(106 days)
Not Found
No
The device description and performance studies describe a standard turbidimetric immunoassay for CRP, with no mention of AI/ML components or related concepts.
No
This device is an in vitro diagnostic test for the quantitative determination of C-reactive protein, which aids in evaluating injury to body tissues, rather than treating or preventing a disease.
Yes
The device quantifies C-reactive protein (CRP), and "Measurements of C-reactive protein aids in evaluation of the amount of injury to body tissues," which is a diagnostic purpose.
No
The device description clearly indicates a "particle enhanced turbidimetric assay" and mentions "latex particle coated with monoclonal anti-CRP antibodies," which are physical components of an in vitro diagnostic test, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The description explicitly states "In vitro test for the quantitative immunological determination of C-reactive protein in human serum and plasma". This clearly indicates the device is intended for use outside of the body to examine specimens from the human body.
- Device Description: The description details a "particle enhanced turbidimetric assay" that uses "human serum and plasma" and measures the agglutination of latex particles with antibodies. This is a typical description of an in vitro diagnostic test.
- Performance Studies: The document includes details about method comparison and precision studies, which are standard performance evaluations for IVD devices.
The information provided aligns perfectly with the definition and characteristics of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
In vitro test for the quantitative immunological determination of C-reactive protein in human serum and plasma on COBAS INTEGRA systems.
In vitro test for the quantitative determination of C-reactive protein in human serum and plasma on Roche/Hitachi cobas c systems.
Measurements of C-reactive protein aids in evaluation of the amount of injury to body tissues.
Product codes (comma separated list FDA assigned to the subject device)
DCN
Device Description
The C-Reactive Protein (Latex) assay is a particle enhanced turbidimetric assay. Human CRP agglutinates with latex particle coated with monoclonal anti-CRP antibodies. The precipitate is determined turbidimetrically at 552 nm (546 nm on cobas c 501 and c 311 analyzers).
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)
Precision
Level 1, 6.2 mg/L
CV within-run, 1.8%
CV Total, 2.9%
Level 2, 142 mg/L
CV within-run, 1.5%
CV Total, 2.7%
Method Comparison
COBAS Integra 700 CRP Latex (with CRP T Standard) versus COBAS Integra 700 CRP Latex (with Cfas Protein)
n=150
r=0.999
Lin. Regression, y = 0.996x - 0.60 mg/L
P/B Regression, y = 0.992x - 0.16 mg/L
Values ranged from 0.62 to 362 mg/L
Lipemia (L-index) Interference
COBAS INTEGRA 400/400 plus analyzers:
No significant interference up to an L index of 1500 in the lower concentration range (3 mg/L or 28.6 nmol/L).
No significant interference up to an L index of 623 in the higher concentration range (80 mg/L or 762 nmol/L).
COBAS INTEGRA 700/800 analyzers:
No significant interference up to an L index of 1094 in the lower concentration range (3 mg/L or 28.6 nmol/L).
No significant interference up to an L index of 797 in the higher concentration range (80 mg/L or 762 nmol/L).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Lower detection limit: 1.00 mg/L*
- Performance has not changed. The specification is now stated as the claim
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.
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.
Not Found
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
§ 866.5270 C-reactive protein immunological test system.
(a)
Identification. A C-reactive protein immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the C-reactive protein in serum and other body fluids. Measurement of C-reactive protein aids in evaluation of the amount of injury to body tissues.(b)
Classification. Class II (performance standards).
0
MAR – 6 2008
510(k) Summary -- C-Reactive Protein (Latex)
| 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
9115 Hague Rd
Indianapolis IN 46250
(317) 521-7637 |
| | Contact person: Kerwin Kaufman |
| | Date prepared: November 21, 2007 |
| Submission
Purpose | Roche Diagnostics hereby submits this Special 510(k): Device Modification
to provide notification of modifications to our C-Reactive Protein (Latex)
assay. This assay was originally cleared for use in K981897 on the COBAS
Integra 700 (analyzer cleared in K951595). Submission history for additional
applications to the COBAS Integra family and to Roche/Hitachi cobas c
systems are summarized in the following Submission History section. |
| | Since the K981897 filing, several modifications to the C-Reactive Protein
(Latex) application on the COBAS Integra platform include: |
| | • change of calibrator and controls, |
| | • validation of the high end of the measuring range of the assay up to 200
mg/L, and |
| | • more specific Lipemia interference (L-Index) data provided based on
testing with Intralipid instead of triglycerides. |
| | The Limitations-interference section of the COBAS Integra labeling was also
modified to include information about HAMA, monoclonal gammopathy,
and additional testing of a common drug panel. This information is not a
device modification but was provided for more safe and effective use of the
assay. |
| | A further device modification was validated in C-Reactive Protein (Latex)
applications to the Roche/Hitachi cobas c 501 and cobas c 311:
• The high end of the measuring range was validated up to 250 mg/L |
| | Continued on next page |
| Submission
History | Applications of the K981897 CRP Latex modified reagent were applied to
additional analyzers within the COBAS Integra family including Integra 400-
800, 400 Plus and cobas c 111, as well as Roche/Hitachi family cobas c 501
and c 311 analyzers via Letters to File or Internal Documentation per the
Reagent Replacement policy:
■ Integra 400, K951595/A003
■ Integra 800, K951595/A008
■ Integra 400 plus, K951595/A009
■ cobas c 111, Internal Documentation, K981897/A003
■ cobas c 501, Internal Documentation, K060373/A001 (referencing
K981897)
■ cobas c 311, Internal Documentation, K981897/A005 |
| Device Name | Proprietary name: C-Reactive Protein (Latex)
Common name: C-Reactive Protein
Classification name: C-reactive protein immunological test system |
| Establishment
Registration | The establishment registration number for Roche Diagnostics GmbH
Penzberg is 9610126. |
| Classification | The FDA has classified the C-reactive protein immunological test system in
Class II. |
:
1
510(k) Summary – C-Reactive Protein (Latex), Continued
| Panel | Classification
Number | Classification
Name | Regulation
Citation |
|---------------|--------------------------|----------------------------------------------------|------------------------|
| 82 Immunology | DCN | C-reactive protein
immunological test
system | 21 CFR 866.5270 |
2
510(k) Summary – C-Reactive Protein (Latex), Continued
:
| Device
Description | The C-Reactive Protein (Latex) assay is a particle enhanced turbidimetric
assay. Human CRP agglutinates with latex particle coated with monoclonal
anti-CRP antibodies. The precipitate is determined turbidimetrically at 552
nm (546 nm on cobas c 501 and c 311 analyzers). |
|----------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended use | In vitro test for the quantitative immunological determination of C-reactive
protein in human serum and plasma on COBAS INTEGRA systems.
In vitro test for the quantitative determination of C-reactive protein in human |
| Predicate
Device | We claim substantial equivalence to the COBAS INTEGRA C-Reactive
Protein (Latex) cleared as K981897. |
| Substantial
equivalency –
Similarities | The table below indicates the similarities between the modified C-Reactive
Protein (Latex) test and its predicate device (original COBAS INTEGRA C-
Reactive Protein (Latex), K981897). |
| Feature | Predicate: COBAS INTEGRA C-
Reactive Protein (Latex) (K981897) | Modified device: C-Reactive
Protein (Latex) |
|-------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| General | | |
| Intended Use | The cassette COBAS INTEGRA C-
Reactive Protein (Latex), (CRPLX)
contains an in vitro diagnostic reagent
system intended for use on COBAS
INTEGRA 700 for the quantitative
immunological determination of
human C-reactive protein in serum
and plasma. | In vitro test for the quantitative
immunological determination of C-
reactive protein in human serum and
plasma on COBAS INTEGRA
systems.
In vitro test for the quantitative
determination of C-reactive protein
in human serum and plasma on
Roche/Hitachi cobas c systems. |
| Indications for
Use | Measurements of C-reactive protein
aids in evaluation of the amount of
injury to body tissues. | Same |
| Feature | Predicate: COBAS INTEGRA C- Reactive Protein (Latex) (K981897) | Modified device: C-Reactive Protein (Latex) |
| Specimen type | Serum and Plasma. Acceptable
anticoagulants include heparin,
EDTA, fluoride and citrate. | Same |
| Instrument
platform | Integra 700 analyzer. | Integra family including Integra 700,
800, 400, 400 plus, and cobas c111.
Also Roche/Hitachi family of cobas
c systems including cobas c501 and
cobas c311. |
| Test principle | | |
| Determination
of C-reactive
protein | Particle enhanced turbidimetric assay.
Human CRP agglutinates with latex
particle coated with monoclonal anti-
CRP antibodies. The precipitate is
determined turbidimetrically at 552
nm. | Same
Determined turbidimetrically at 546
nm on Roche/Hitachi cobas c
systems |
| Reagent information | | |
| Antibody | Mouse monoclonal anti-CRP
antibodies | Same |
| Traceability | Traceable to the IFCC/BCR/CAP
reference preparation CRM 470
(RPPHS 91/0619) for 14 serum
proteins | Same |
| R1 | TRIS buffer with bovine serum
albumin and immunoglobulins
(mouse) stabilized with 0.09% sodium
azide (liquid) | Same |
| R2 = SR | Latex particles coated with anti-CRP
(mouse) in glycine buffer stabilized
with 0.09% sodium azide (liquid) | Same |
| Reagent
stability | 2-8 °C until expiration date
On-board: 12 weeks | Same
Note: On-board stability on cobas c
111, 5 weeks |
| Feature | Predicate: COBAS INTEGRA C-
Reactive Protein (Latex) (K981897) | Modified device: C-Reactive
Protein (Latex) |
| Performance characteristics | | |
| Precision | Level 1, 6.2 mg/L
CV within-run, 1.8%
CV Total, 2.9%
Level 2, 142 mg/L
CV within-run, 1.5%
CV Total, 2.7% | Same |
| Lower detection
limit | 0.25 mg/L | 1.00 mg/L*
- Performance has not changed.
The specification is now stated as
the claim |
| Method
Comparison | COBAS Integra 700 CRP Latex (with
CRP T Standard) versus COBAS Integra
700 with non-latex CRP (K951595):
n=244
r=0.993
$Lin. Regression, y = 1.07x - 6.2 mg/L$
$P/B Regression, y = 1.00x - 2.7 mg/L$
Values ranged from 0.62 to 421 mg/L | COBAS Integra 700 CRP Latex (with
CRP T Standard) versus COBAS
Integra 700 CRP Latex (with Cfas
Protein)
n=150
r=0.999
$Lin. Regression, y = 0.996x - 0.60 mg/L$
$P/B Regression, y = 0.992x - 0.16 mg/L$
Values ranged from 0.62 to 362 mg/L |
Continued on next page
.
3
Substantial equivalency -- Similarities (continued)
、
4
510(k) Summary -- C-Reactive Protein (Latex), Continued
:
Substantial equivalency – Similarities (continued)
5
510(k) Summary -- C-Reactive Protein (Latex), Continued
The table below indicates the differences between the modified C-Reactive Substantial equivalency -Protein (Latex) test and its predicate device (original COBAS INTEGRA C-Differences Reactive Protein (Latex), K981897).
| Feature | Predicate: COBAS INTEGRA C-
Reactive Protein (Latex) (K981897) | Modified device: C-Reactive
Protein (Latex) |
|--------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | |
| Calibrator | CRP T Standard (K954992) | Cfas Proteins (K012393) |
| Quality control | CRP T Control (K954992)
CRP T Control N (K003400) | CRP T Control N
Precinorm Protein (K012371)
Precipath Protein (K012371) |
| Lipemia
(L-index)
Interference | Lipemia: Triglyceride levels higher
than 7.5 g/L decrease the apparent
CRP value significantly. Turbid
samples exceeding 0.1 Absorbance are
recognized by the "High Activity"
check. Correct results can be obtained
after post-dilution. | Lipemia: (Intralipid)
COBAS INTEGRA 400/400 plus analyzers:
No significant interference up to an L index
of 1500 in the lower concentration range
(3 mg/L or 28.6 nmol/L).
No significant interference up to an L index
of 623 in the higher concentration range
(80 mg/L or 762 nmol/L).
COBAS INTEGRA 700/800 analyzers:
No significant interference up to an L index
of 1094 in the lower concentration range
(3 mg/L or 28.6 nmol/L).
No significant interference up to an L index
of 797 in the higher concentration range
(80 mg/L or 762 nmol/L).
There is poor correlation between the
L index (corresponds to turbidity) and
triglycerides concentration.
Turbid samples exceeding 0.1 Absorbance
are recognized by the "High Activity"
check. Correct results can be obtained after
postdilution. |
6
| Feature | Predicate: COBAS INTEGRA C-
Reactive Protein (Latex) (K981897) | Modified device: C-Reactive
Protein (Latex) |
|--------------------|-----------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Measuring
Range | 0-160 mg/L
0-1600 mg/L with postdilution
Postdilution factor of 10
recommended | Integra 700, 800, 400, 400 plus, and
cobas c 111:
1-200 mg/L
Determine samples having higher
concentrations via the rerun
function. Dilution of samples via
the rerun function is a 1:10 dilution.
Results from samples diluted by the
rerun function are automatically
multiplied by a factor of 10.
cobas c 501 / c 311:
1-250 mg/L
Determine samples having higher
concentrations via the rerun
function. Dilution of samples via
the rerun function is a 1:3 dilution.
Results from samples diluted by the
rerun function are automatically
multiplied by a factor of 3. |
:
:
Substantial equivalency - Differences (continued)
7
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/7/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized graphic of an abstract human figure with three horizontal lines extending from its back, all in black. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES (USA)" is arranged in a circular fashion around the graphic.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Roche Diagnostics Corp. c/o Mr. Kerwin L. Kaufman Regulatory Affairs Principal 9115 Hague Rd. Indianapolis, IN 46250
Re: K073277
Trade/Device Name: Roche C-Reactive Protein (Latex) Regulation Number: 21 CFR 866.5270 Regulation Name: C-reactive protein immunological test system Regulatory Class: Class II Product Code: DCN Dated: February 13, 2008 Received: February 19, 2008
Dear Mr. Kaufman:
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.
MAR - 6 2008
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
8
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" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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.
Robert Becker/
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
9
Indications for Use
510(k) Number (if known):
(013277
Device Name: Roche C-Reactive Protein (Latex)
Indications For Use:
In vitro test for the quantitative immunological determination of C-reactive protein in human serum and plasma on COBAS INTEGRA systems.
In vitro test for the quantitative determination of C-reactive protein in human serum and plasma on Roche/Hitachi cobas c systems.
Measurements of C-reactive protein aids in evaluation of the amount of injury to body tissues.
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)
Maria M. Han
Page 1 of ____________________________________________________________________________________________________________________________________________________________________
Division Slan-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K073277