(82 days)
No
The summary describes a standard in vitro diagnostic system using immunological methods and an automated analyzer. There is no mention of AI or ML in the intended use, device description, or performance studies.
No
The device is an in vitro diagnostic reagent system used for quantitative immunological determination of certain proteins in serum and plasma, aiding in the diagnosis of conditions, not for treating them.
Yes
The "Intended Use / Indications for Use" section explicitly states that the reagent systems are "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..." and similarly for Immunoglobulin A, M, and G, all of which "aid in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents." This language directly indicates its use in diagnosing conditions.
No
The device description clearly states it is an integrated system consisting of the COBAS INTEGRA Analyzer (hardware) and COBAS INTEGRA Reagent Cassettes (reagents), not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states that the cassettes contain "in vitro diagnostic reagent system" and are "intended for use on COBAS INTEGRA 700 for the quantitative immunological determination of human... in serum and plasma." It also mentions that the measurements "aid in the diagnosis of several conditions."
The "Device Description" further reinforces this by stating that the COBAS INTEGRA Analyzer and Reagent cassettes together provide an "integrated system for in vitro diagnostic testing."
These statements clearly indicate that the device is designed to be used outside of the body to examine specimens (serum, plasma, cerebrospinal fluid) for diagnostic purposes.
N/A
Intended Use / 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.
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.
Product codes (comma separated list FDA assigned to the subject device)
DEM, CFN
Device Description
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.
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).
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
Juvenile and adult for α-1-Antitrypsin. Pediatric samples for Immunoglobulin A and M.
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)
Clinical and nonclinical studies were performed using the COBAS INTEGRA Reagent Cassettes.
For α-1-Antitrypsin (AAT):
Accuracy: serum/plasma vs. BM, Sample size (n) = 288, Corr. Coefficient (r) = 0.995, Linear regression = 1.30x - 0.31 g/L.
For Immunoglobulin A (IGA/IGAP):
Precision:
Level 1: Mean = 2.0 (g/L), CV (%) within-run = 2.0, CV (%) total = 2.3
Level 2: Mean = 6.2 (g/L), CV (%) within-run = 0.97, CV (%) total = 1.2
Accuracy: vs. BM/Hitachi, Sample size (n) = 584, Corr. Coefficient (r) = 0.994, Linear regression = 1.023 x - 0.214 g/L.
Assay Range: 0.45 - 7.3 g/L (0.15 - 98.6 g/L with rerun).
For Immunoglobulin M (IGM/IGMP):
Precision:
Level 1: Mean = 0.55 (g/L), CV (%) within-run = 2.4, CV (%) total = 3.2
Level 2: Mean = 2.0 (g/L), CV (%) within-run = 1.6, CV (%) total = 1.9
Accuracy: vs. BM/Hitachi, Sample size (n) = 556, Corr. Coefficient (r) = 0.994, Linear regression = 1.293 x + 0.341 g/L.
Assay Range: 0.16 - 5.18 g/L (0.05 - 24.35 g/L with rerun).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Sensitivity for Immunoglobulin A: 0.45 g/L
Sensitivity for Immunoglobulin M: 0.16 g/L
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.
K972640, K955907, K955908, K800119
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.
K951595, K954992, K961824, K963292, K964457, K972250, K974695
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
§ 866.5510 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).
0
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
1
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 | Classification
Name | Product
Code | CFR
Number and
Regulatory Class |
|------------------------------------------------------------------------------------------------|-------------------------------------------------|-----------------|---------------------------------------|
| COBAS INTEGRA
α-1-Antitrypsin Reagent Cassette
(AAT) | α-1-antitrypsin, antigen,
antiserum, control | DEM | 866.5130
Class II |
| Roche COBAS INTEGRA
Immunoglobulin A Reagent Cassette nephelometric methods
(IGA/IGAP) | Immunoglobulins. (G,A,M) | CFN | 866.5510
Class II |
| Roche COBAS INTEGRA
Immunoglobulin M Reagent Cassette nephelometric methods
(IGM/IGMP) | Immunoglobulins. (G,A,M) | CFN | 866.5510
Class II |
| Roche COBAS INTEGRA
Immunoglobulin G Reagent Cassette nephelometric methods
(IGGT/IGGTC) | Immunoglobulins, (G,A,M) | CFN | 866.5510
Class II |
Table I
2
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 | Date
Predicate
Cleared | Predicate
510(k)
Number |
|--------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------|------------------------------|-------------------------------|
| COBAS INTEGRA
α-1-Antitrypsin Reagent Cassette
(AAT) | Boehringer Mannheim α-1-
Antitrypsin Reagent | 1/9/98 | K972640 |
| Roche COBAS INTEGRA
Immunoglobulin A Reagent Cassette
(IGA/IGAP) | Boehringer Mannheim
Immunoglobulin A Reagent | 2/9/96 | K955907 |
| Roche COBAS INTEGRA
Immunoglobulin M Reagent Cassette
(IGM/IGMP) | Boehringer Mannheim
Immunoglobulin M Reagent | 2/9/96 | K955908 |
| Roche COBAS INTEGRA
Immunoglobulin G Reagent Cassette
(IGGT/IGGTC) | Boehringer Mannheim
Immunoglobulin G Reagent and
Behring Diagnostics
Immunoglobulin G Reagent | 2/5/80 | K800119 |
Table 2
3
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.
4
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.
5
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 INTEGRA
α-1-Antitrypsin
(AAT)
(modified) | COBAS INTEGRA
α-1-Antitrypsin
(AAT)
(cleared) K954992 | BM
Tina-Quant
α-1-antitrypsin
(K972640) |
|------------------------------|---------------------------------------------------------------------------------------|-----------------------------------------------------------------------------|---------------------------------------------------------------------------------------|
| Intended Use | quantitative immunological
determination of α-1-antitrypsin in
serum and plasma | quantitative immunological
determination of α-1-
antitrypsin in serum | quantitative immunological
determination of α-1-antitrypsin
in 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)
6
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 INTEGRA
Immunoglobulin A
(IGA/IGAP)
(modified) | | COBAS INTEGRA
Immunoglobulin A
(IGA/IGAP)
(cleared) K954457 | | BM
Tina-Quant
Immunoglobulin A Assay
(K955907) | | |
|----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|--------------------------------------------------------------------------------------------------------|---------------|---------------|
| Intended Use | quantitative immunological
determination of human
immunoglobulin A in serum
and plasma, and sensitive
application for the quantitative
determination of low IgA
concentration in e.g. pediatric
samples | | quantitative immunological
determination of human
immunoglobulin A in
serum, and sensitive
application for the
quantitative determination
of low IgA concentration in
e.g. pediatric samples | | quantitative determination of IgA in
serum and plasma on automated
clinical 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/L
0.15 - 98.6 g/L (with rerun) | | 0.79 - 12.6 g/L
0.27 - 30.2 g/L (with rerun) | | 50 mg/dL- highest calibrator
20 - 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)
7
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 INTEGRA
Immunoglobulin M
(IGM/IGMP)
(modified) | | COBAS INTEGRA
Immunoglobulin M
(IGM/IGMP)
(cleared) K954457 | | BM Tina-Quant
Immunoglobulin M
Assay
(K955908) | | |
|----------------------------------|--|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|------------------------------------------------------------------------------------------------------------------|--------------|---------------|
| Intended Use | | quantitative immunological
determination of human
immunoglobulin M in serum
and plasma, and sensitive
application for the
quantitative determination of
low IgM concentration in e.g.
pediatric samples | | quantitative immunological
determination of human
immunoglobulin M in
serum, and sensitive
application for the
quantitative determination of
low IgM concentration in
e.g. pediatric samples | | For the quantitative determination
of IgM in serum and plasma on
automated clinical chemistry
analyzers | | |
| 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/L
0.05 - 24.35 g/L (with rerun) | | 0.31 - 5.0 g/L
0.11 - 12.1 g/L (with rerun) | | 25 mg/dL - highest calibrator
10 - 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)
8
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
9
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
10
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.
11
Page 2 of 2
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.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
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) |
| ------------------------------------------ | ---- | -------------------------------------------------- |
|---|