(20 days)
No
The description details a colorimetric assay based on chemical reactions and photometric measurement, with no mention of AI or ML.
No
This device is an in vitro diagnostic reagent system used for quantitative determination of albumin, which aids in diagnosis and treatment, but it does not directly provide therapy.
Yes
The "Intended Use / Indications for Use" section states that the device is "an in vitro diagnostic reagent system" and that "Albumin measurements are used in the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys." This directly indicates its role in diagnosis.
No
The device description clearly states it is a "reagent system" and a "colorimetric assay," which are physical components used in a laboratory setting, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that the reagent system is "intended for use on COBAS Integra systems for the quantitative determination of the albumin concentration in human serum and plasma." This is a classic definition of an in vitro diagnostic test, as it analyzes biological samples (serum and plasma) outside of the body to provide diagnostic information.
- Device Description: The description details a "colorimetric assay" that measures a substance (albumin) in a biological sample. This is consistent with the nature of IVD devices.
- Purpose: The intended use also mentions that albumin measurements are "used in the diagnosis and treatment of numerous diseases." This further confirms its diagnostic purpose.
N/A
Intended Use / Indications for Use
The cassette COBAS Integra Albumin Gen.2 (ALB2) contains an in vitro diagnostic reagent system intended for use on COBAS Integra systems for the quantitative determination of the albumin concentration in human serum and plasma. Albumin measurements are used in the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys.
Product codes
CIX
Device Description
The COBAS Integra Albumin Gen.2 is a colorimetric assay for the determination of albumin concentration in serum or plasma. At a pH value of 4.1, albumin displays a sufficiently cationic character to be able to bind with bromcresol green (BCG) to form a blue-green complex. The color intensity is directly proportional to the albumin concentration and can be determined photometrically.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 862.1035 Albumin test system.
(a)
Identification. An albumin test system is a device intended to measure the albumin concentration in serum and plasma. Albumin measurements are used in the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys.(b)
Classification. Class II.
0
OCT 16 2003
510(k) Summary - COBAS Integra Albumin Gen.2
| Introduction | According to the requirements of 21 CFR 807.92, the following information
provides sufficient detail to understand the basis for a determination of
substantial equivalence |
|----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter
name, address,
contact | Roche Diagnostics Corporation
9115 Hague Rd
Indianapolis IN 46250
(317) 521-3831 |
| | Contact person: Sherri L. Coenen |
| | Date prepared: September 24, 2003 |
| Device Name | Proprietary name: Roche Diagnostics COBAS Integra Albumin Gen.2 |
| | Common name: Albumin Assay |
| | Classification name: Albumin test system |
| Device
description | The COBAS Integra Albumin Gen.2 is a colorimetric assay for the
determination of albumin concentration in serum or plasma. At a pH value of
4.1, albumin displays a sufficiently cationic character to be able to bind with
bromcresol green (BCG) to form a blue-green complex. The color intensity is
directly proportional to the albumin concentration and can be determined
photometrically. |
| Intended use | The cassette COBAS Integra Albumin Gen.2 (ALB2) contains an in vitro
diagnostic reagent system intended for use on COBAS Integra systems for the
quantitative determination of the albumin concentration in human serum and
plasma. |
| Predicate
Device | We claim substantial equivalence to the currently marketed COBAS Integra
Albumin Assay. (K951595). |
: ·
1
510(k) Summary - COBAS Integra Creatinine plus ver.2,
continued
The following table describes the similarities and differences between the Reagent Summary COBAS Integra Albumin Gen.2 and the predicate device.
| Topic | COBAS Integra Albumin
(K951595) | COBAS Integra Albumin Gen.2
(Modified Device) |
|--------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The cassette COBAS Integra
Albumin (ALB) contains an in vitro
diagnostic reagent system intended
for use on COBAS Integra systems
for the quantitative determination of
the albumin concentration in serum
and plasma. | The cassette COBAS Integra
Albumin Gen.2 (ALB2) contains an
in vitro diagnostic reagent system
intended for use on COBAS Integra
systems for the quantitative
determination of the albumin
concentration in serum and plasma. |
| Method | BCG colorimetric assay with
endpoint method | Same |
| Sample type | Serum
Heparin or EDTA plasma | Same |
| Measuring
range | 0.08 - 60 g/L | 2 - 60 g/L |
| Expected
values | Adults (18-60 yrs): 3.5 - 5.0 g/dL
Adults (> 60 yrs): 3.4 - 4.8 g/dL
Newborn: 2.8 - 4.4 g/dL
Children (4 days - 14 yrs): 3.8 - 5.4
g/dL
Children (14 - 18 years): 3.2 - 4.5
g/dL | Adults: 3.4 - 4.8 g/dL
Newborn: 2.8 - 4.4 g/dL
Children (4 days - 14 yrs): 3.8 - 5.4
g/dL
Children (14 - 18 years): 3.2 - 4.5
g/dL |
.. .
25
2
Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal are three stylized human profiles facing to the right, with flowing lines extending from the bottom of the profiles.
OCT 1 6 2003
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Sherri L. Coenen Regulatory Affairs Consultant Regulatory Submissions, Centralized Diagnostics Roche Diagnostics Corporation 9115 Hague Road P.O. Box 50457 Indianapolis, IN 46250-0457
Re: K033009
Trade/Device Name: COBAS Integra Albumin Gen.2 Regulation Number: 21 CFR 862.1035 Regulation Name: Albumin test system Regulatory Class: Class II Product Code: CIX Dated: September 24, 2003 Received: September 26, 2003
Dear Ms. Coenen:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
3
Page 2 -
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer 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 Sutman
Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
4
Indications for Use Statement
510(k) Number (if known): N/A K033009
Device Name: COBAS Integra Albumin Gen.2
Indications For Use:
The cassette COBAS Integra Albumin Gen.2 (ALB2) contains an in vitro diagnostic reagent system intended for use on COBAS Integra systems for the quantitative determination of the albumin concentration in human serum and plasma. Albumin measurements are used in the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | ||
|---|---|---|
| Prescription Use | ||
| (Per 21 CFR 801.109) | Over-The-Counter Use | |
| (Optional Format 1-2-96) |
Carol C Benson for Jean Cooper, DVM
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
| 510(k) | K033009 | 22 |
|---|---|---|
| -------- | --------- | ---- |