SPIFE A1AT kit

K213396 · Helena Laboratories, Corp. · OBZ · Oct 13, 2022 · Immunology

Device Facts

• Record ID: K213396
• Device Name: SPIFE A1AT kit
• Applicant: Helena Laboratories, Corp.
• Product Code: OBZ · Immunology
• Decision Date: Oct 13, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5130
• Device Class: Class 2

Intended Use

The SPIFE A1AT kit is designed for the qualitative detection of the different phenotypes of Alpha-1 Antitypsin (Al AT). 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 semiautomatic SPIFE Touch system followed by immunofixation with anti-Alpha-1 Antiserum. For in vitro diagnostic use only.

Device Story

The SPIFE A1AT kit is an in vitro diagnostic reagent system used for phenotyping Alpha-1 Antitrypsin (A1AT) in human serum. The device utilizes isoelectrofocusing on agarose gel to separate serum proteins into electrophoretic patterns. The process is performed on the semiautomatic SPIFE Touch system, followed by immunofixation using anti-Alpha-1 Antiserum. The system is intended for use by laboratory professionals in clinical settings. The resulting electrophoretic patterns are analyzed qualitatively to identify A1AT phenotypes. These results, when interpreted alongside clinical findings and other laboratory assays, assist clinicians in diagnosing Alpha-1 Antitrypsin deficiency, thereby guiding patient management and treatment decisions.

Clinical Evidence

No clinical data provided; the submission relies on bench testing and performance evaluation of the assay's ability to qualitatively detect A1AT phenotypes via isoelectrofocusing and immunofixation.

Technological Characteristics

The device consists of reagents for isoelectrofocusing on agarose gel and immunofixation with anti-Alpha-1 Antiserum. It is designed for use on the semiautomatic SPIFE Touch system. The technology relies on protein separation by isoelectric point followed by immunological identification. It is an in vitro diagnostic test system.

Indications for Use

Indicated for qualitative detection of Alpha-1 Antitrypsin phenotypes in human serum to aid in the diagnosis of Alpha-1 Antitrypsin deficiency in patients.

Regulatory Classification

Identification

An alpha-1-antitrypsin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the alpha-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.

Submission Summary (Full Text)

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October 13, 2022

Helena Laboratories, Corp. Rachel Easley Director, Regulatory Affairs 1530 Lindbergh Drive Beaumont, Texas 77707

Re: K213396

Trade/Device Name: SPIFE A1AT kit Regulation Number: 21 CFR 866.5130 Regulation Name: Alpha-1-Antitrypsin Immunological Test System Regulatory Class: Class II Product Code: OBZ Dated: April 27, 2022 Received: April 29, 2022

Dear Rachel Easley:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

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

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Ying Mao, Ph.D. Branch Chief Division of Immunology and Hematology Devices OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known) K213396

Device Name SPIFE A1AT Kit

## Indications for Use (Describe)

The SPIFE A1AT kit is designed for the qualitative detection of the different phenotypes of Alpha-1 Antitypsin (Al AT). 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 semiautomatic SPIFE Touch system followed by immunofixation with anti-Alpha-1 Antiserum. For in vitro diagnostic use only.

Type of Use (Select one or both, as applicable)

| <span style="text-decoration: overline;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) |
|------------------------------------------------------------------------------------------------|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |

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