(200 days)
No
The document describes a standard immunodiagnostic test system and does not mention any AI or ML components in the device description, intended use, or performance studies.
No
This device is an in vitro diagnostic (IVD) intended for the semi-quantitative measurement of antibodies as an aid in diagnosis, not for providing therapy or treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states that the devices are intended "as an aid in the clinical diagnosis" of various conditions, fitting the definition of a diagnostic device.
No
The device description explicitly states it is a "fully integrated and automated system for immunodiagnostic testing" that "comprises a Fluorescence-Immunoassay test system using EliA single wells as the solid phase" and includes "test-, method specific and general reagents that are packaged as separate units." This indicates the device includes significant hardware and reagent components, not just software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states "in vitro semi-quantitative measurement of IgG antibodies..." in human serum and plasma. This clearly indicates testing performed outside of the body on biological samples.
- Device Description: The description details a "Fluorescence-Immunoassay test system" using "EliA single wells as the solid phase" and performed on specific instruments. This describes a laboratory-based testing method.
- Regulatory Context: The submission includes predicate devices with K numbers, which are associated with FDA clearances for medical devices, including IVDs. The comparison study to predicate devices further supports its classification as a medical device intended for in vitro diagnostic use.
The information provided aligns perfectly with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
-
EliA™ CENP is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to CENP in human serum and plasma (heparin, EDTA, citrate) as an aid in the clinical diagnosis of scleroderma (CREST Syndrome) in conjunction with other laboratory and clinical findings. EliA™ CENP uses the EliA IgG method on the instruments ImmunoCAP® 100 and ImmunoCAP® 250.
-
EliA™ UIRNP is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to UIRNP in human serum and plasma (heparin, EDTA, citrate) as an aid in the clinical diagnosis of mixed connective tissue disease (MCTD) and systemic lupus erythematosus (SLE) in conjunction with other laboratory and clinical findings. EliA™ UIRNP uses the EliA IgG method on the instruments ImmunoCAP® 100 and ImmunoCAP® 250.
-
EliATM Sm is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to Sm in human serum and plasma (heparin, EDTA, citrate) as an aid in the clinical diagnosis of systemic lupus erythematosus (SLE) in conjunction with other laboratory and clinical findings. EliA™ Sm uses the EliA IgG method on the instruments ImmunoCAP® 100 and ImmunoCAP® 250.
-
EliA™ Ro is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to Ro in human serum and plasma (heparin, EDTA, citrate) as an aid in the clinical diagnosis of Sjögren's syndrome and systemic lupus erythematosus (SLE) in conjunction with other laboratory and clinical findings. EliA™ Ro uses the EliA IgG method on the instruments ImmunoCAP® 100 and ImmunoCAP® 250.
-
EliATM La is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to La in human serum and plasma (heparin, EDTA, citrate) as an aid in the clinical diagnosis of Siögren's syndrome and systemic lupus erythematosus (SLE) in conjunction with other laboratory and clinical findings. EliA™ La uses the EliA IgG method on the instruments ImmunoCAP® 100 and ImmunoCAP® 250.
Product codes
LJM
Device Description
The new devices belong to a fully integrated and automated system for immunodiagnostic testing. It comprises a Fluorescence-Immunoassay test system using EliA single wells as the solid phase and is intended to be performed on the instruments ImmunoCAP 100 and ImmunoCAP 250. The conjugate for the EliA IgG method is mouse anti-human IgG beta-galactosidase, which uses 4-Methylumbelliferyl-BD-Galactoside as substrate. The total IgG calibration is based on a set of six WHOstandardized IgG Calibrators derived from human serum. They are used to establish an initial calibration curve, which may be used for up to 28 days on additional assays and can be stored by the instrument. Each additional assay includes calibrator (curve) controls that have to recover in defined ranges to ensure that the stored calibration curve is still valid. The Fluorescence-Immunoassay test system includes test-, method specific and general reagents that are packaged as separate units.
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
The device is for prescription use only.
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
The comparability of predicate device and new device is supported by a data set including
- · results obtained within a comparison study between new and predicate devices
- results obtained for clinically defined sera
- results obtained for samples from apparently healthy subjects (normal population).
In summary, all available data support that the new devices are substantially equivalent to the predicate devices.
Key Metrics
Not Found
Predicate Device(s)
K944171, K993589, K000312, K922830, K944168
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 866.5100 Antinuclear antibody immunological test system.
(a)
Identification. An antinuclear antibody immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the autoimmune antibodies in serum, other body fluids, and tissues that react with cellular nuclear constituents (molecules present in the nucleus of a cell, such as ribonucleic acid, deoxyribonucleic acid, or nuclear proteins). The measurements aid in the diagnosis of systemic lupus erythematosus (a multisystem autoimmune disease in which antibodies attack the victim's own tissues), hepatitis (a liver disease), rheumatoid arthritis, Sjögren's syndrome (arthritis with inflammation of the eye, eyelid, and salivary glands), and systemic sclerosis (chronic hardening and shrinking of many body tissues).(b)
Classification. Class II (performance standards).
0
KOD225-9
510(k) Summary of Safety and Effectiveness
APR 1 0 2009
This summary of safety and effectiveness information is being submitted in accordance with the requirements of The Safety Medical Devices Act of 1990 (SMDA 1990) and 21 CFR Part 807.92.
| Assigned 510(k) Number: | |
|---|---|
| Date of Summary Preparation: | September 18, 2008 |
| Manufacturer: | Phadia AB |
| Rapsgatan 7 | |
| SE-751 37 Uppsala, Sweden | |
| 510 (k) Contact Person: | Martin Mann |
| Regulatory Affairs Manager | |
| Phadia US Inc. | |
| 4169 Commercial Avenue | |
| Portage, Mi 49002, USA | |
| +1 (-269-492) -1957 (Phone) | |
| +1 (-269-492) -7541 (Fax) | |
| martin.mann@phadia.com | |
| Device Name: | EliA™ CENP Immunoassay |
| EliA™ U1RNP Immunoassay | |
| EliA™ Sm Immunoassay | |
| EliA™ Ro Immunoassay | |
| EliA™ La Immunoassay | |
| Common Name: | Antinuclear antibody immunological test system and |
| Control | |
| Classification |
| Product Name | Product Code | Class | CFR |
|---|---|---|---|
| EliATM CENP | LJM | II | 866.5100 |
| EliATM U1RNP | LJM | II | 866.5100 |
| EliATM Sm | LJM | II | 866.5100 |
| EliATM Ro | LJM | II | 866.5100 |
| EliATM La | LJM | II | 866.5100 |
1
Substantial Equivalence to
| Varelisa CENP Antibodies | K944171 |
|---|---|
| Varelisa U1RNP Antibodies | K993589 |
| Varelisa Sm Antibodies | K000312 |
| Quanta Lite SS-A ELISA | K922830 |
| Varelisa SS-B/La Antibodies | K944168 |
Intended Use Statements of the New Devices
-
EliA™ CENP is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to CENP in human serum and plasma (heparin, EDTA, citrate) as an aid in the clinical diagnosis of scleroderma (CREST Syndrome) in conjunction with other laboratory and clinical findings. EliA™ CENP uses the EliA IgG method on the instruments ImmunoCAP® 100 and ImmunoCAP® 250.
-
EliA™ UIRNP is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to UIRNP in human serum and plasma (heparin, EDTA, citrate) as an aid in the clinical diagnosis of mixed connective tissue disease (MCTD) and systemic lupus erythematosus (SLE) in conjunction with other laboratory and clinical findings. EliA™ UIRNP uses the EliA IgG method on the instruments ImmunoCAP® 100 and ImmunoCAP® 250.
-
EliATM Sm is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to Sm in human serum and plasma (heparin, EDTA, citrate) as an aid in the clinical diagnosis of systemic lupus erythematosus (SLE) in conjunction with other laboratory and clinical findings. EliA™ Sm uses the EliA IgG method on the instruments ImmunoCAP® 100 and ImmunoCAP® 250.
-
EliA™ Ro is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to Ro in human serum and plasma (heparin, EDTA, citrate) as an aid in the clinical diagnosis of Sjögren's syndrome and systemic lupus erythematosus (SLE) in conjunction with other laboratory and clinical findings. EliA™ Ro uses the EliA IgG method on the instruments ImmunoCAP® 100 and ImmunoCAP® 250.
-
EliATM La is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to La in human serum and plasma (heparin, EDTA, citrate) as an aid in the clinical diagnosis of Siögren's syndrome and systemic lupus erythematosus (SLE) in conjunction with other laboratory and clinical findings. EliA™ La uses the EliA IgG method on the instruments ImmunoCAP® 100 and ImmunoCAP® 250.
2
Special condition for use statement
The device is for prescription use only.
Special instrument requirements
ImmunoCAP® 100/ImmunoCAP® 250 are fully automated immunoassay analyzers, which include software for evaluation of test results.
General Description of the New Devices
The new devices belong to a fully integrated and automated system for immunodiagnostic testing. It comprises a Fluorescence-Immunoassay test system using EliA single wells as the solid phase and is intended to be performed on the instruments ImmunoCAP 100 and ImmunoCAP 250. The conjugate for the EliA IgG method is mouse anti-human IgG beta-galactosidase, which uses 4-Methylumbelliferyl-BD-Galactoside as substrate. The total IgG calibration is based on a set of six WHOstandardized IgG Calibrators derived from human serum. They are used to establish an initial calibration curve, which may be used for up to 28 days on additional assays and can be stored by the instrument. Each additional assay includes calibrator (curve) controls that have to recover in defined ranges to ensure that the stored calibration curve is still valid. The Fluorescence-Immunoassay test system includes test-, method specific and general reagents that are packaged as separate units.
Test Principle of the New Devices
The EliA Wells are coated with the following antigens:
| Test | Antigen coated to the wells: |
|---|---|
| Elia CENP | human recombinant centromere protein B |
| Elia U1RNP | human recombinant RNP (RNP 70 kDa, A, C) protein |
| Elia Sm | native Sm proteins purified from bovine tissue |
| Elia Ro | human recombinant SS-A/Ro (60 kDa, 52 kDa) protein |
| Elia La | human recombinant SS-B/La protein |
If present in the patient's specimen, antibodies to the antigens mentioned above bind to their specific antigen. After washing away non-bound antibodies, enzyme-labeled antibodies against human IgG antibodies (EliA IgG Conjugate) are added to form an antibody-conjugate complex. After incubation, non-bound conjugate is washed away and the bound complex is incubated with a Development Solution. After stopping the reaction, the fluorescence in the reaction mixture is measured. The higher the response value, the more specific IgG is present in the specimen. To evaluate test results, the response for patient samples is compared directly to the response for calibrators.
3
Device Comparison
The new and the predicate devices both represent non-competitive solid phase ELISAs. Both IVDs are used as an aid in the diagnosis of the following diseases:
| Disease | Detection of antibodies to |
|---|---|
| scleroderma (CREST Syndrome) | CENP |
| mixed connective tissue disease (MCTD) | U1RNP |
| systemic lupus erythematosus (SLE) | Sm, U1RNP, Ro, La |
| Sjögren's syndrome | Ro, La |
Laboratory equivalence
The comparability of predicate device and new device is supported by a data set including
- · results obtained within a comparison study between new and predicate devices
- results obtained for clinically defined sera
- results obtained for samples from apparently healthy subjects (normal population).
In summary, all available data support that the new devices are substantially equivalent to the predicate devices.
4
Image /page/4/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
APR 1 0 2009
Phadia US, Inc c/o Mr. Martin R. Mann Regulatory Affairs Manager 4169 Commercial Ave Portage, Michigan 49002
Re: K082759
Trade/Device Name: EliA™ CENP EliA™ U1RNP EliA™ Sm EliA™ Ro EliA™ La
Regulation Number: 21 CFR 866.5100 Regulation Name: Antinuclear antibody immunological test system Regulatory Class: II Product Code: LJM Dated: April 3, 2009 Received: April 6, 2009
Dear Mr. Mann:
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 ffor 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);
5
Page 2 -- Mr. Martin Mann
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). 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 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" (21CFR 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,
mchan
Maria M. Chan. 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
6
510(k) Number (if known): K082759
EliA Sm Well Device Name:
Indication For Use:
EliA™ Sm is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to Sm in human serum and plasma (heparin, EDTA, citrate) as an aid in the clinical diagnosis of systemic lupus erythematosus (SLE) in conjunction with other laboratory and clinical findings. EliA™ Sm uses the EliA IgG method on the instruments ImmunoCAP® 100 and ImmunoCAP® 250.
Prescription Use V (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)
ia mchan
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K082757
Page 1 of 1
7
510(k) Number (if known): K082759
EliA La Well Device Name:
Indication For Use:
EliA™ La is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to La in human serum and plasma (heparin, EDTA, citrate) as an aid in the clinical diagnosis of Sjögren's syndrome and systemic lupus erythematosus (SLE) in conjunction with other laboratory and clinical findings. EliA™ La uses the EliA IgG method on the instruments ImmunoCAP® 100 and ImmunoCAP® 250.
Prescription Use V (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) K082719
Page I of 1
8
510(k) Number (if known): K082759
EliA Ro Well Device Name:
Indication For Use:
EliA™ Ro is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to Ro in human serum and plasma (heparin, EDTA, citrate) as an aid in the clinical diagnosis of Sjögren's syndrome and systemic lupus erythematosus (SLE) in conjunction with other laboratory and clinical findings. EliA™ Ro uses the EliA IgG method on the instruments ImmunoCAP® 100 and ImmunoCAP® 250.
Prescription Use V (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) K082759
Page 1 of 1
9
510(k) Number (if known): K082759
EliA U1RNP Well Device Name:
Indication For Use:
EliA™ U1RNP is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to U1RNP in human serum and plasma (heparin, EDTA, citrate) as an aid in the clinical diagnosis of mixed connective tissue disease (MCTD) and systemic lupus erythematosus (SLE) in conjunction with other laboratory and clinical findings. EliA™ U1RNP uses the EliA IgG method on the instruments ImmunoCAP® 100 and ImmunoCAP® 250.
Prescription Use __ V_ (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)
Marie M. Chan
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) Kof2 7√-9
10
510(k) Number (if known): K082759
Device Name: EliA CENP Well
Indication For Use:
EliA™ CENP is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to CENP in human serum and plasma (heparin, EDTA, citrate) as an aid in the clinical diagnosis of scleroderma (CREST Syndrome) in conjunction with other laboratory and clinical findings. EliA™ CENP uses the EliA IgG method on the instruments ImmunoCAP® 100 and ImmunoCAP® 250.
Prescription Use __ V_ (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)
m. Chan
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K082759
Page 1 of 1