The HYDRAGEL 18 A1AT ISOFOCUSING kit is designed for the qualitative detection and identification of the different phenotypes of Alpha-1 antitrypsin (A1AT). Phenotyping results in conjunction with clinical findings and other laboratory assays aid in the diagnosis of Alpha-1 antitrypsin deficiency The analysis is performed on human sera separated into electrophoretic patterns ready for qualitative analysis. The procedure includes isoelectrofocusing on agarose gel, performed on the semi-automatic HYDRASYS system, followed by immunofixation with anti-Alpha-1 antitrypsin antiserum. The use of enzyme labeled anti-Alpha-1 antiserum enhanced the detection and identification of the different phenotypes.

Device Description

The configurations of the HYDRAGEL 18 A1AT ISOFOCUSING kit consist of the components summarized in Tables I and II in main 510(k) submission. Each kit is supplied with Package Insert which contains instruction for use and all the necessary information on the reagents needed to run the tests that are sold separately. Each Package Insert also contains information on storage conditions, shelf-life and signs of deterioration of the kit components and the reagents sold separately, and on interpretation of the results.

AI/ML Overview

The provided 510(k) summary for the SEBIA HYDRAGEL 18 A1AT ISOFOCUSING kit describes a traditional IVD device, not an AI/ML device. Therefore, the concepts of acceptance criteria for AI algorithms, sample sizes for test/training sets, expert ground truth establishment, MRMC studies, or standalone algorithm performance are not applicable in their usual sense.

The submission focuses on demonstrating substantial equivalence to a predicate device for the qualitative detection and identification of Alpha-1 antitrypsin (A1AT) phenotypes. The "acceptance criteria" here relate to the device showing comparable performance to the predicate method.

Here's an interpretation based on the given information, adapted for an IVD device submission:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly state quantitative acceptance criteria in the typical sense of sensitivity/specificity/accuracy thresholds that an AI/ML algorithm might have. Instead, the acceptance criterion implicitly is "substantial equivalence" to the predicate device. The performance is demonstrated through concordance and reproducibility studies.

Acceptance Criteria (Implicit for Substantial Equivalence)	Reported Device Performance (Summary)
Concordance with predicate device	Performance matches predicate: "Data are presented documenting substantial equivalency of the SEBIA and the polyacrylamide gel isoelectric focusing technique for Alpha-1 antitrypsin phenotype characterization."
Within-gel reproducibility	Satisfactory results reported
Gel-to-gel and lot-to-lot reproducibility	Satisfactory results reported
Sensitivity of detection of phenotypes	Satisfactory results reported
Validation	Satisfactory results reported
Stability	Satisfactory results reported

2. Sample Size Used for the Test Set and Data Provenance

The exact sample size for the concordance study (which would act as the "test set" for equivalence) is not explicitly stated in the provided text. The document mentions "Performance study and comparisons of the HYDRAGEL 18 A1AT ISOFOCUSING KITS with polyacrylamide gels isoelectric focusing and comassie blue staining was done." and "Data are presented documenting substantial equivalency...".

Sample Size for Test Set: Not explicitly provided.
Data Provenance: Not explicitly stated, though the comparative predicate technique is described as "currently used in clinical diagnostic laboratories in the United States." This suggests the comparison data would likely derive from similar clinical settings. The nature of the study (comparison to an existing method) suggests it would be retrospective as it's comparing against previously characterized samples or existing results.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

Since this is a laboratory assay where the "ground truth" is established by a predicate analytical method (polyacrylamide gel isoelectric focusing with Coomassie Blue staining), the concept of "experts" establishing ground truth in the traditional sense of clinical opinion is not directly applicable. The "ground truth" here is the result obtained from the well-established predicate method. The reading and interpretation of the gels would likely be performed by trained laboratory personnel, but no specific number or qualification of "experts" is provided for this purpose.

4. Adjudication Method for the Test Set

As the "ground truth" is based on a laboratory analytical predicate method, an adjudication method (like 2+1, 3+1 typically used for discordant expert opinions) is not applicable. The comparison is between the new device's output and the predicate device's output. Any discrepancies would be investigated as part of the validation, not adjudicated through consensus of human readers.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC comparative effectiveness study was not done, as this is an IVD device and not an AI/ML diagnostic system requiring human interpretation as the primary endpoint. The device performs a laboratory test resulting in an electrophoretic pattern. The evaluation is on the accuracy of this pattern generation and its agreement with a predicate method, not on how human readers' diagnostic accuracy improves with or without an AI assist.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done

Yes, in a sense, a standalone performance was done. The device itself (HYDRAGEL 18 A1AT ISOFOCUSING kit on the HYDRASYS system) produces the electrophoretic patterns, which are then "evaluated visually." The core performance assessment is on the kit's ability to accurately produce these patterns, independent of human interpretation variability. The concordance study compares the patterns generated by the new device to those from the predicate device. While visual evaluation by a human is involved in reading the gels, the primary focus of the performance assessment is on the analytical capability of the device to produce patterns that are substantially equivalent to the predicate.

7. The Type of Ground Truth Used

The ground truth used is the results obtained from a legally marketed predicate device/method: polyacrylamide gel isoelectric focusing followed by Coomassie Blue staining, which is described as a "technique currently used in clinical diagnostic laboratories." This is essentially a "predicate analytical method" ground truth.

8. The Sample Size for the Training Set

The concept of a "training set" is not applicable for this type of conventional IVD submission. The device is a chemical reagent kit for a laboratory procedure, not an algorithm that learns from data.

9. How the Ground Truth for the Training Set Was Established

As there is no "training set" for this conventional IVD device, this question is not applicable.

Summary

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K063498

SEBIA Inc. Suite 400, 1705 Corporate Drive NORCROSS, GA 30093 USA

Tel: (770) 446 3707 - 3704 Fax: (770) 446 8511

510(k) Summary

Prepared: June 6, 2007

Applicant	SEBIA, INC.400-1705 corporate dr.Norcross, GA 30093
Manufacturer	SEBIAParc technologiqueLeonard de vinciRue Leonard de vinciCP 8010 Lisses, 91080 EVRYCedex, France
Submitter	SEBIA, INC
Address	400-1705 corporate dr.Norcross, GA 30093
Trade/proprietary Name	HYDRAGEL 18 A1AT ISOFOCUSING(PN 4356)
Common Names	Alpha-1 Antitrypsin phenotype Test
Classification name	Alpha-1 Antitrypsin phenotype Test
Classification number	21 CFR 866.5510. 21 CFR 866.5130

Device Description:

Intended Use:

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Substantial Equivalence Discussion:

For qualitative characterization of Alpha-1 antitrypsin phenotypes by isoelectric focusing and immunofixation with peroxidase labeled antiserum, the HYDRAGEL 18 A1AT ISOFOCUSING kit was compared to a predicate technique currently used in clinical diagnostic laboratories, which is based on polyacrylamide gel isoelectric focusing followed by staining of separated Alpha-1 antitrypsin isoforms with Coomassie Blue staining solution. These two techniques were found, experimentally and conceptually, substantially equivalent in assay principle, function, use, safety and effectiveness.

Parameters	Sebia	ARUP	SpecialtyLaboratories	UniversityofCalifornia, Medicalcenter
510(k)Number	Not Assigned	Don't have	Don't have	Don't have
Companyname	HYDRAGEL18 A1ATISOFOCUSINGkit	Alpha-1-AntitrypsinPhenotype	Alpha-1-Antitrypsin phenotyprwithout total AAT	Alpha-1-AntitrypsinPhenotypetest
Method	IsoelectricFocusing	Isoelectric Focusing/Immunoturbidimetric	IsoelectricFocusing	IsoelectricFocusing
Phenotypedetection	Yes	Yes	Yes	Yes
Results arequalitative	Yes	Yes	Yes	Yes
Samplecollected	Serum	Serum	Serum	Serum

In their concept and principle, and the techniques and the procedures used, the SEBIA HYDRAGEL 18 A1AT ISOFOCUSING tests are also similar to other products currently marketed in the USA, notably to SEBIA HYDRAGEL 3 & 9 CSF ISOFOCUSING kits.

HYDRASYS uses semi-automated electrophoresis system, such as described in the 510(k) premarket notification Ref. No. K033277 for which FDA clearance was issued on November 4, 2003

Assessment of Performance:

Performance study and comparisons of the HYDRAGEL 18 A1AT ISOFOCUSING KITS with polyacrylamide gels isoelectric focusing and comassie blue staining was done.

For Alpha-1 antitrypsin phenotypes characterization, the SEBIA HYDRAGEL 18 A1AT ISOFOCUSING in vitro diagnostic test is substantially equivalent to a predicate device, a polyacrylamide gel isoelectric focusing technique currently used in clinical diagnostic

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laboratories in the United States. Both tests are intended for qualitative analysis of Alpha-1 antitrypsin isoforms from human serum samples. All these products utilize isoelectric focusing to separate the isoforms on a suitable medium. The separated isoforms are then visualized by immunological reactions with a peroxidase labeled antiserum and a staining reagent or by Coomassie Blue staining solution. In both tests, the resulting patterns are evaluated visually.

Data are presented documenting substantial equivalency of the SEBIA and the polyacrylamide gel isoelectric focusing technique for Alpha-1 antitrypsin phenotype characterization. These devices were found experimentally and conceptually equivalent in assay principle, function, use, safety and effectiveness.

Other testing:

A Concordance study
B Within-gel reproducibility
C Gel-to-gel and lot-to-lot reproducibility
D Sensitivity study

Testing for Controls:

A- Validation testing:

-Reproducibility within gel and,

-Reproducibility between gels on 4 gels and on 12 gels.
B-Stability testing

Conclusion:

Performance studies of HYDRAGEL 18 A1AT ISOFOCUSING vielded satisfactory results in terms of concordance, reproducibility, sensitivity, validation and stability.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized image of an eagle with three bars extending from its head, resembling a symbol of strength and protection. The logo is black and white and appears to be a scanned image.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

SEBIA, Inc. c/o Ms. Karen Anderson Director, Technical and Regulatory 400-1705 Corporate Drive Norcross, GA 30093

JUN 1 1 2007

Re: K063498

Trade/Device Name: HYDRAGEL 18 A1AT ISOFOCUSING Kit and A1AT Controls Regulation Number: 21 CFR 866.5130 Regulation Name: Alpha-1-antitrypsin immunological test system Regulatory Class: Class II Product Code: OBZ, JJX Dated: June 5, 2007 Received: June 6, 2007

Dear Ms. Anderson:

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 iddions 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 Amendmonts, or to devices that have been reclassified in accordance with the provisions of the Federall Food, Dr w 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, IDA max 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 allows ou so begin marketing your device as described in your Section 510(k) premarket notification . The

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Page 2 -

FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0450. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR Part 807.97). 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 vours,

Robert R. Bockel

Robert L. Becker, Jr., M.D., PH.D. Director

Division of Immunology and Hematology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): K063498

Applicant: SEBIA, INC.

Device Name: HYDRAGEL 18 A1AT ISOFOCUSING (PN 4356)

INDICATIONS FOR USE:

The HYDRAGEL 18 A1AT ISOFOCUSING kit is designed for the qualitative detection and identification of the different phenotypes of Alpha-1 antitypsin (A1AT). Phenotyping results in conjunction with clinical findings and other laboratory assays aid in the diagnosis of Albha-1 antitrypsin deficiency The analysis is performed on human sera separated into electrophore is patterns ready for qualitative analysis. The procedure includes isoelectrofocusing on agaronorologio performed on the semi-automatic HYDRASYS system, followed by immunofixation ani-Alpha-1 antitrypsin antiserum. The use of enzyme labeled anti-Alpha-1 antitrypoin while ann enhanced the detection and identification of the different phenotypes.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of 1

ia. M. Chan

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) 063498

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510(k) Number (if known): K063498

Applicant: SEBIA, INC.

Device Name: A1AT CONTROLS (PN 4770)

INDICATIONS FOR USE:

For In Vitro Diagnostic Use.

Intended Use

The A1AT Controls are designed for the migration control of the human Alpha-1 antitrypsin isoforms pattern obtained with HYDRAGEL 18 A1AT ISOFOCUSING * isoelectric-focusing procedure. The A1AT Controls should be used as human sera.

Prescription Use__x AND/OR (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mara M Chan
Division Sign-Off

CHANA of In Intro Diagnostic ation and 5 riely

063498

Regulation Number and Section

§ 866.5130

Alpha -1-antitrypsin immunological test system.(a)
Identification. Analpha -1-antitrypsin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques thealpha -1-antitrypsin (a plasma protein) in serum, other body fluids, and tissues. The measurements aid in the diagnosis of several conditions including juvenile and adult cirrhosis of the liver. In addition,alpha -1-antitrypsin deficiency has been associated with pulmonary emphysema.(b)
Classification. Class II (performance standards).

SEBIA Inc. Suite 400, 1705 Corporate Drive NORCROSS, GA 30093 USA

510(k) Summary

Device Description:

Intended Use:

Substantial Equivalence Discussion:

Assessment of Performance:

Other testing:

Testing for Controls:

Conclusion:

510(k) Number (if known): K063498

Applicant: SEBIA, INC.

Device Name: HYDRAGEL 18 A1AT ISOFOCUSING (PN 4356)

INDICATIONS FOR USE:

Prescription Use X (Part 21 CFR 801 Subpart D)

510(k) Number (if known): K063498

Device Name: A1AT CONTROLS (PN 4770)

INDICATIONS FOR USE:

Intended Use

Prescription Use____x__ AND/OR (Part 21 CFR 801 Subpart D)

§ 866.5130

Prescription Use__x AND/OR (Part 21 CFR 801 Subpart D)