(191 days)
No
The description details a standard immunoturbidimetric assay for quantitative determination of ceruloplasmin, with no mention of AI or ML in the intended use, device description, or any other section.
No
The device is an in vitro diagnostic reagent system used for quantitative determination of ceruloplasmin to aid in diagnosis, not for treating a condition.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that "Measurements of Ceruloplasmin aid in the diagnosis of copper metabolism disorders." The "Device Description" also repeats this statement, confirming its diagnostic aid function.
No
The device description clearly states it is an "in vitro diagnostic reagent system" and a "cassette," which are physical components, not software. It is intended for use on "COBAS INTEGRA SYSTEMS" and "Roche/Hitachi cobas c systems," which are hardware platforms.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The document explicitly states "In vitro test for the quantitative immunological determination of ceruloplasmin in human serum and plasma". This clearly indicates the device is used to test samples outside of the body (in vitro) to diagnose or monitor a medical condition.
- Device Description: The description refers to the device as an "in vitro diagnostic reagent system".
- Purpose: The stated purpose is to "aid in the diagnosis of copper metabolism disorders" by measuring ceruloplasmin in human serum and plasma. This aligns with the definition of an IVD, which is used to provide information for diagnosis, monitoring, or screening.
N/A
Intended Use / Indications for Use
COBAS INTEGRA Ceruloplasmin: Ceruloplasmin
In vitro test for the quantitative immunological determination of ceruloplasmin in human serum and plasma on COBAS INTEGRA systems.
Measurements of Ceruloplasmin aid in the diagnosis of copper metabolism disorders.
Roche/Hitachi cobas c systems:
In vitro test for the quantitative determination of ceruloplasmin in human serum and plasma on Roche/Hitachi cobas c systems.
Measurements of Ceruloplasmin aid in the diagnosis of copper metabolism disorders.
Product codes
CHN
Device Description
The COBAS INTEGRA Ceruloplasmin cassette (CERU) contains an in vitro diagnostic reagent system intended for use on COBAS INTEGRA SYSTEMS for the quantitative immunological determination of human ceruloplasmin in serum and plasma. The calibrator and control were cleared via K954992.
Measurements of ceruloplasmin aid in the diagnosis of copper metabolism disorders.
The test principle is an immunoturbidimetric assay. The calibrator is Serumproteins T Standard and the recommended control material is the Serumproteins T Control.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The document provides comparative performance characteristics between the subject device and the predicate device.
Measuring range: COBAS INTEGRA Ceruloplasmin: 0.06-1.26 g/L, Predicate device: 0.06-1.3 g/L
Lower Detection Limit: COBAS INTEGRA Ceruloplasmin: 0.017 g/L, Predicate device: 0.02 g/L
Precision:
COBAS INTEGRA Ceruloplasmin:
Within run total CV%: 3.88% @ 0.2 g/L, 2.66% @ 0.35 g/L
Predicate device:
Within run total CV%: 1.0% @ 0.27 g/L, 1.4% @ 0.34 g/L, 1.6% @ 0.62 g/L
Linearity: COBAS INTEGRA Ceruloplasmin: 0.06-1.26 g/L, Predicate device: 0.06-0.69 g/L
Method comparison: y = COBAS INTEGRA Ceruloplasmin, x = DAKOCytomation Anti Human Ceruloplasmin. Passing-Bablok results: y = 1.0x - 0.0 g/L; r =0.987
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 866.5210 Ceruloplasmin immunological test system.
(a)
Identification. A ceruloplasmin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the ceruloplasmin (copper-transporting serum protein) in serum, other body fluids, or tissues. Measurements of ceruloplasmin aid in the diagnosis of copper metabolism disorders.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 866.9.
0
510(k) Summary – COBAS INTEGRA Ceruloplasmin KO 62114
According to the requirements of 21 CFR 807.92, the following information Introduction provides sufficient detail to understand the basis for a determination of substantial equivalence
Due to a misinterpretation caused in part by an error on the FDA Purpose classification database available on line, which had erroneously listed Ceruloplasmin as exempt until June 2005, this test system was erroneously considered by us to be exempt during its original application to the COBAS INTEGRA and Roche Hitachi families of analyzers. It was erroneously listed by us as exempt in the reagent lists accompanying the FDA-cleared premarket notification submissions for the COBAS INTEGRA 800 and Roche Hitachi 917 analyzers. The COBAS INTEGRA family of analyzers was cleared under K951595 and the Roche/Hitachi family of analyzers under K953239/A005.
In order to correct this error, Roche now submits a traditional 510(k) featuring performance data on the Integra 700 analyzer. The assay has already been applied to all Integra family members and to the Roche/Hitachi family of analyzers using the Application Validation Protocol submitted as part of this 510(k).
Roche Diagnostics Submitter name, address, 9115 Hague Rd contact Indianapolis IN 46250 (317) 521-3723
Contact person: Corina Harper
Date prepared: Jul 17, 2006
Device Name Proprietary name: COBAS INTEGRA Ceruloplasmin
Common name: Ceruloplasmin
Classification name: Ceruloplasmin immunological test system
1
| Device
Description | The COBAS INTEGRA Ceruloplasmin cassette (CERU) contains an in vitro
diagnostic reagent system intended for use on COBAS INTEGRA SYSTEMS
for the quantitative immunological determination of human ceruloplasmin in
serum and plasma. The calibrator and control were cleared via K954992. |
|----------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Measurements of ceruloplasmin aid in the diagnosis of copper metabolism
disorders. |
| | The test principle is an immunoturbidimetric assay. The calibrator is
Serumproteins T Standard and the recommended control material is the
Serumproteins T Control. |
| Intended use | The COBAS INTEGRA Ceruloplasmin cassette (CERU) contains an in vitro
diagnostic reagent system intended for use on COBAS INTEGRA SYSTEMS
for the quantitative immunological determination of human ceruloplasmin in
serum and plasma (test CERU3, 0-666). |
| Predicate
Device | We claim substantial equivalence to the DakoCytomation assay for
Polyclonal Rabbit Anti-Human Ceruloplasmin cleared as K812486. |
| Substantial
equivalency -
Similarities | The table below indicates the similarities between the COBAS INTEGRA
Ceruloplasmin test and its predicate device (Polyclonal Rabbit Anti-Human
Ceruloplasmin cleared as K812486). |
:
:
| Feature | Predicate device: Polyclonal
Rabbit Anti-Human
Ceruloplasmin (K812486) | COBAS INTEGRA
Ceruloplasmin |
|-----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| General | | |
| Intended Use/
Indications for
Use | Polyclonal Rabbit Anti-Human
Ceruloplasmin is intended for the
quantitative determination of
Ceruloplasmin in human sample
material by turbidimetry and
nephelometry. | The COBAS INTEGRA
Ceruloplasmin cassette (CERU)
contains an in vitro diagnostic
reagent system intended for use
COBAS INTEGRA SYSTEMS for
the quantitative immunological
determination of human
ceruloplasmin in serum and plasma
(test CERU3, 0-666). |
| Specimen type | Serum, plasma | Same |
| Test principle | | |
| Reference
method | turbidimetry and nephelometry | turbidimetry |
| Reagent information | | |
2
| Stability - shelf
life and on-board | 2-8 °C until expiration date
Stability of prediluted antibody: 28
days at 2-8 °C
On board stability: 28 days 2-8 °C
until expiration date | 2-8 °C until expiration date
COBAS INTEGRA 400/400+
On board in use 8 weeks at 10 to
15° C
COBAS INTEGRA 700/800
On board in use 8 weeks at 8°C |
|----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Calibrator | Human Serum Protein Calibrator
Interval: each lot or 28 days | Serum Proteins T Standard
Interval: each lot |
| Quality control | Human Serum Protein Low and
High | Serum Proteins T Control
Interval: 24 hrs recommended |
| Traceability | Information not available. | Standardized against
IFCC/BCR/CAP reference
preparation CRM 470 (RPPHS
91/0619) for 14 serum proteins. |
| Performance characteristics | | |
| Measuring range | 0.06-1.3 g/L | 0.06-1.26 g/L |
| Lower Detection
Limit | 0.02 g/L | 0.017 g/L |
| Expected values | 0.2-0.6 g/L | Same |
The table below indicates the similarities between the COBAS INTEGRA Substantial equivalency – Ceruloplasmin test and its predicate device (DakoCytomation assay for Differences Polyclonal Rabbit Anti-Human Ceruloplasmin cleared as K812486). 1
·
| Feature | Predicate device: Polyclonal
Rabbit Anti-Human
Ceruloplasmin (K812486) | COBAS INTEGRA
Ceruloplasmin |
|-----------------------------|---------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Reagent information | | |
| R1 | Purified immunoglobulin fraction of
rabbit antiserum provided in liquid.
In 0.1 mol/L NaCl, 15 mmol/L
NaN3 | R1: Accelerator
Polyethylene glycol (PEG) 50 g/L,
in phosphate buffer stabilized with
0.09% sodium azide in vial A
(liquid) |
| R2 | | |
| | | R2=SR: |
| | | Anti-ceruloplasmin T antiserum
(rabbit) specific for human
ceruloplasmin >0.42 g/L in
phosphate buffer stabilized with
0.09% sodium azide in vial C
(liquid) |
| Instrument | COBAS MIRA, Hitachi and other
instruments | COBAS Integra family of
analyzers, Roche/Hitachi family
(including cobas c6000 series) |
| Performance characteristics | | |
| Precision | Within run total CV% | Within run total CV%: |
| | 1.0% @ 0.27 g/L | 3.88% @ 0.2 g/L |
| | 1.4% @ 0.34 g/L | 2.66% @ 0.35 g/L |
| | 1.6% @ 0.62 g/L | |
| Linearity | 0.06-0.69 g/L | 0.06-1.26 g/L |
| Endogenous
interferences | Hemolysis no interferences up to 10
g/L | Hemolysis: no significant
interferences |
| | Icterus no interferences up to 600
mg/L | Icterus: no significant interferences |
| | Triglycerides no interferences up to
25 g/L | Lipemia: no significant
interferences |
| | Intralipid at 10 g/L | Rheumatoid factors: no significant
interferences up to 400 IU/mL |
| Exogenous
Interferences | | Gammopathy, in particular IgM,
may cause unreliable results in rare
cases |
| Method
comparison | y = COBAS INTEGRA Ceruloplasmin
x = DAKOCytomation Anti Human Ceruloplasmin | |
| | Passing-Bablok results: y = $1.0x - 0.0$ g/L; r =0.987 | |
3
Proposed Labeling
Proposed labeling sufficient to describe the device, its intended use and the directions for use can be found in Section V. We believe the proposed version of the device labeling presented contains all of the technical information required per 21 CFR 809.10.
4
| Validation and
Design Control | Development activities were conducted under appropriate design control
procedures and the overall product specifications were met. The Declaration
of Conformity with Design Controls and Results of Risk Analysis are
provided in Section 5.1. Analytical Performance. |
|----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Confidentiality | Roche Diagnostics Corporation requests that the FDA not disclose the nature
or existence of this submission until the substantial equivalence decision has
been reached. |
| Closing | Therefore, we trust the information provided in this Traditional 510(k) will
support a decision of substantial equivalence of the COBAS INTEGRA
Ceruloplasmin test system to the predicate. |
| | If you have any questions or require further information, please do not
hesitate to contact this office. |
| | • Phone: (317) 521-3831
• FAX: (317) 521-2324
• email: corina.harper@roche.com |
:
:
5
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, which is a symbol of medicine, with three lines representing the three branches of government. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the caduceus.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Roche Diagnostics Corporation. c/o Ms. Corina Harper Regulatory Affairs Consultant 9115 Hague Road Indianapolis, IN 46250
JAN 3 1 2007
Re: K062114
Trade/Device Name: COBAS INTEGRA Ceruloplasmin Model 2055953 Regulation Number: 21 CFR 866.5210 Regulation Name: Ceruloplasmin Immunological Test System Regulatory Class: Class II Product Code: CHN Dated: January 10, 2007 Received: January 11, 2007
Dear Ms. Harper:
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 the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The
6
Page 2 –
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 (240) 276-0450. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Touh R. Beckerf
Robert L. Becker, Jr., M.D. Ph.D. Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
7
Indications for Use
KO 62114 510(k) Number (if known):
COBAS INTEGRA Ceruloplasmin: Ceruloplasmin
Indications For Use:
COBAS INTEGRA:
In vitro test for the quantitative immunological determination of ceruloplasmin in human serum and plasma on COBAS INTEGRA systems.
Measurements of Ceruloplasmin aid in the diagnosis of copper metabolism disorders.
Roche/Hitachi cobas c systems:
In vitro test for the quantitative determination of ceruloplasmin in human serum and plasma on Roche/Hitachi cobas c systems.
Measurements of Ceruloplasmin aid in the diagnosis of copper metabolism disorders.
Prescription Use XXX (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Page 1 of 1
Mana M Chan
Division Sign-Off
Office of In Vitro Diagnostic
Device Evaluation and Safety
Ko62114