Size for the Training Set
Not applicable. These are reagent cassettes used with an existing analyzer. There is no mention of machine learning or AI models with "training sets" in the context of this 510(k) submission. The development and optimization of the reagent formulations and assay parameters would be part of a different internal R&D process, not typically described as a "training set" in this context.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" in the context of this device and submission. The "ground truth" for evaluating the performance of these reagents is established through established analytical chemistry and immunology principles, validated against reference materials, and benchmarked against predicate diagnostic assays.
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Image /page/0/Picture/0 description: The image shows the word "Roche" written in black font inside of a hexagon. The hexagon is also black. The word "Roche" is centered inside of the hexagon.
SEP 2 8 1998
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.
The assigned 510(k) number is: 4982387-
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 July 7, 1998
Rita Smith Contact: Senior Regulatory Affairs Associate Phone: (908) 253-7545 (908) 253-7547 Fax:
Branchburg Township 1080 U.S. Highway 202 t
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Roche Diagnostic Systems, Inc. Somerville, New Jersey 08876 July 1998
II. Device Name:
The device name, including both the trade/proprietary name and the classification name are provided in the table below.
| Product Name | ClassificationName | ProductCode | CFRNumber andRegulatory Class |
|---|---|---|---|
| COBAS INTEGRAα-1-Antitrypsin Reagent Cassette(AAT) | α-1-antitrypsin, antigen,antiserum, control | DEM | 866.5130Class II |
| Roche COBAS INTEGRAImmunoglobulin A Reagent Cassette nephelometric methods(IGA/IGAP) | Immunoglobulins. (G,A,M) | CFN | 866.5510Class II |
| Roche COBAS INTEGRAImmunoglobulin M Reagent Cassette nephelometric methods(IGM/IGMP) | Immunoglobulins. (G,A,M) | CFN | 866.5510Class II |
| Roche COBAS INTEGRAImmunoglobulin G Reagent Cassette nephelometric methods(IGGT/IGGTC) | Immunoglobulins, (G,A,M) | CFN | 866.5510Class II |
Table I
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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 ProductName | DatePredicateCleared | Predicate510(k)Number |
|---|---|---|---|
| COBAS INTEGRAα-1-Antitrypsin Reagent Cassette(AAT) | Boehringer Mannheim α-1-Antitrypsin Reagent | 1/9/98 | K972640 |
| Roche COBAS INTEGRAImmunoglobulin A Reagent Cassette(IGA/IGAP) | Boehringer MannheimImmunoglobulin A Reagent | 2/9/96 | K955907 |
| Roche COBAS INTEGRAImmunoglobulin M Reagent Cassette(IGM/IGMP) | Boehringer MannheimImmunoglobulin M Reagent | 2/9/96 | K955908 |
| Roche COBAS INTEGRAImmunoglobulin G Reagent Cassette(IGGT/IGGTC) | Boehringer MannheimImmunoglobulin G Reagent andBehring DiagnosticsImmunoglobulin G Reagent | 2/5/80 | K800119 |
Table 2
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Roche Diagnostic Systems, Inc. Somerville, New Jersey 08876 July 1998
IV. Description of the Device/Statement of Intended Use:
The COBAS INTEGRA test applications contained in this submission are intended for use with the COBAS INTEGRA Analyzer, which is also known as the COBAS INTEGRA 700. The COBAS INTEGRA Analyzer and COBAS INTEGRA Reagent cassettes together provide an integrated system for in vitro diagnostic testing. The COBAS INTEGRA Analyzer along with 108 Roche COBAS INTEGRA Reagent Cassettes were previously cleared on September 8, 1995 (K951595); January 25, 1996 (K954992); July 23, 1996 (K961824); October 31, 1996 (K963292); January 21, 1997 (K964457); August 12, 1997 (K972250); and May 21, 1998 (K974695).
The COBAS INTEGRA Analyzer utilizes three measuring principles, i.e., absorbance, fluorescence polarization and ion-selective electrodes. The analyzer has a throughput of up to 600 tests per hour with STAT samples prioritized and tested immediately. Random sample access, robotics and a user interface optimize time management and streamline workflow. The COBAS INTEGRA can store up to 68 COBAS INTEGRA Reagent Cassettes on board, 24 hours a day at 2-8°C. The COBAS INTEGRA Reagent Cassettes are compact and preparation-free with the added convenience of long term on-board stability. Barcode readers are used to identify newly loaded reagent cassettes, samples for patient identification, and rack inserts and to read calibration and control data from the cassette label. COBAS INTEGRA tests include chemistry, drugs of abuse, immunology, ion selective electrodes, therapeutic drug monitoring, and hematology reagents. For additional information on the COBAS INTEGRA Analyzer and its constituent modules, please refer to the Operator's Manual in Volumes 1 through 2, pages 92-703, of the original 510(k) submission (K951595).
Through this submission, it is the intention of Roche to gain clearance for modifications to four currently marketed reagent cassettes: Roche COBAS INTEGRA x-1-Antitrypsin Reagent Cassette (AAT); Roche COBAS INTEGRA Immunoglobulin A Reagent Cassette (IGA/IGAP); Roche COBAS INTEGRA Immunoglobulin M Reagent Cassette (IGM/IGMP); and Roche COBAS INTEGRA Immunoglobulin G Reagent Cassette (IGGT/IGGTC).
V. Summary of the technological characteristics of the new device in comparison to those of the predicate.
Tables 3-7 outline the technological characteristics (methodologies) of the COBAS INTEGRA Reagents in comparison to those of legally marketed predicate products.
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Brief discussion of the clinical and nonclinical tests relied on for a determination of VI. substantial equivalence:
Tables 3-7 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.
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COBAS INTEGRA α-1-Antitrypsin (AAT)
The cassette COBAS INTEGRA cx-1-Antitrypsin (AAT) contains an in vitro diagnostic reagent system intended for use on COBAS INTEGRA 700 for the quantitative immunological determination of human a-1-antitrypsin in serum and plasma. The measurements aid in the diagnosis of several conditions including juvenile and adult cirrhosis of the liver. In addition, a-1-antitrypsin deficiency has been associated with pulmonary emphysema.
| COBAS INTEGRAα-1-Antitrypsin(AAT)(modified) | COBAS INTEGRAα-1-Antitrypsin(AAT)(cleared) K954992 | BMTina-Quantα-1-antitrypsin(K972640) | |
|---|---|---|---|
| Intended Use | quantitative immunologicaldetermination of α-1-antitrypsin inserum and plasma | quantitative immunologicaldetermination of α-1-antitrypsin in serum | quantitative immunologicaldetermination of α-1-antitrypsinin serum and plasma |
| Performance Characteristics: | |||
| Accuracy: | serum/plasma vs. BM | serum | vs. Behring Nepholometric |
| Sample size (n) | 288 | 284 | 123 |
| Corr. Coefficient (r) | 0.995 | 0.930 | 0.967 |
| Linear regression | $1.30x - 0.31$ g/L | $0.90x + 0.06$ g/L | $0.993x + 9.9$ mg/dL |
Table 3 - COBAS INTEGRA a-1-Antitrypsin (AAT)
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COBAS INTEGRA Immunoglobulin A (IGA/IGAP)
The cassette COBAS INTEGRA Immunoglobulin A (IGA/IGAP) contains an in vitro diagnostic reagent system intended for use on COBAS INTEGRA 700 for the quantitative immunological determination of human immunoglobulin A in serum and plasma. In addition to the standard application (IGA), the sensitive application (IGAP) is designed for the quantitative determination of low IgA concentrations in e.g. pediatric samples. Measurement of this immunoglobulin aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.
| COBAS INTEGRAImmunoglobulin A(IGA/IGAP)(modified) | COBAS INTEGRAImmunoglobulin A(IGA/IGAP)(cleared) K954457 | BMTina-QuantImmunoglobulin A Assay(K955907) | |||||
|---|---|---|---|---|---|---|---|
| Intended Use | quantitative immunologicaldetermination of humanimmunoglobulin A in serumand plasma, and sensitiveapplication for the quantitativedetermination of low IgAconcentration in e.g. pediatricsamples | quantitative immunologicaldetermination of humanimmunoglobulin A inserum, and sensitiveapplication for thequantitative determinationof low IgA concentration ine.g. pediatric samples | quantitative determination of IgA inserum and plasma on automatedclinical chemistry analyzers. | ||||
| Affected Parameters: | |||||||
| Predilution Factor | 21 | 41 | |||||
| Postdilution Factor | 13.5 | 2.4 | |||||
| Sample Volume | 5 uL | 9 uL | |||||
| R1 + water volume | 90 uL + 10 uL | 90 uL | |||||
| R2 + water volume | 5 uL + 5 uL | 9 uL | |||||
| First Calc. Cycle | T0 | 19 | |||||
| IGA Performance Characteristics: | |||||||
| Precision: | Level 1 | Level 2 | Level 1 | Level 2 | Level 1 | Level 2 | Level 3 |
| Mean | 2.0 (g/L) | 6.2 (g/L) | 2.3 (g/L) | 3.5 (g/L) | 118.8 (mg/dL) | 227.7 (mg/dL) | 268.5 (mg/dL) |
| CV (%) within-run | 2.0 | 0.97 | 1.4 | 0.81 | 0.9 | 0.8 | 1.0 |
| CV (%) total | 2.3 | 1.2 | 2.8 | 1.8 | 2.2 | 1.8 | 2.1 |
| Accuracy: | vs. BM/Hitachi | vs. Behring Nepholometric | |||||
| Sample size (n) | 584 | 400 | 36 | ||||
| Corr. Coefficient (r) | 0.994 | 0.989 | 0.99 | ||||
| Linear regression | 1.023 x - 0.214 g/L | 0.97 x - 0.05 g/L | 0.83x + 20.6 mg/dL | ||||
| Assay Range | 0.45 - 7.3 g/L0.15 - 98.6 g/L (with rerun) | 0.79 - 12.6 g/L0.27 - 30.2 g/L (with rerun) | 50 mg/dL- highest calibrator20 - 6000 mg/dL (with rerun) | ||||
| Sensitivity | 0.45 g/L | 0.79 g/L | 20 mg/dL |
Table 4 - COBAS INTEGRA Immunoglobulin A (IGA/IGAP)
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COBAS INTEGRA Immunoglobulin M (IGM/IGMP)
The cassette COBAS INTEGRA Immunoglobulin M (IGM/IGMP) contains an in vitro diagnostic reagent system intended for use on COBAS INTEGRA 700 for the quantitative immunological determination of human immunoglobulin M in serum and plasma. In addition to the standard application (IGM), the sensitive application (IGMP) is designed for the quantitative determination of low IgM concentrations in e.g. pediatric samples. Measurement of this immunoglobulin aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.
| COBAS INTEGRAImmunoglobulin M(IGM/IGMP)(modified) | COBAS INTEGRAImmunoglobulin M(IGM/IGMP)(cleared) K954457 | BM Tina-QuantImmunoglobulin MAssay(K955908) | ||||||
|---|---|---|---|---|---|---|---|---|
| Intended Use | quantitative immunologicaldetermination of humanimmunoglobulin M in serumand plasma, and sensitiveapplication for thequantitative determination oflow IgM concentration in e.g.pediatric samples | quantitative immunologicaldetermination of humanimmunoglobulin M inserum, and sensitiveapplication for thequantitative determination oflow IgM concentration ine.g. pediatric samples | For the quantitative determinationof IgM in serum and plasma onautomated clinical chemistryanalyzers | |||||
| Affected Parameters: | ||||||||
| Calibrator dilution ratio | 1:3, 1:6, 1:12, 1:24, 1:48, 1:96 | 1:6, 1:12, 1:24, 1:48, 1:96 | ||||||
| Predilution Factor | 1:96 | 41 | ||||||
| Postdilution Factor | 21 | 2.4 | ||||||
| Sample Volume | 4.7 | 26 uL | ||||||
| R1 + water volume | 13 uL | 65 uL + 10 uL | ||||||
| R2 | 65 uL + 20 uL | 16 uL | ||||||
| First Calc. Cycle | 13 uL | 19 | ||||||
| T0 | ||||||||
| IGM Performance Characteristics: | ||||||||
| Precision: | Level 1 | Level 2 | Level 1 | Level 2 | Level 1 | Level 2 | Level 3 | |
| Mean | 0.55 (g/L) | 2.0 (g/L) | 0.6 (g/L) | 1.9 (g/L) | 55.4 (mg/dL) | 93.9 (mg/dL) | 134.8 (mg/dL) | |
| CV (%) within-run | 2.4 | 1.6 | 2.6 | 2.0 | 0.79 | 0.8 | 0.7 | |
| CV (%) total | 3.2 | 1.9 | 3.1 | 2.2 | 3.7 | 2.4 | 2.0 | |
| Accuracy: | vs. BM/Hitachi | vs. Behring Nepholometric | ||||||
| Sample size (n) | 556 | 400 | 39 | |||||
| Corr. Coefficient (r) | 0.994 | 0.994 | 0.979 | |||||
| Linear regression | $1.293 x + 0.341$ g/L | $1.12 x - 0.06$ g/L | $0.81x + 5.9$ mg/dL | |||||
| Assay Range | 0.16 - 5.18 g/L0.05 - 24.35 g/L (with rerun) | 0.31 - 5.0 g/L0.11 - 12.1 g/L (with rerun) | 25 mg/dL - highest calibrator10 - 4000 mg/dL (with rerun) | |||||
| Sensitivity | 0.16 g/L | 0.31 g/L | 10 mg/dL |
Table 5 - COBAS INTEGRA Immunoglobulin M (IGM/IGMP)
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Image /page/8/Picture/2 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name arranged in a circular fashion around a central emblem. The emblem consists of a stylized caduceus-like symbol, with three figures representing health and human services.
SEP 28 1998
Ms. Rita Smith Senior Regulatory Affairs Associate Roche Diagnostic System, Inc. a subsidiary of Hoffmann-La Roche, Inc. Branchburg Township 1080 U.S. Hiqhway 202 Somerville, New Jersey 08876-3771
Re: K982382 Roche COBAS® INTEGRA Reagent Cassettes Trade Name: Regulatory Class: II Product Code: DEM, CFN, DAH, CZP, DEW Dated: July 7, 1998 Received: July 8, 1998
Dear Ms. Smith:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval) , it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
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Page 2
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a leqally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Steven Putman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1 of 2
510(k) Number (if known) K982382
Roche COBAS INTEGRA &-1-Antitrypsin Reagent Cassette (AAT) Device Name: Art. No. 07 5092 1
Roche COBAS INTEGRA Immunoglobulin A Reagent Cassette (IGA/IGAP) Art. No. 07 3775 5
Roche COBAS INTEGRA Immunoglobulin M Reagent Cassette (IGM/IGMP) Art. No. 07 3777 1
Roche COBAS INTEGRA Immunoglobulin G Reagent Cassette (IGGT/IGGTC) Art. No. 07 6663 1
Indications for Use:
The cassette COBAS INTEGRA x-1-Antitrypsin (AAT) contains an in vitro diagnostic reagent system intended for use on COBAS INTEGRA 700 for the quantitative immunological determination of human x-1-antitrypsin in serum and plasma. The measurements aid in the diagnosis of several conditions including juvenile and adult cirrhosis of the liver. In addition, a-1-antitrypsin deficiency has been associated with pulmonary emphysema.
The cassette COBAS INTEGRA Immunoglobulin A (IGA/IGAP) contains an in vitro diagnostic reagent system intended for use on COBAS INTEGRA 700 for the quantitative immunological determination of human immunoglobulin A in serum and plasma. addition to the standard application (IGA), the sensitive application (IGAP) is designed for the quantitative determination of low IgA concentrations in e.g. pediatric samples. Measurement of this immunoglobulin aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.
The cassette COBAS INTEGRA Immunoglobulin M (IGM/IGMP) contains an in vitro diagnostic reagent system intended for use on COBAS INTEGRA 700 for the quantitative immunological determination of human immunoglobulin M in serum and plasma. In addition to the standard application (IGM), the sensitive application (IGMP) is designed for the quantitative determination of low IgM concentrations in e.g. pediatric samples. Measurement of this immunoglobulin aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.
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The cassette COBAS INTEGRA Immunoglobulin G (Turbidimetric) (IGGT/IGGTC) contains an in vitro diagnostic reagent system intended for use on COBAS INTEGRA 700 for the quantitative immunological determination of human immunoglobulin G in serum, plasma (IGGT) and cerebrospinal fluid (IGGTC). Measurement of this immunoglobulin aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.
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Concurrence of CDRH/ Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of Clinical Laboratory Devices | |
| 510(k) Number |
| Prescription Use(Per 21 CFR 801.109) | OR | Over-The-Counter Use(Optional Format 1-2-96) |
|---|---|---|
| ------------------------------------------ | ---- | -------------------------------------------------- |
§ 866.5510 Immunoglobulins A, G, M, D, and E immunological test system.
(a)
Identification. An immunoglobulins A, G, M, D, and E immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the immunoglobulins A, G, M, D, an E (serum antibodies) in serum. Measurement of these immunoglobulins aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.(b)
Classification. Class II (performance standards).