The skin test applicator is used for conventional administration (percutaneous application of allergenic extracts directly onto the surface of the skin) of diagnostic allergen extracts for performing allergy skin tests on the typical sites (the back and the volar surfaces of the forearms) for hypersensitivity reactions in individuals suspected of having allergies.

The test tray is intended to hold allergenic extracts in a convenient arrangement for storage and use by the clinician.

Device Description

The AllergiEnd allergy skin testing products are supplied sterile and consist of two (2) devices:

Test Applicator
Test Tray

The MedScience AllergiEnd Applicator and Tray are used together for the conventional percutaneous application of substance directly onto the surface of the skin of diagnostic allergen extracts for performing skin tests for hypersensitivity reactions in individuals suspected of having allergies.

The AllergiEnd ST-9 Applicator has nine (9) test heads arranged in an asymmetrical design two (2) rows of four (4) test heads and a distal ninth test head. The test heads are labeled 1 through 9.

Each of the 9 test heads has a "leg." At the tip of each leg is an array of nine (9) protruding test points (tines). The tines utilize capillary action to hold the allergenic material for percutaneous delivery when the applicator is applied to the skin.

The test heads are designed to fit into the matching asymmetrical well design of the AllergiEnd ST-9 Test Tray. The applicator loads the allergen from each well in the tray on to each test head. The wells are numbered 1 to 9 to match the numbering on the applicator.

When properly applied to the skin, the applicator will leave visible indentations in the patient's skin corresponding to the 9 test heads of each applicator is not intended to pierce the skin.

The asymmetric design of the wells allows for only one possible orientation for the applicator to be placed in the tray. It is believed that the asymmetric design may help reduce the potential for operator error inherent in a symmetrical design and may also help the clinician avoid misreading of the skin reactions to the applied allergens.

The tray is configured to hold either 36 or 72 test allergens in individual wells. The groups of wells, either 4 groups for 36 test wells or 8 groups for 72 test wells, determine the tray configuration. The clinician's testing preferences will determine which tray configuration to consider.

The AllergiEnd ST-9 Multiple Well Test Tray is intended to hold small quantities of allergenic extracts in a convenient arrangement for storage and use. The Test Tray is not preloaded with allergens. The allergens are separately sourced and loaded by the clinician. Regardless of the number of wells, the test tray does not come in direct contact with the patient.

The individual wells are numbered with an easily readable alpha-numeric system to facilitate recording reactions to specific allergens. By including an alpha-numeric numbering system in the AllergiEnd ST-9 Multiple Well Test Tray the test administrator has a clear organizational structure for locating each allergen and tracking the patient's response and for correctly documenting in the patient's medical records.

The AllergiEnd ST-9 Multiple Well Test Tray also includes a locking lid that engages with a flexible seal. The locking/sealing cover protects the physician-filled allergenic material from contamination and evaporation. Additionally, the locking feature provides for secure handling. The locking feature does not affect the medical procedure, nor does it have any direct interaction with any of the allergenic extracts.

AI/ML Overview

This document describes the AllergiEnd® ST-9 Multiple Skin Test Applicator and Multiple Well Test Tray. The device is intended for the conventional percutaneous application of diagnostic allergen extracts for allergy skin tests.

Here's a breakdown of the acceptance criteria and supporting studies:

Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criterion	Reported Device Performance
Effectiveness: Ability to administer allergenic extract percutaneously to elicit reactions comparable to the predicate device.	Mean wheal diameters of histamine and control (glycerin saline) showed no statistically significant differences between the subject device and the predicate device.
Safety: Producing a comparable (or lower) sensation/pain rating as the predicate applicator when used to administer allergenic extract percutaneously.	The average pain rating for the AllergiEnd ST-9 Applicator was 1.54, which was comparable to the predicate device's pain rating of 1.55 (using the Wong-Baker FACES Pain Rating).
Biocompatibility: Acceptable biocompatibility for limited duration skin contact.	Cytotoxicity, sensitization, and irritation tests demonstrated acceptable biocompatibility.
Sterility: Sterility Assurance Level (SAL) of 10⁻⁶.	Sterilization validation (overkill approach, half-cycle method) achieved acceptance criteria.
Inspection: AQL level 1.0 sampling size.	Each lot is inspected at AQL level 1.0 sampling size. (While stated, no specific performance metrics provided for this criterion beyond compliance with inspection.)

Sample size used for the test set and the data provenance:
- Sample Size: 14 patients.
- Data Provenance: Prospective, single-site clinical study. The country of origin is not explicitly stated, but the submission is to the U.S. FDA, implying a U.S.-based study or one compliant with U.S. regulatory standards.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The document implies that the ground truth for "effectiveness" (wheal diameters) and "safety" (pain ratings) was established through direct measurement and patient reporting during a clinical study. It does not mention the use of external experts to establish a "ground truth" for the test set in the way one might for diagnostic accuracy; rather, it compares the device's performance to a predicate device and patient self-reported pain. Therefore, the concept of "experts" to establish ground truth in this context is not directly applicable as it would be for image interpretation tasks. The measurements (wheal diameter) are objective, and pain is subjective (patient-reported).
Adjudication method for the test set:
- The document does not describe an explicit adjudication method (like 2+1 or 3+1 consensus) for the clinical study. The effectiveness relied on comparing mean wheal diameters and pain ratings, which are quantitative measures rather than qualitative assessments requiring adjudication.
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:
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed. This device is an applicator system for allergy testing, not an AI-assisted diagnostic tool for human readers.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- No, this is a medical device, not an algorithm, and the performance is evaluated in direct user interaction for applying substances to the skin.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Effectiveness: The ground truth for effectiveness was established by measuring the mean wheal diameters resulting from the application of histamine and control solutions, compared directly to the predicate device's performance. This is an objective, physiological response.
- Safety: The ground truth for safety was established through patient self-reported pain ratings using the Wong-Baker FACES Pain Rating Scale.
The sample size for the training set:
- Not applicable. This device is a physical medical instrument, not an AI/ML algorithm requiring a training set.
How the ground truth for the training set was established:
- Not applicable, as it's not an AI/ML algorithm.

Summary

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MedScience Science Research Group, Inc. % Audrey Swearingen Director, Regulatory Affairs Emergo Global Consulting, LLC 2500 Bee Cave Road, Building 1, Suite 300 Austin, Texas 78746

November 1, 2024

Re: K172062

Trade/Device Name: AllergiEnd® ST-9 Multiple Skin Test Applicator. AllergiEnd® ST-9 Multiple Well Test Tray Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic single lumen needle Regulatory Class: Class II Product Code: SCL

Dear Audrey Swearingen:

The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated March 5, 2018. Specifically, FDA is updating this SE Letter because FDA has better categorized your device technology under product code SCL.

Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact David Wolloscheck, OHT3: Office of GastroRenal, OB-Gyn, General Hospital and Urology Devices, 301-796-1480. David.Wolloscheck@fda.hhs.gov.

Sincerely,

David Wolloscheck -S

David Wolloscheck, Ph.D. Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices and Human Factors OHT3: Office of GastroRenal, OB-Gyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

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Image /page/1/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym followed by the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out to the right of it. The full name of the agency is "U.S. Food & Drug Administration".

March 5, 2018

MedScience Science Research Group, Inc. % Audrey Swearingen Emergo Global Consulting, LLC 2500 Bee Cave Road, Building 1, Suite 300 Austin, Texas 78746

Re: K172062

Trade/Device Name: AllergiEnd® ST-9 Multiple Skin Test Applicator, AllergiEnd® ST-9 Multiple Well Test Tray Regulatory Class: Unclassified Product Code: LDH Dated: January 26, 2018 Received: January 29, 2018

Dear Audrey Swearingen:

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.

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.

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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 adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Tina Kiang
-s

Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K172062

Device Name

AllergiEnd® ST-9 Multiple Skin Test Applicator and AllergiEnd® ST-9 Multiple Well Test Tray

Indications for Use (Describe)

The test tray is intended to hold allergenic extracts in a convenient for storage and use by the clinician.

Type of Use (Select one or both, as applicable)
☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

K172062

1. Submission Sponsor

MedScience Research Group, Inc. 16469 Bridlewood Circle Delray Beach, Florida, 33445 USA

Marvin Smollar Co-president Email: marvin.smollar@medscienceinc.com Phone: 561-499-0411

2. Submission Correspondent

Emergo Global Consulting, LLC 2500 Bee Cave Road Building 1, Suite 300 Austin, TX 78746 USA

Office Phone: (512) 327-9997

Contact: Audrey Swearingen, RAC Title: Director, Regulatory Affairs

3. Date Prepared

01/25/2018

4. Device Identification

Trade/Proprietary Name:	AllergiEnd® ST-9 Multiple Skin Test ApplicatoAllergiEnd® ST-9 Multiple Well Test Tray
Common/Usual Name:	System, delivery, allergen and vaccine
Regulation Number:	None: Pre-Amendment
Product Code:	LDH
Device Class:	Unclassified
Classification Panel:	General Hospital

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5. Legally Marketed Predicate Device(s)

K003195, Greertrack Skin Testing System, currently marked by Greer under the brand name Skintestor OMNI™.

6. Indication for Use Statement

The test tray is intended to hold allergenic extracts in a convenient arrangement for storage and use by the clinician.

7. Device Description

The AllergiEnd allergy skin testing products are supplied sterile and consist of two (2) devices:

Test Applicator
Test Tray

The AllergiEnd ST-9 Applicator has nine (9) test heads arranged in an asymmetrical design two (2) rows of four (4) test heads and a distal ninth test head. The test heads are labeled 1 through 9.

When properly applied to the skin, the applicator will leave visible indentations in the patient's skin corresponding to the 9 test heads of each applicator is not intended to pierce the skin.

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8. Substantial Equivalence Discussion

The following table compares the Allergy skin testing device to the predicate device with respect to indications for use, principles of operation, technological characteristics, and materials. The subject devices do not raise any new issues of safety or effectiveness based on the similarities to the predicate device.

Manufacturer	MedScience	Greer Laboratories	Device Comparison
Trade Name	AllergiEnd ST-9 Applicatorand Tray	Greertrack Skin TestingSystem
	Applicator - Model 1000Tray - Models 1001-36 and 1001	Models: GT-IT, GT-IC
510(k) Number	TBD	K003195	N/A
Product Code	LDH	Same	Same
RegulationNumber	None: Pre-Amendment	Same	Same
Regulation Name	System, delivery, allergenand vaccine	Same	Same
Manufacturer	MedScience	Greer Laboratories
Trade Name	AllergiEnd ST-9 Applicatorand TrayApplicator - Model 1000Tray - Models 1001-36 and 1001	Greertrack Skin TestingSystemModels: GT-IT, GT-IC	Device Comparison
Indications for Use	The skin test applicator isused for conventionaladministration(percutaneous applicationof allergenic extractsdirectly onto the surface ofthe skin) of diagnosticallergen extracts forperforming allergy skintests on the typical sites(the back and the volarsurfaces of the forearms)for hypersensitivityreactions in individualssuspected of havingallergies.The test tray is intended tohold allergenic extracts in aconvenient arrangementfor storage and use by theclinician.	The device system is for usein the prick/punctureapplication of allergenextracts to the epicutaneouslayer of the skin in theperformance of skin testingfor immediate typehypersensitivity reactions inthose individuals suspectedof having allergies.	The proposedIndications for Use ismore descriptive.Does not raise anyadditional questionsof safety oreffectiveness.
Allergens	Not supplied: added byclinician	Same	Same
Target Population	The device is intended foruse by medicalprofessionals in a clinicalsetting.	Same	Same
Applicator
General Use	Application of doctorprovided allergenic extractsused for skin testing	Same	Same
Method forloading theallergenic material	Capillary action	Same	Same
Anatomicalsite/Location	Back and volar surface offorearms	Same	Same
Manufacturer	MedScience	Greer Laboratories
Trade Name	AllergiEnd ST-9 Applicatorand TrayApplicator - Model 1000Tray - Models 1001-36 and 1001	Greertrack Skin TestingSystemModels: GT-IT, GT-IC	Device Comparison
Material	Applicator is molded fromDupont Delrin®(polyoxymethylene)100P NC010.	Per spectral analysis, theapplicator is molded from athermoplastic polymeridentified aspolyoxymethylene orpolyacetal.	Both are made ofpolyoxymethylene.Any minor differencesin material does notraise any additionalquestions of safety oreffectiveness as theproposed materialwas found to bebiocompatible.
Applicator design	Rigid center spine thatincorporates the test headswith tines	Same	Same
Number ofapplicator heads	9	10	Number of applicatorheads does notprovide for afunctional difference,therefore it does notraise any additionalquestions of safety oreffectiveness.
Applicator Headpattern	Asymmetric9 test heads arranged in 2rows of 4 test heads with asingle test head distallylocated along the centerline of the applicator.	Symmetric5 rows of 2 heads.	The arrangement ofapplicator heads doesnot provide for afunctional difference;therefore, it does notraise any additionalquestions of safety oreffectiveness.
Spacing betweenHeads	20 mm	18.4 mm	The small increase inthe spacing betweenheads does notprovide for afunctional difference;therefore, it does notraise any additionalquestions of safety oreffectiveness.
Manufacturer	MedScience	Greer Laboratories	Device Comparison
Trade Name	AllergiEnd ST-9 Applicatorand TrayApplicator - Model 1000Tray - Models 1001-36 and 1001	Greertrack Skin TestingSystemModels: GT-IT, GT-IC	Device Comparison
Number of tineson each test head	9	7	The difference in thenumber of tines is notexpected to affectperformance orsafety.
Sterile	Ethylene Oxide (EO)	Same	Same
Single-Use	Yes	Same	Same
ApplicatorComplies with ISO10993-10	Yes	USP Class VI	Proposed device wastested per currentrequirements andshown to pass.
Tray
General Use	Holds small quantities ofdoctor-provided allergenicextracts and to allowallergens to be applied tothe applicator used for skintesting.	Same	Same
Tray pattern	Matches that of applicator	Same	Same
Number of traywells	Catalogue# 1001-36has 36 wellsCatalogue# 1001has 72 wells	20 - three trays may becombined to have 60 wells	The number of testwells does not providefor a functionaldifference; therefore,it does not raise anyadditional questionsof safety oreffectiveness.
Sterile	Ethylene Oxide (EO)	Same	Same
Single Use	No	No	Same
MaterialComposition	Rohm Plexiglas®Plexiglas SG 10 acrylic	Per spectral analysis, thetray is molded fromPolymethyl methacrylate(commonly referred to asacrylic).	Difference in materialdoes not raise anyadditional questionsof safety oreffectiveness as theproposed materialwas found to bebiocompatible.
Manufacturer	MedScience	Greer Laboratories
Trade Name	AllergiEnd ST-9 Applicatorand TrayApplicator - Model 1000Tray - Models 1001-36 and 1001	Greertrack Skin TestingSystemModels: GT-IT, GT-IC	Device Comparison
Lid Function	Locking	No Lid	Lid decreases chancefor contamination.More securelyintegrates the testwells with the cover toform a sturdier deviceallowing for moresecure handling.Does not raise anyadditional questionsof safety oreffectiveness.
ApplicatorComplies with ISO10993-10	Yes	USP Class VI	Proposed device wastested per currentrequirements.

Table 5A – Comparison of Characteristics

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9. Non-Clinical Performance Data

Each lot of the AllergiEnd® ST-9 Multiple Skin Test Applicator and Multiple Well Test Tray are inspected at AQL level 1.0 sampling size.

The following data were provided in support of the substantial equivalence determination:

Biocompatibility Testing

Biocompatibility evaluation of the AllergiEnd® ST-9 Multiple Skin Test Applicator was conducted in accordance with the FDA Guidance Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" April 23, 2013, and International Standard ISO 10993-1 Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a Risk Management Process, as recognized by FDA.

The AllergiEnd® ST-9 Multiple Skin Test Applicator contacts intact skin for limited duration (< 10 seconds under normal use). The following tests were performed:

. Cytotoxicity
. Sensitization
Irritation

The results of testing demonstrate acceptable biocompatibility of the device.

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Sterilization Testing

Sterilization validation was conducted using an overkill approach (half-cycle method) in accordance with ISO 11135:2014.

The sterility assurance level (SAL) is 10 °. Test results demonstrated that acceptance criteria were met.

10. Clinical Performance Data

Clinical testing of the AllergiEnd® ST-9 Multiple Skin Test Applicator and Multiple Well Test Tray was conducted to establish equivalence to the predicate device through side-by-side testing.

Comparative Device Study

The study included 14 patients at a single site. The test locations on the body were divided into right and left sides of the test subject. The AllergiEnd ST-9 applicators were applied on the left side of the subject. The predicate applicators were applied on the right side of the subject. Eight applicators were used for each test subject. The AllergiEnd ST-9 (a 9-head applicator) had a total of four applications in each test; two using histamine applied to each test head, for a total of 18 locations tested with histamine and 2 using the glycerin saline solution applied to each test head, for a total of 18 locations tested with the control glycerin saline. The Greer Skintestor OMNI (a 10-head applicator) also had a total of four applications in each test; two using histamine applied to each test head, for a total of 20 locations tested with histamine and 2 using the glycerin saline solution applied to each test head, for a total of 20 locations tested with the control glycerin saline solution.

Primary effectiveness endpoint:

The subject device is able to administer allergenic extract percutaneously to elicit reactions comparable to predicate.

Primary safety endpoint:

The applicator of the subject device produces a comparable (or lower) sensation/pain rating as the predicate applicator when used to administer allergenic extract percutaneously.

Effectiveness:

Mean wheal diameters of the histamine and the control, glycerin saline were compared. In comparing the subject and predicate devices, there were no statistically significant differences.

Safety:

The average pain reading for AllergiEnd ST-9 Applicator, using the Wong-Baker FACES Pain Rating, was 1.54, which was comparable to the predicate device's Pain Rating of 1.55.

Summary

Mean wheal diameters were compared showing no statistically significant differences of allergen delivery between subject and predicate devices. Pain assessment, using the Wong-Baker FACES Pain Rating Scale, showed no significant differences between ST-9 and Greer applicators. The data supports the clinical use of the device.

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11. Conclusions and Statement of Substantial Equivalence

A combination of bench-testing, clinical testing, as well as feature comparison, demonstrate that the AllergiEnd® ST-9 Multiple Skin Test Applicator and Multiple Well Test Tray is substantially equivalent to the predicate device.

Regulation Number and Section

§ 880.5570 Hypodermic single lumen needle.

(a)
Identification. A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set.(b)
Classification. Class II (performance standards).