(350 days)
Not Found
No
The document describes a standard automated immunodiagnostic system and does not mention any AI or ML components in the device description or performance studies.
No.
The device is described as an "in vitro semi-quantitative measurement" system "to aid in the diagnosis" and for "monitoring the performance," indicating it's a diagnostic tool, not one that treats or cures a disease.
Yes
The intended use statements specifically state that the devices "aid in the diagnosis" of various conditions, which is the primary characteristic of a diagnostic device.
No
The device description clearly 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 is performed on specific instruments (Phadia 100 and Phadia 250). This indicates the device includes hardware components and reagents, not just software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use statements explicitly state that the devices are for "in vitro semi-quantitative measurement" of antibodies in human serum and plasma. This clearly indicates that the testing is performed outside of the living body using biological samples.
- Device Description: The device description details a "Fluorescence-Immunoassay test system" that uses "EliA single wells as the solid phase" and is performed on specific instruments (Phadia 100 and Phadia 250). This describes a laboratory-based testing method.
- Intended User / Care Setting: The intended user is "Laboratory use; Prescription use only." This further confirms that the device is designed for use in a clinical laboratory setting for diagnostic purposes.
All of these points align with the definition of an In Vitro Diagnostic device, which is a medical device intended for use in vitro for the examination of specimens derived from the human body solely or principally for the purpose of providing information concerning a physiological or pathological state, or concerning a congenital abnormality, or to monitor therapeutic measures.
N/A
Intended Use / Indications for Use
-
EliA Cardiolipin IgG is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to cardiolipin in human serum and plasma (Li-heparin, EDTA, citrate) to aid in the diagnosis of antiphospholipid syndrome (APS) as well as thrombotic disorders related to secondary antiphospholipid syndrome in conjunction with other laboratory and clinical findings. EliA Cardiolipin IgG uses the the EliA IgG method on the instruments Phadia 100 and Phadia 250.
-
EliA Cardiolipin IgM is intended for the in vitro semi-quantitative measurement of IgM antibodies directed to cardiolipin in human serum and plasma (Li-heparin, EDTA, citrate) to aid in the diagnosis of antiphospholipid syndrome (APS) as well as thrombotic disorders related to secondary antiphospholipid syndrome in conjunction with other laboratory and clinical findings. EliA Cardiolipin IgM uses the the EliA IgM method on the instruments Phadia 100 and Phadia 250.
-
EliA B2-Glycoprotein I IgG is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to B2-Glycoprotein I in human serum and plasma (Li-heparin, EDTA, citrate) to aid in the diagnosis of antiphospholipid syndrome (APS) a as well as thrombotic disorders related to secondary antiphospholipid syndrome in conjunction with other laboratory and clinical findings. EliA B2-Glycoprotein I IgG uses the the EliA IgG method on the instruments Phadia 100 and Phadia 250.
-
EliA B2-Glycoprotein I IgM is intended for the in vitto semi-quantitative measurement of IgM antibodies directed to ß2-Glycoprotein I in human serum and plasma (Li-heparin, EDTA, citrate) to aid in the diagnosis of antiphospholipid syndrome (APS) as well as thrombotic disorders related to secondary antiphospholipid syndrome in conjunction with other laboratory and clinical findings. EliA B2-Glycoprotein I IgM uses the the EliA IgM method on the instruments Phadia 100 and Phadia 250.
-
EliA APS Positive Control 100 is intended for laboratory use in monitoring the performance of in vitro measurement of antibodies to cardiolipin and B2-Glycoprotein I with Phadia 100 using the EliA IgG or IgM method.
-
EliA APS Positive Control 250 is intended for laboratory use in monitoring the performance of in vitro measurement of antibodies to cardiolipin and ß2-Glycoprotein I with Phadia 250 using the EliA IgG or IgM method.
Product codes (comma separated list FDA assigned to the subject device)
MID, MSV, JJY
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 Phadia 100 and Phadia 250.
The conjugate for the EliA IgG method is mouse anti-human IgG beta-galactosidase, which uses 4-Methylumbellifery I-BD-Galactoside as substrate.
The conjugate for the EliA IgM method is mouse anti-human IgM beta-galactosidase, which uses 4-Methylumbelliferyl-ßD-Galactoside as substrate.
The total IgG and IgM calibration is based on a set of six WHO-standardized IgG and IgM Calibrators, respectively, 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.
The EliA Wells are coated with the following antigens:
EliA Cardiolipin IgG/IgM: Bovine cardiolipin antigen and bovine ß2-glycoprotein as co-factor
EliA ß2-Glycoprotein I IgG/IgM: Human ß2-Glycoprotein I antigen
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 or IgM antibodies (EliA IgG or IgM 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 or IgM is present in the specimen. To evaluate test results, the response for patient samples is compared directly to the response for calibrators.
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
Laboratory use. 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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 device
- 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 (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
K020752, K020758, K040449, K040451
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
§ 866.5660 Multiple autoantibodies immunological test system.
(a)
Identification. A multiple autoantibodies immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the autoantibodies (antibodies produced against the body's own tissues) in serum and other body fluids. Measurement of multiple autoantibodies aids in the diagnosis of autoimmune disorders (disease produced when the body's own tissues are injured by autoantibodies).(b)
Classification. Class II (performance standards).
0
510(k) Summary of Safety and Effectiveness
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: | K091845 |
|---|---|
| Date of Summary Preparation: | May 27, 2009 |
| 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™ Cardiolipin IgG Immunoassay |
| EliA™ Cardiolipin IgM Immunoassay | |
| EliA™ β2-Glycoprotein I IgG Immunoassay | |
| EliA™ β2-Glycoprotein I IgM Immunoassay | |
| EliA™ APS Positive Control | |
| Common Name: | Cardiolipin autoantibody immunological test |
Common Name:
st system Cardloriphi autoantibody immunological test system
Classification
| Product Name | Product Code | Class | CFR |
|---|---|---|---|
| EliATM Cardiolipin IgG | MID | II | 866.5660 |
| EliATM Cardiolipin IgM | MID | II | 866.5660 |
| EliATM β2-Glycoprotein I IgG | MSV | II | 866.5660 |
| EliATM β2-Glycoprotein I IgM | MSV | II | 866.5660 |
| EliATM APS Positive Control | JJY | I | 862.1660 |
1
Substantial Equivalence to
| Varelisa Cardiolipin IgG Antibodies | K020752 |
|---|---|
| Varelisa Cardiolipin IgM Antibodies | K020758 |
| Varelisa β2-Glycoprotein I IgG Antibodies | K040449 |
| Varelisa β2-Glycoprotein I IgM Antibodies | K040451 |
Intended Use Statements of the New Devices
-
EliA Cardiolipin IgG is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to cardiolipin in human serum and plasma (Li-heparin, EDTA, citrate) to aid in the diagnosis of antiphospholipid syndrome (APS) as well as thrombotic disorders related to secondary antiphospholipid syndrome in conjunction with other laboratory and clinical findings. EliA Cardiolipin IgG uses the the EliA IgG method on the instruments Phadia 100 and Phadia 250.
-
EliA Cardiolipin IgM is intended for the in vitro semi-quantitative measurement of IgM antibodies directed to cardiolipin in human serum and plasma (Li-heparin, EDTA, citrate) to aid in the diagnosis of antiphospholipid syndrome (APS) as well as thrombotic disorders related to secondary antiphospholipid syndrome in conjunction with other laboratory and clinical findings. EliA Cardiolipin IgM uses the the EliA IgM method on the instruments Phadia 100 and Phadia 250.
-
EliA B2-Glycoprotein I IgG is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to B2-Glycoprotein I in human serum and plasma (Li-heparin, EDTA, citrate) to aid in the diagnosis of antiphospholipid syndrome (APS) a as well as thrombotic disorders related to secondary antiphospholipid syndrome in conjunction with other laboratory and clinical findings. EliA B2-Glycoprotein I IgG uses the the EliA IgG method on the instruments Phadia 100 and Phadia 250.
-
EliA B2-Glycoprotein I IgM is intended for the in vitto semi-quantitative measurement of IgM antibodies directed to ß2-Glycoprotein I in human serum and plasma (Li-heparin, EDTA, citrate) to aid in the diagnosis of antiphospholipid syndrome (APS) as well as thrombotic disorders related to secondary antiphospholipid syndrome in conjunction with other laboratory and clinical findings. EliA B2-Glycoprotein I IgM uses the the EliA IgM method on the instruments Phadia 100 and Phadia 250.
-
EliA APS Positive Control 100 is intended for laboratory use in monitoring the performance of in vitro measurement of antibodies to cardiolipin and B2-Glycoprotein I with Phadia 100 using the EliA IgG or IgM method.
-
EliA APS Positive Control 250 is intended for laboratory use in monitoring the performance of in vitro measurement of antibodies to cardiolipin and ß2-Glycoprotein I with Phadia 250 using the EliA IgG or IgM method.
2
Special condition for use statement
The device is for prescription use only.
Special instrument requirements
Phadia® 100/Phadia® 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 Phadia 100 and Phadia 250.
The conjugate for the EliA IgG method is mouse anti-human IgG beta-galactosidase, which uses 4-Methylumbellifery I-BD-Galactoside as substrate.
The conjugate for the EliA IgM method is mouse anti-human IgM beta-galactosidase, which uses 4-Methylumbelliferyl-ßD-Galactoside as substrate.
The total IgG and IgM calibration is based on a set of six WHO-standardized IgG and IgM Calibrators, respectively, 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 Cardiolipin IgG/IgM | Bovine cardiolipin antigen and bovine ß2- |
| glycoprotein as co-factor | |
| EliA ß2-Glycoprotein I IgG/IgM | Human ß2-Glycoprotein I antigen |
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 or IgM antibodies (EliA IgG or IgM 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 or IgM 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 certain autoimmune disease thrombotic disorders, such as those secondary to systemic lupus erythematosus (SLE) or other lupus-like thrombotic diseases.
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 device
- 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
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle symbol on the right and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the left side of the image. The eagle symbol is composed of flowing lines, and the text is in a sans-serif font.
Public Health Service
Food & Drug Administration 10903 New Hampshire Avenue Building 66 Silver Spring, MD 20993
JUN 0 7 2010
Phadia US Inc. c/o Mr. Martin Mann Regulatory Affairs Manager 4169 Commercial Avenue Portage, MI 49002
Re: K091845
Trade/Device Name:
Regulation Number:
Regulation Name:
Regulatory Class:
Product Code:
EliATM Cardiolipin IgG on the Phadia 100 and 250 instruments EliA™ Cardiolipin IgM on the Phadia 100 and 250 instruments EliATM B2-Glycoprotein I IgG on the Phadia 100 and 250 instruments EliATM ß2-Glycoprotein I IgM on the Phadia 100 and 250 instruments EliATM APS Positive Control 100 EliATM APS Positive Control 250 21 CFR 8866.5660 Multiple Autoantibodies Immunological Test System Class II MID, MSV, JJY June 3, 2010 June 4. 2010
Dear Mr. Mann:
Dated:
Received:
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 class II (Special Controls), 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.
5
Page 2 - Mr. Martin Mann
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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).796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
ia m chen
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): K091845
Device Name:
EliATM Cardiolipin IgG
Indication For Use:
EliA Cardiolipin IgG is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to cardiolipin in human serum and plasma (Li-heparin, EDTA, citrate) to aid in the diagnosis of antiphospholipid syndrome (APS) as well as thrombotic disorders related to secondary antiphospholipid syndrome in conjunction with other laboratory and clinical findings. EliA Cardiolipin IgG uses the EliA IgG method on the instrument Phadia 100.
Prescription Use (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)
Reena. Philip.
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) k09/845
7
510(k) Number (if known): K091845
Device Name:
EliATM Cardiolipin IgG
Indication For Use:
EliA Cardiolipin IgG is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to cardiolipin in human serum and plasma (Li-heparin, EDTA, citrate) to aid in the diagnosis of antiphospholipid syndrome (APS) as well as thrombotic disorders related to secondary antiphospholipid syndrome in conjunction with other laboratory and clinical findings. EliA Cardiolipin IgG uses the EliA IgG method on the instrument Phadia 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)
Reena Philip
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K091845
8
510(k) Number (if known): K091845
Device Name:
EliA™ Cardiolipin IgM
Indication For Use:
EliA Cardiolipin IgM is intended for the in vitro semi-quantitative measurement of IgM antibodies directed to cardiolipin in human serum and plasma (Li-heparin, EDTA, citrate) to aid in the diagnosis of antiphospholipid syndrome (APS) as well as thrombotic disorders related to secondary antiphospholipid syndrome in conjunction with other laboratory and clinical findings. EliA Cardiolipin IgM uses the EliA IgM method on the instrument Phadia 100.
Prescription Use (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)
Reena Philip
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K091845
9
510(k) Number (if known): K091845
Device Name:
EliA™ Cardiolipin IgM
Indication For Use:
EliA Cardiolipin IgM is intended for the in vitro semi-quantitative measurement of IgM antibodies directed to cardiolipin in human serum and plasma (Li-heparin, EDTA, citrate) to aid in the diagnosis of antiphospholipid syndrome (APS) as well as thrombotic disorders related to secondary antiphospholipid syndrome in conjunction with other laboratory and clinical findings. EliA Cardiolipin IgM uses the EliA IgM method on the instrument Phadia 250.
Prescription Use (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)
Reena Philip
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K091845
10
510(k) Number (if known): K091845
Device Name:
EliATM B2-Glycoprotein I IgG
Indication For Use:
EliA ß2-Glycoprotein I IgG is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to ß2-Glycoprotein I in human serum and plasma (Li-heparin, EDTA, citrate) to aid in the diagnosis of antiphospholipid syndrome (APS) as well as thrombotic disorders related to secondary antiphospholipid syndrome in conjunction with other laboratory and clinical findings. EliA B2-Glycoprotein I IgG uses the EliA IgG method on the instrument Phadia 100.
V Prescription Use (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)
Reena Philip
510(k) k 091845
11
510(k) Number (if known): K091845
Device Name:
EliATM ß2-Glycoprotein I IgG
Indication For Use:
EliA ß2-Glycoprotein I IgG is intended for the in vitro semi-quantitative measurement of IgG antibodies directed to ß2-Glycoprotein I in human serum and plasma (Li-heparin, EDTA, citrate) to aid in the diagnosis of antiphospholipid syndrome (APS) as well as thrombotic disorders related to secondary antiphospholipid syndrome in conjunction with other laboratory and clinical findings. EliA ß2-Glycoprotein I IgG uses the EliA IgG method on the instrument Phadia 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)
Reena Philip
510(k) K091845
12
K091845 510(k) Number (if known):
Device Name:
EliATM B2-Glycoprotein I IgM
Indication For Use:
EliA ß2-Glycoprotein I IgM is intended for the in vitro semi-quantitative measurement of IgM antibodies directed to ß2-Glycoprotein I in human serum and plasma (Li-heparin, EDTA, citrate) to aid in the diagnosis of antiphospholipid syndrome (APS) as well as thrombotic disorders related to secondary antiphospholipid syndrome in conjunction with other laboratory and clinical findings. EliA B2-Glycoprotein I IgM uses the EliA IgM method on the instrument Phadia 100.
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)
Reeve Philip
510(k) K091845
13
K091845 510(k) Number (if known):
Device Name:
EliATM B2-Glycoprotein I IgM
Indication For Use:
EliA ß2-Glycoprotein I IgM is intended for the in vitro semi-quantitative measurement of IgM antibodies directed to ß2-Glycoprotein I in human serum and plasma (Li-heparin, EDTA, citrate) to aid in the diagnosis of antiphospholipid syndrome (APS) as well as thrombotic disorders related to secondary antiphospholipid syndrome in conjunction with other laboratory and clinical findings. EliA ß2-Glycoprotein I IgM uses the EliA IgM method on the instrument Phadia 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)
Reena Philip
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K091845
14
510(k) Number (if known): کی کارک
Device Name:
EliA™ APS Positive Control 100
Indication For Use:
EliA APS Positive Control 100 is intended for laboratory use in monitoring the performance of in vitro measurement of antibodies to cardiolipin and ß2-Glycoprotein I with Phadia 100 using the EliA IgG or IgM method.
Prescription Use (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)
Reena Philip
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K091845
15
510(k) Number (if known):
Device Name:
EliATM APS Positive Control 250
Indication For Use:
EliA APS Positive Control 250 is intended for laboratory use in monitoring the performance of in vitro measurement of antibodies to cardiolipin and ß2-Glycoprotein I with Phadia 250 using the EliA IgG or IgM method.
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)
Reena Philip
510(k) K091845
16
Image /page/16/Picture/0 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the department's name around the perimeter. In the center of the seal is an abstract image of an eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-Gt Silver Spring, MD 20993-0002
Yen-Ming Pan President PANPAC Medical Corp. 6F-2, No. 202, SEC. 3, Ta-Tong Road Shi-Chih City, Taipei Hsien, 22103 TAIWAN R.O.C.
K092983 Re.
Trade/Device Name: PANPAC HSG Catheter Set Regulation Number: None Regulatory Class: Unclassified Product Code: LKF Dated: May 3, 2010 Received: May 6, 2010
Dear Mr. Pan:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
JUN - 7 2010
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting of medical device-related
17
adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21-CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Janine M. Morris
Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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PANPAC HSG Catheter Set
Panpac Medical Corporation. 510(k) Notification
510(k) Number (if known):
Device Name: PANPAC HSG Catheter Set
Indications for Use:
PANPAC HSG catheter sets are indicated to evaluate the causes of abnormal uterine bleeding, menstrual disorders, recurring pregnancy loss, or unexplained infertility. They can also be used to assess uterine pathology and patients on tamoxifan therapy.
HSG type catheter sets are used to infuse a fluid (either a contrast media or a sterile saline) into the uterine cavity while blocking the external cervical os to retain the fluid in the uterus during the procedure.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | X |
|---|---|
| (Per 21 CFR 801. 109) |
OR
| Over-The-Counter Use | |
|---|---|
| ---------------------- | -- |
| (Division Sign-Off) | |
|---|---|
| Division of Reproductive, Abdominal and Radiological Devices | |
| 510(k) Number | K092983 |