Steroid 21-Hydroxylase Antibody (21-OHAb) ELISA Kit

K180607 · Kronus, Inc. · PCG · Nov 23, 2018 · Immunology

Device Facts

• Record ID: K180607
• Device Name: Steroid 21-Hydroxylase Antibody (21-OHAb) ELISA Kit
• Applicant: Kronus, Inc.
• Product Code: PCG · Immunology
• Decision Date: Nov 23, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5660
• Device Class: Class 2

Intended Use

The KRONUS Steroid 21-Hydroxylase Autoantibody (21-OHAb) ELISA Kit is for the qualitative determination of antibodies to steroid 21-hydroxylase (21-OH) in human serum. The Steroid 21-Hydroxylase Autoantibody (21-OHAb) ELISA Kit is useful as an aid in the diagnosis of autoimmune adrenal disease, whether expressed as autoimmune Addison's disease (isolated) or Addison's disease as part of the more complex autoimmune polyglandular syndrome (APS), type I or II. The assay result is to be used in conjunction with other clinical and laboratory findings and is not a substitute for functional testing required to diagnose adrenal insufficiency.

Device Story

Manual ELISA kit; detects steroid 21-hydroxylase autoantibodies in human serum. Principle: divalent autoantibodies bridge 21-OH coated on microtiter plate wells and liquid-phase 21-OH-biotin; detected via streptavidin-peroxidase and TMB chromogenic substrate. Output: absorbance measured at 450 nm; index value calculated relative to reference preparation. Used in clinical laboratories by trained personnel. Results aid diagnosis of autoimmune adrenal disease; must be used with other clinical/laboratory findings; not a substitute for functional adrenal testing.

Clinical Evidence

Clinical validation performed on 399 patient serum samples (108 with autoimmune adrenal disease, 291 with other autoimmune/non-infectious conditions). Clinical sensitivity: 87.0% (94/108; 95% CI: 79.4%–92.2%). Clinical specificity: 99.3% (289/291; 95% CI: 97.5%–99.8%). Method comparison with RIA predicate (N=254) showed 98.9% positive percent agreement and 96.9% negative percent agreement.

Technological Characteristics

Manual ELISA; 96-well microtiter plate coated with recombinant human 21-OH. Energy source: external plate reader (450 nm). Materials: recombinant 21-OH, biotinylated 21-OH, streptavidin-peroxidase, TMB substrate, H2SO4 stop solution. Qualitative assay; index-based interpretation. No connectivity; standalone manual test.

Indications for Use

Indicated for qualitative detection of steroid 21-hydroxylase autoantibodies in human serum to aid in diagnosis of autoimmune adrenal disease (isolated Addison's disease or APS type I/II). For prescription use only.

Regulatory Classification

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).

Predicate Devices

• KRONUS Steroid 21-Hydroxylase Autoantibody (21-OHAb) ELISA Kit (K063566)

Submission Summary (Full Text)

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November 23, 2018

KRONUS, Inc. Brian Deis Quality Control and Regulatory Compliance Manager 170 S. Seneca Springs Way Suite 105 Star, Idaho 83669

Re: K180607

Trade/Device Name: KRONUS Steroid 21-Hydroxylase Antibody (21-OHAb) ELISA Kit Regulation Number: 21 CFR 866.5660 Regulation Name: Multiple autoantibodies immunological test system Regulatory Class: Class II Product Code: PCG Dated: March 1, 2018 Received: March 7, 2018

Dear Brian Deis:

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

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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 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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

## Leonthena R. Carrington -S

Lea Carrington Director Division of Immunology and Hematology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known) K180607

Device Name

KRONUS Steroid 21-Hydroxylase Autoantibody (21-OHAb) ELISA Kit

Indications for Use (Describe)

The KRONUS Steroid 21-Hydroxylase Autoantibody (21-OHAb) ELISA Kit is for the qualitative determination of antibodies to steroid 21-hydroxylase (21-OH) in human serum. The Steroid 21-Hydroxylase Autoantibody (21-OHAb) ELISA Kit is useful as an aid in the diagnosis of autoimmune adrenal disease, whether expressed as autoimmune Addison's disease (isolated) or Addison's disease as part of the more complex autoimmune polyglandular syndrome (APS), type I or II. The assay result is to be used in conjunction with other clinical and laboratory findings and is not a substitute for functional testing required to diagnose adrenal insufficiency.

| Type of Use (Select one or both, as applicable) | |
|-----------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------|
| <span> <span style="text-decoration: overline;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> | <span> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </span> |

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