(121 days)
Not Found
No
The device description and performance studies describe a standard immunoassay and calibration method, with no mention of AI or ML techniques.
No
The device is an immunoassay kit used for in vitro diagnostic testing to aid in the diagnosis of rheumatoid arthritis, not for treating a condition.
Yes
The "Intended Use / Indications for Use" states that the results of the assay are "intended to be used as an aid in the diagnosis of rheumatoid arthritis."
No
The device description clearly outlines physical components including reagents, calibrators, and controls, and specifies use on immunoassay analyzers, indicating it is a hardware-based in vitro diagnostic device, not software-only.
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 Elecsys Anti-CCP immunoassay is for the "in vitro semi-quantitative determination of human IgG autoantibodies to cyclic citrullinated peptides in human serum and plasma." The term "in vitro" is a key indicator of an IVD.
- Purpose: The assay is intended to be used "as an aid in the diagnosis of rheumatoid arthritis in combination with other clinical and laboratory findings." This clearly indicates a diagnostic purpose performed outside of the body.
- Device Description: The description details a laboratory test using reagents and analyzers to measure a substance in a biological sample (serum and plasma). This is characteristic of an IVD.
- Quality Control: The inclusion of Elecsys PreciControl Anti-CCP for "quality control of the Elecsys Anti-CCP immunoassay" further supports its use in a laboratory setting for diagnostic testing.
N/A
Intended Use / Indications for Use
(1) Elecsys Anti-CCP immunoassay: Immunoassay for the in vitro semi-quantitative determination of human IgG autoantibodies to cyclic citrullinated peptides in human serum and plasma. The results of the assay are intended to be used as an aid in the diagnosis of rheumatoid arthritis in combination with other clinical and laboratory findings. The electrochemiluminescence immunoassay "ECLIA" is intended for use on Elecsys and cobas e immunoassay analyzers.
(2) Elecsys PreciControl Anti-CCP is used for quality control of the Elecsys Anti-CCP immunoassay on the Elecsys and cobas e immunoassay analyzers.
Product codes (comma separated list FDA assigned to the subject device)
NHX, JJX
Device Description
(1) The Elecsys Anti-CCP immunoassay is a two step IgG-capture test principle immunoassay with streptavidin-coated microparticles and electrochemiluminescence detection. Results are determined using a calibration curve that is generated specifically on each instrument by a 2 point calibration and a master curve provided with the reagent bar code. The Elecsys Anti-CCP reagent kit consists of a Reagent Pack (R1, R2 and M[streptavidin-coated microparticles]) and lyophilized calibrators 1 and 2.
(2) The Elecsys PreciControl Anti-CCP is a lyophilized product consisting of human serum with added Anti-CCP antibody (human) in two concentration ranges. During manufacture, the antibody is spiked into the matrix at the desired concentration levels.
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)
Method Comparison: Elecsys Anti-CCP was compared to an anti-CCP microtiter plate ELISA assay (IMMUNOSCAN RA Anti-CCP test kit). 1606 samples were tested using a cut-off of >= 17 U/mL for the Elecsys Anti-CCP assay.
N=1606 Immunoscan Anti-CCP results:
Positive 428, Negative 18, Total 446.
Negative 26, Total 1134, 1160.
Total 454, 1152, 1606.
Positive Percent Agreement = 94.3% (95% CI = 91.7 - 96.2)
Negative Percent Agreement = 98.4% (95% CI = 97.5 - 99.1)
Total Percent Agreement = 97.3% (95% CI = 96.3 - 98.0)
Hook Effect: No high-dose hook effect at anti-CCP concentrations up to 7000 U/mL.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Positive Percent Agreement = 94.3% (95% CI = 91.7 - 96.2)
Negative Percent Agreement = 98.4% (95% CI = 97.5 - 99.1)
Total Percent Agreement = 97.3% (95% CI = 96.3 - 98.0)
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
Not Found
§ 866.5775 Rheumatoid factor immunological test system.
(a)
Identification. A rheumatoid factor immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the rheumatoid factor (antibodies to immunoglobulins) in serum, other body fluids, and tissues. Measurement of rheumatoid factor may aid in the diagnosis of rheumatoid arthritis.(b)
Classification. Class II (performance standards).
0
| 510(k) Summary | K081338 | SEP 11 2008 |
|---|---|---|
| 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 Road | ||
| Indianapolis, IN 46250 | ||
| Contact person: Stephanie Greeman | ||
| • Phone: (317) 521-2458 | ||
| • FAX: (317) 521-2324 | ||
| • email: stephanie.greeman@roche.com | ||
| Secondary contact : | ||
| Kay Taylor | ||
| • Phone: (317) 521-3544 | ||
| • FAX: (317) 521-2324 | ||
| • email: kay.taylor@roche.com | ||
| Date Prepared: May 9, 2008 | ||
| Device Name | Proprietary name: (1) Elecsys Anti-CCP Immunoassay | |
| (2) Elecsys PreciControl CCP | ||
| Common name: (1) Anti-CCP Assay | ||
| (2) PreciControl Anti-CCP | ||
| Classification name: (1) Antibodies, Anti-Cyclic Citrullinated Peptide | ||
| (2) Single (specified) analyte controls (Assayed and | ||
| Unassayed) | ||
| Device | ||
| Description | (1) The Elecsys Anti-CCP immunoassay is a two step IgG-capture test | |
| principle immunoassay with streptavidin-coated microparticles and | ||
| electrochemiluminescence detection. Results are determined using a | ||
| calibration curve that is generated specifically on each instrument by a 2 point | ||
| calibration and a master curve provided with the reagent bar code. | ||
| The Elecsys Anti-CCP reagent kit consists of a Reagent Pack (R1, R2 and M[streptavidin-coated microparticles]) and lyophilized calibrators 1 and 2. | ||
| (2) The Elecsys PreciControl Anti-CCP is a lyophilized product consisting of | ||
| human serum with added Anti-CCP antibody (human) in two concentration | ||
| ranges. During manufacture, the antibody is spiked into the matrix at the | ||
| desired concentration levels. | ||
| Note: The reagent is packaged with calibrators; controls are packaged | ||
| separately. | ||
| Intended use / | ||
| Indications for | ||
| Use | (1) Elecsys Anti-CCP immunoassay: Immunoassay for the in vitro semi- | |
| quantitative determination of human IgG autoantibodies to cyclic citrullinated | ||
| peptides in human serum and plasma. The results of the assay are intended to | ||
| be used as an aid in the diagnosis of rheumatoid arthritis in combination with | ||
| other clinical and laboratory findings. | ||
| The electrochemiluminescence immunoassay "ECLIA" is intended for use on | ||
| Elecsys and cobas e immunoassay analyzers. | ||
| (2) Elecsys PreciControl Anti-CCP is used for quality control of the Elecsys | ||
| Anti-CCP immunoassay on the Elecsys and cobas e immunoassay analyzers. | ||
| Substantial | ||
| equivalence | The Elecsys Anti-CCP Test System is substantially equivalent to other | |
| devices legally marketed in the United States. | ||
| (1) Elecsys Anti-CCP Immunoassay is equivalent to the Eurodiagnostica | ||
| IMMUNOSCAN RA Anti-CCP Test Kit (K052133). Both products are | ||
| intended for use in the semi-quantitative determination of human IgG | ||
| antibodies to cyclic citrullinated peptides in human serum. | ||
| (2) Elecsys PreciControl Anti-CCP is equivalent to the controls contained in | ||
| the Eurodiagnostica IMMUNOSCAN RA Anti-CCP Test Kit (K052133). | ||
| Continued on next page | ||
| Substantial | ||
| equivalence - | ||
| comparison | The following table compares the Elecsys Anti-CCP Immunoassay with the | |
| predicate device. | ||
| Immunoassay Comparison | ||
| Feature | Elecsys Anti-CCP Assay | Predicate Device |
| Eurodiagnostica IMMUNOSCAN | ||
| RA Anti-CCP Test Kit (K052133) | ||
| Intended Use / | ||
| Indication for | ||
| Use | Immunoassay for the in vitro semi- | |
| quantitative determination of human | ||
| IgG autoantibodies to cyclic | ||
| citrullinated peptides in human | ||
| serum and plasma. The results of | ||
| the assay are intended to be used as | ||
| an aid in the diagnosis of | ||
| rheumatoid arthritis in combination | ||
| with other clinical and laboratory | ||
| findings. | ||
| The electrochemiluminescence | ||
| immunoassay "ECLIA" is intended | ||
| for use on Elecsys and cobas e | ||
| immunoassay analyzers. | The Immunoscan RA anti-CCP test kit | |
| is an enzyme-linked immunosorbent | ||
| assay (ELISA) for detection and semi- | ||
| quantitation of IgG antibodies to | ||
| Cyclic Citrullinated Peptides (CCP) in | ||
| human sera. The assay is used to | ||
| detect antibodies in a single serum | ||
| specimen. The results of the assay are | ||
| to be used as an aid to the diagnosis of | ||
| Rheumatoid Arthritis (RA), in | ||
| conjunction with other laboratory and | ||
| clinical findings. The analysis should | ||
| be performed by trained laboratory | ||
| professionals. | ||
| Assay Protocol | IgG-capture test principle | ELISA - IgG adsorption |
| Detection | ||
| Protocol | electrochemiluminescence | |
| immunoassay (ECLIA) | photometric | |
| Traceability/ | ||
| Standardization | Standardized against a | |
| commercially available anti-CCP | ||
| assay | Not given | |
| Calibration | ||
| Interval | • After 1 month (28 days) when | |
| using the same reagent lot | ||
| • After 7 days (when using the | ||
| same reagent kit on the analyzer) | ||
| • As required: e.g. quality control | ||
| findings outside the specified | ||
| limits | Calibrate with each test | |
| Sample Type | Human serum and plasma | Human serum |
:
1
:
2
3
The following table compares the Elecsys Anti-CCP Immunoassay with the Substantial equivalence predicate device.
comparison
| Immunoassay Comparison, continued | ||
|---|---|---|
| Feature | Elecsys Anti-CCP Assay | Predicate Device |
| Eurodiagnostica IMMUNOSCAN | ||
| RA Anti-CCP Test Kit (K052133) | ||
| Reagent Stability | • Unopened up to the stated | |
| expiration date stored at 2 – 8°C | ||
| • On all analyzers: | ||
| • 1 week or | ||
| • maximum of 40 hours on the | ||
| analyzer; up to 4 weeks | ||
| when stored alternately in | ||
| the refrigerator and on the | ||
| analyzer. | Store kit at 2 – 8°C in a dark place up | |
| to stated expiration date. | ||
| Calibrator | Anti-CCP calibrators 1 and 2 | |
| supplied with kit | Five levels of calibrators supplied with | |
| kit | ||
| Controls | Elecsys PreciControl Anti-CCP 1 | |
| and 2 | Reference, positive, and negative | |
| controls supplied with kit | ||
| Expected Values | Positive: ≥ 17 U/mL | Negative: 5 mg/day), no sample should be taken until at least 8 hours after the last biotin administration. Interference was observed from Rheumatoid factor above concentrations of 150 IU/mL. |
| Bilirubin: ≤ 0.2 mg/mL Hemoglobin: ≤ 400 mg/dL Lipid: ≤ 15 mg/mL Rheumatoid factor: ≤ 200 IU/mL | ||
| Substantial | The following table compares the performance of Elecsys Anti-CCP | |
| equivalence - | Immunoassay with the predicate device. | |
| comparison | ||
| Immunoassay Performance Comparison, continued | ||
| Feature | Elecsys Anti-CCP Assay | Predicate Device |
| Eurodiagnostica IMMUNOSCAN | ||
| RA Anti-CCP Test Kit (K052133) | ||
| Limitations, | ||
| continued | Interference with pathologic levels of unspecific IgG can not be excluded. However, the coincidence of RA and gammopathy in one patient has been reported to be very low. The anti-CCP test results can be false negative in patients with hypergammaglobulinaemia. Results from patients suffering from this disorder should not be used for diagnostic purposes. In vitro tests were performed on 18 commonly used pharmaceuticals and in addition on methrotrexate and prednisolone. No interference with the assay was found. As with all tests containing monoclonal mouse antibodies, erroneous findings may be obtained from samples taken from patients who have been treated with monoclonal mouse antibodies or have received them for diagnostic purposes. |
6
l
ce -
The following table compares the performance of Elecsys Anti-CCP
Immunoassay with the predicate device.
7
| Substantial | The following table compares the performance of Elecsys Anti-CCP |
|---|---|
| equivalence - | Immunoassay with the predicate device. |
| comparison |
| Immunoassay Performance Comparison, continued | ||
|---|---|---|
| Feature | Elecsys Anti-CCP Assay | Predicate Device |
| Eurodiagnostica IMMUNOSCAN | ||
| RA Anti-CCP Test Kit (K052133) | ||
| Limitations, continued | The risk of interference from potential immunological interactions between test components and rare sera has been minimized by the inclusion of suitable additives. In rare cases, interference due to extremely high titers of antibodies to streptavidin and ruthenium can occur. The test contains additives which minimize these effects. For diagnostic purposes, the results should always be assessed in conjunction with the patient's medical history, clinical examination and other findings. |
:
Continued on next page
:
8
| Substantial
equivalence -
comparison | The following table compares the performance of Elecsys Anti-CCP
Immunoassay with the predicate device. |
| -------------------------------------------- | ------------------------------------------------------------------------------------------------------------ |
|---|
| Immunoassay Performance Comparison, continued | ||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Feature | Elecsys Anti-CCP Assay | Predicate Device | ||||||||||||||||||||||||||||||||||||||||||
| Eurodiagnostica IMMUNOSCAN | ||||||||||||||||||||||||||||||||||||||||||||
| RA Anti-CCP Test Kit (K052133) | ||||||||||||||||||||||||||||||||||||||||||||
| Method | ||||||||||||||||||||||||||||||||||||||||||||
| Comparison | Elecsys Anti-CCP was compared | |||||||||||||||||||||||||||||||||||||||||||
| anti-CCP microtiter plate ELISA | ||||||||||||||||||||||||||||||||||||||||||||
| assay (IMMUNOSCAN RA Anti- | ||||||||||||||||||||||||||||||||||||||||||||
| CCP test kit). |
1606 samples tested using a cut-off
of ≥ 17 U/mL for the Elecsys Anti-
CCP assay.
N=1606 Immunoscan
Anti-CCP + - Total Elecsys
Anti-
CCP + 428 18 446 - 26 1134 1160 total 454 1152 1606
Positive Percent Agreement = 94.3%
(95% CI = 91.7 – 96.2)
Negative Percent Agreement = 98.4%
(95% CI = 97.5 – 99.1)
Total Percent Agreement = 97.3%
(95% CI = 96.3 – 98.0) | | | | | | | | | | | | | | | | | | | | | | Percent agreement of the Immunoscan
RA CCP kit compared to an alternative
CCP ELISA:
A total of 320 frozen retrospective sera
were assayed. 175 samples were from
RA patients and 145 samples were
normals from a blood bank. The
following table summarizes the results.
Alternative ELISA Positive Negative Total Immuno
-scan
RA
CCP
Kit Positive 135 6 141 Negative 1 178 179 Total 136 184 320
Positive Percent Agreement = 99.3%
(95% CI = 93.2 – 100%)
Negative Percent Agreement = 96.7%
(95% CI = 81.6 – 99.9%)
Overall Percent Agreement = 97.8%
(95% CI = 93.2 – 100%)
The 95% confidence interval (CI) was
calculated using the exact method. | | | | | | | | | | | | | | | | | | | | | |
| Hook Effect | No high-dose hook effect at anti-
CCP concentrations up to 7000
U/mL | Not given. | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |
9
The following table compares the calibrators supplied with the Elecsys Anti-Substantial CCP immunoassay kit with the calibrators supplied with the predicate equivalence comparison device.
| Calibrator Comparison | ||
|---|---|---|
| Feature | Elecsys Anti-CCP Assay | Predicate Device |
| Eurodiagnostica IMMUNOSCAN | ||
| RA Anti-CCP Test Kit (K052133) | ||
| Levels | 2 | 5 |
| Format | Lyophilized | Liquid |
| Matrix | human serum | same |
| Analyte | ||
| Concentration | ||
| (Anti-CCP | ||
| antibodies; | ||
| human) | Calibrator 1: 20 U/mL | |
| Calibrator 2: 200 U/mL | Calibrator A: 1600 U/mL | |
| Calibrator B: 800 U/mL | ||
| Calibrator C: 200 U/mL | ||
| Calibrator D: 50 U/mL | ||
| Calibrator E: 25 U/mL | ||
| Stability | Unopened: | |
| • Until expiration date. | ||
| Reconstituted: | ||
| • On the analyzers at 20 – 25°C: | ||
| up to 2 hours | ||
| • At -20°C: up to 4 weeks (freeze | ||
| only once). | ||
| • After thawing: use only once. | N/A |
10
The following table compares the calibrators supplied with the Elecsys Anti-Substantial equivalence -CCP immunoassay kit with the calibrators supplied with the predicate comparison device.
| Calibrator Comparison, continued | ||
|---|---|---|
| Feature | Elecsys Anti-CCP Assay | Predicate Device |
| Eurodiagnostica IMMUNOSCAN | ||
| RA Anti-CCP Test Kit (K052133) | ||
| Handling | Dissolve carefully the contents of | |
| one bottle by adding exactly 1.0 mL | ||
| of distilled water and allow to stand | ||
| closed for 15 minutes to | ||
| reconstitute. Mix carefully, | ||
| avoiding the formation of foam. | ||
| Transfer the reconstituted calibrator | ||
| into the empty labeled snap-cap | ||
| bottles supplied (CalSet Vials). | ||
| Attach the supplied labels to the | ||
| additional bottles. Store the | ||
| aliquots immediately at -20°C. | ||
| Perform only one calibration | ||
| procedure per aliquot. All | ||
| information required for correct | ||
| operation is read in via the | ||
| respective reagent barcode. | N/A |
11
The following table compares the Elecsys PreciControl Anti-CCP with the Substantial controls supplied with the predicate device. equivalence comparison
| Control Comparison | ||
|---|---|---|
| Characteristic | Elecsys PreciControl Anti-CCP | Predicate Device |
| Eurodiagnostica IMMUNOSCAN | ||
| RA Anti-CCP Test Kit (K052133) | ||
| Intended Use | Used for quality control of the | |
| Elecsys Anti-CCP immunoassay on | ||
| the Elecsys and cobas e | ||
| immunoassay analyzers. | N/A | |
| Levels | Two | 3 |
| Format | Lyophilized | Liquid |
| Matrix | Human serum | same |
| Stability | Unopened: | |
| • Store at 2 – 8°C until expiration | ||
| date. | ||
| Reconstituted: | ||
| • On the analyzers at 20 – 25°C: up | ||
| to 5 hours | ||
| • At -20°C: up to 1 month (freeze | ||
| only once). | ||
| • After thawing: use only once. | N/A | |
| Analyte | ||
| Concentration | ||
| Control 1 | 20 U/mL Anti-CCP antibodies | |
| (human) | Negative Control | |
| (actual concentration not given) | ||
| Analyte | ||
| Concentration | ||
| Control 2 | 100 U/mL Anti-CCP antibodies | |
| (human) | Positive Control | |
| (actual concentration not given) | ||
| Analyte | ||
| Concentration | ||
| Control 3 | N/A | Reference Control |
| (actual concentration not given) |
12
The following table compares the Elccsys PreciControl Anti-CCP with the Substantial equivalence controls supplied with the predicate device. comparison
| Control Comparison, continued | ||
|---|---|---|
| Characteristic | Elecsys PreciControl Anti-CCP | Predicate Device |
| Eurodiagnostica IMMUNOSCAN | ||
| RA Anti-CCP Test Kit (K052133) | ||
| Handling | Dissolve carefully the contents of | |
| one bottle by adding exactly 2.0 mL | ||
| of distilled water and allow to stand | ||
| closed for 15 minutes to reconstitute. | ||
| Mix carefully, avoiding the | ||
| formation of foam. | ||
| Transfer aliquots of freshly | ||
| reconstituted controls into | ||
| appropriate tubes for storage. Store | ||
| the aliquots immediately at -20°C. | ||
| When measuring a non-barcoded | ||
| control, use only recommended | ||
| sample tubes, cup on tube or cup on | ||
| rack. Perform only one control | ||
| procedure per aliquot. | N/A |
13
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/13/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird with stylized wings and tail feathers.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
SEP 1 1 2008
Roche Diagnostics c/o Ms. Stephanie Greeman Regulatory Affairs Consultant US Regulatory Submissions 9115 Ilague Road Indianapolis, IN 46250
Re: K081338
Trade/Device Name: Elecsys Anti-CCP Immunoassay and Elecsys PreciControl Anti-CCP Regulation Number: 21 CFR 866.5775 Regulation Name: Rheumatoid factor immunological test system Regulatory Class: Class II Product Code: NHX, JJX Dated: July 31, 2008 Received: August 4, 2008
Dear Ms. Greeman:
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
14
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 advice for your device on our labeling regulation (21 CFR Part 801), 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,
Maria M Chan
Maria M. Chan, Ph.D. Acting Division Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
15
Elecsys Anti-CCP Test System
Confidential
Indication for Use – Elecsys Anti-CCP Immunoassay
510(k) Number (if known): K081338
Device Name: Elecsys Anti-CCP Immunoassay
Indication For Use:
Immunoassay for the in vitro semi-quantitative determination of human IgG autoantibodies to cyclic citrullinated peptides in human serum and plasma. The results of the assay are intended to be used as an aid in the diagnosis of rheumatoid arthritis in combination with other clinical and laboratory findings. The electrochemiluminescence immunoassay "ECLIA" is intended for use on Elecsys and cobas e immunoassay analyzers.
Prescription Use XXX (21 CFR Part 801 Subpart D) And/Or
Over the Counter Use (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OVD)
Maria M Chan
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K081338
16
Elecsys Anti-CCP Test System
Confidential
Indication for Use - Elecsys PreciControl Anti-CCP
K081338 510(k) Number (if known):
Device Name: Elecsys PreciControl Anti-CCP
Indication For Use:
Elecsys PreciControl Anti-CCP is used for quality control of the Elecsys Anti-CCP immunoassay on the Elecsys and cobas e immunoassay analyzers.
Prescription Use XXX (21 CFR Part 801 Subpart D)
And/Or
Over the Counter Use __ (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)
Nova M Chan
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K081338