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.

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.

AI/ML Overview

The provided text is a 510(k) summary for in-vitro diagnostic devices (EliA Immunoassays) and a separate 510(k) notification for a medical device (PANPAC HSG Catheter Set).

The request asks for information regarding acceptance criteria and a study proving a device meets these criteria. However, for the EliA Immunoassays, the document focuses on establishing substantial equivalence to predicate devices rather than defining specific acceptance criteria for performance and then proving the device meets them through a detailed study.

Therefore, the following information can be extracted for the EliA Immunoassays, but it's important to note the nature of the submission (510(k) for IVDs) means the "acceptance criteria" discussed are largely related to analytical performance demonstrating equivalence to predicates, not clinical efficacy or diagnostic accuracy against a definitive gold standard in the same way a new AI-powered diagnostic might be evaluated.

Here's an attempt to answer the questions based on the provided text for the EliA Immunoassays:

1. Table of acceptance criteria and the reported device performance

The document does not explicitly present a table of predetermined acceptance criteria with corresponding reported device performance values in the format usually seen for novel device approvals. Instead, it makes a general statement about laboratory equivalence based on comparison studies. The emphasis is on "substantial equivalence" to predicate devices.

The reported device performance, in this context, is that all available data support that the new devices are substantially equivalent to the predicate devices.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document states: "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)."

However, specific sample sizes for these comparison studies are not provided in this summary.
Data provenance (country of origin, retrospective/prospective) is also not specified.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This type of information is not applicable or provided for this 510(k) submission. For in-vitro diagnostic devices like these immunoassays, ground truth for "clinically defined sera" would typically come from a clinical diagnosis of antiphospholipid syndrome (APS) or related thrombotic disorders, which involves a constellation of clinical findings and laboratory tests, not solely expert interpretation of an image or single test. The document does not detail how the clinical status of the "clinically defined sera" was established or by whom.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This is not applicable or provided for this type of in-vitro diagnostic test. Adjudication methods are typically relevant for studies involving human interpretation of data, such as images, where multiple readers might offer differing opinions.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This is not applicable or provided. The device is an immunoassay for semi-quantitative measurement of antibodies, not an AI-powered diagnostic interpreted by human readers. Therefore, an MRMC study and
the concept of human readers improving with AI assistance are irrelevant in this context.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Yes, the device operates in a standalone manner as an "in vitro semi-quantitative measurement" system. The instruments (Phadia 100 and Phadia 250) are "fully automated immunoassay analyzers, which include software for evaluation of test results." The results are generated directly by the instrument.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" implicitly used for the studies mentioned ("clinically defined sera" and "samples from apparently healthy subjects") would be a combination of clinical diagnosis for patients with APS or thrombotic disorders, and the absence of disease for healthy subjects. The document does not specify the exact diagnostic criteria or the methods used to determine these clinical statuses.

8. The sample size for the training set

The document does not specify a training set sample size. For a traditional immunoassay device like this, the concept of a "training set" in the context of machine learning (AI) is not directly applicable. The device's performance is established through analytical validation and comparison with predicate devices, rather than an AI model training process.

9. How the ground truth for the training set was established

As there is no mention of an AI training set, this question is not applicable. For the development and validation of the immunoassays, the "ground truth" for calibrators would be established through a set of six WHO-standardized IgG and IgM Calibrators, derived from human serum, as mentioned in the "General Description of the New Devices." These calibrators define the assay's measurement scale.

Summary Limitations:

The provided 510(k) summary is for traditional in-vitro diagnostic immunoassays, not an AI-powered device. Therefore, many of the questions asked, particularly those related to expert adjudication, MRMC studies, and AI-specific training/test sets, are not applicable to the content of this document. The document focuses on demonstrating substantial equivalence to existing predicate devices based on analytical performance and comparability studies, rather than a de novo clinical validation against specific diagnostic accuracy criteria.

Summary

{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 ABRapsgatan 7SE-751 37 Uppsala, Sweden
510 (k) Contact Person:	Martin MannRegulatory Affairs ManagerPhadia US Inc.4169 Commercial AvenuePortage, Mi 49002, USA+1 (-269-492) -1957 (Phone)+1 (-269-492) -7541 (Fax)martin.mann@phadia.com
Device Name:	EliA™ Cardiolipin IgG ImmunoassayEliA™ Cardiolipin IgM ImmunoassayEliA™ β2-Glycoprotein I IgG ImmunoassayEliA™ β2-Glycoprotein I IgM ImmunoassayEliA™ 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 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

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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:

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:

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.

{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.

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

{18}------------------------------------------------

PANPAC HSG Catheter Set

Panpac Medical Corporation. 510(k) Notification

510(k) Number (if known):

K092983

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.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use	X
(Per 21 CFR 801. 109)

Over-The-Counter Use
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(Division Sign-Off)
Division of Reproductive, Abdominal and Radiological Devices
510(k) Number	K092983

Regulation Number and Section

§ 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).