The device system is for use in the prick/puncture application of allergen extracts The epicutaneous layer of the skin in the performance of skin testing for immediate type hypersensitivity reactions in those individuals suspected of having allergies.

Prick/puncture application of multiple allergen extracts in the performance of skin testing for immediate type hypersensitivity reactions in those individuals suspected of having allergies.

Device Description

The device system is comprised of both single-use and reusable components. The device includes:

1. The Track a sterile, single-use, injection molded, plastic piece with four sites having four tines each, intended to deliver the allergens into the epicutaneous layer of the skin. The Track is injection molded from a thermoplastic polymer. The material has been tested to meet USP Class VI performance criteria for biocompatibility. The Tracks are packaged in a PETG tray sealed with a tyvek lid, eight Tracks per tray.
1. A reusable Handle designed to "pick-up" and hold one or two Tracks. The Handle is constructed of a plastic body, stainless steel metal screws, and spring, and a machined, extruded metal trigger/latch mechanism designed to engage and hold the Tracks.
1. A reusable polystyrene plastic Loading Tray designed to hold one Handle with attached Tracks, and eight vials of allergen extracts.

AI/ML Overview

A. Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Stated)	Reported Device Performance and Study Results
The GreerTRACK should elicit comparable reactions to the GreerPICK when applying skin test materials.	"Results confirm that testing with the GreerTRACK elicits comparable reactions to those elicited by the GreerPICK." The study measured the largest and orthogonal diameters for both erythema and wheal reactions for both devices, and these measurements were found to be comparable.
The GreerTRACK should elicit a reaction to a 10-fold dilution of the positive control (histamine).	"As for the GreerPICK, the GreerTRACK can elicit a reaction to a 10-fold dilution of the positive control that is intermediate between the positive and negative controls." The study used histamine at 5 and 0.5 mg/mL as positive controls, and the GreerTRACK demonstrated the ability to differentiate these concentrations.
The reaction from the positive control dilution should be intermediate between positive and negative controls.	"As for the GreerPICK, the GreerTRACK can elicit a reaction to a 10-fold dilution of the positive control that is intermediate between the positive and negative controls." The study successfully showed this differentiation using histamine (positive control) and glycerosaline (negative control).
The reaction from the positive control dilution should be clearly distinguishable from the negative control.	"As for the GreerPICK, the GreerTRACK can elicit a reaction to a 10-fold dilution of the positive control that is intermediate between the positive and negative controls, and is clearly distinguishable from the reaction associated with the negative control." The study confirmed the distinctness of the positive control reaction from the negative control.

B. Sample sizes used for the test set and the data provenance

Sample Size (Test Set): 12 individuals.
Data Provenance: Not specified, but generally, clinical trials for FDA submissions are prospective and conducted in the country of origin (likely the USA given the FDA submission).

C. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided in the document. The document describes measurements taken of skin reactions (erythema and wheal), which are objective measurements, but it doesn't explicitly state who performed these measurements or their qualifications, nor does it specify if multiple experts established a "ground truth" through consensus for these measurements.

D. Adjudication method for the test set

This information is not provided in the document. The document mentions measurements were "made and tabulated" but does not detail any adjudication process for these measurements.

E. 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. This was not an AI device, and therefore, an MRMC study related to AI assistance was not conducted. This study compares two medical devices (GreerTRACK vs. GreerPICK) for skin allergy testing.

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

Not applicable. This device is a manual skin testing system, not an algorithm, so a standalone algorithm performance study was not conducted.

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

The ground truth was established by direct clinical observation and measurement of physiological reactions (erythema and wheal sizes) to standardized positive (histamine at different concentrations) and negative (glycerosaline) controls. This is essentially an objective, measured response to known stimuli, rather than an "expert consensus" on a diagnosis, pathology, or long-term outcomes data in this context. The expectation is that histamine causes a reaction and glycerosaline does not.

H. The sample size for the training set

Not applicable. This device is a physical medical device, not a machine learning algorithm, and thus does not have a "training set" in the context of AI.

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

Not applicable. As there is no training set for this physical medical device, there is no ground truth established for it.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services USA logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

November 1, 2024

Greer Laboratories, Incorporated Gerald Friesen Vice President of Quality 639 Nuway Circle, Northeast P.O. Box 800 Lenoir, North Carolina 28645-0800

Re: K003195

Trade/Device Name: GreerTRACK Skin Testing System Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic single lumen needle Regulatory Class: Class II Product Code: SCL

Dear Gerald Friesen:

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 December 13, 2000. 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.

Sincerelv.

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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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image is a seal for the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle with its wings spread.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 3 2000

Mr. Gerald Friesen Vice President of Quality Greer Laboratories, Incorporated 639 Nuway Circle, Northeast P.O. Box 800 Lenoir, North Carolina 28645-0800

K003195 Re : GreerTRACK Skin Testing System Trade Name: Unclassified Regulatory Class: LDH Product Code: 2000 October 11, Dated: October 12, 2000 Received:

Dear Mr. Friesen:

We have reviewed your Section 510(k) notification of intent to We have reviewed your bection brown and we have determined the market the for market the device referenced above (for the indications for device is substancially equature) to legally marketed were 28 use stated in the encrosate, commerce prior to May 28, 1976, devices marketed in theerbace al Device Amendments, or to the enactment date of the nassified in accordance with the devices that have been recrabblians of Cosmetic Act (Act). provisions of the rederal took, subject to the general The general controls controls provisions of the Act. controls provisions of cho include requirements for annual provisions of the Act Includes, good manufacturing practice, registration, firsting or acainst misbranding and adulteration.

If your device is classified (see above) into either class II), it may If your device is crabblied (so(Premarket Approval), it may (Special Controls) or class i controls. Existing major be subject to such addicional can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ಕ್ಕಿ rederal Regulations, freis and somes compliance with Substantly equivalence aring Practice requirements, as set the Current Cood namesustem Regulation (QS) for Medical rorth in the Quarrey Bytion (21 CFR Part 820) and that, Devices. Ocheral QS inspections, the Food and Drug through perrodic go inbpoority such assumptions. Failure to Administracton (rbi) wirl toon may result in regulatory comply with the ont regainmay publish further announcements accion. In addression in the Federal Register. Please note: concerning your device in enket notification submission does chis response to your promobility have under sections 531 not arrect any obligation for devices under the Electronic

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Page 2 - Mr. Friesen

Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as This lecter will arrows) ) a premarket notification.
described in your 510 (k) premarket not sour dayigo The FDA described in your 510(K) prematice of your device to a legally marketed predicate device results in a classification for your marketed predicate device rebares in a spoceed to the market.

If you desire specific advice for your device on our labeling if you desire specific advice additionally 809.10 for in regulation (21 cm Fare ovi and contact the Office of compliance at (301) 594-4692. Additionally, for questions on Compliance at (301) 534 size: for your device, please contact the promotion and advertibing of Jour and Submittee of Complease note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general premarket notification - (zich ities under the Act may be information on your responsible and Manufacturers Assistance obtained from the bivision of billing (801) 443-6597 or at its internet address

"http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours

Timothy A. Ulatowski
Director

Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page

510(k) Number (if known): 长ወ o 3/9 ≤

Device Name: GreerTRACK Skin Testing System

Indications For Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Patacio Vincente

1748 400 Division of Den. and General Hospia 510(k) Number --

(Optional Format 3-10-98)

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K003195

DEC 1 3 2000

Image /page/4/Picture/2 description: The image is a logo for Greer Laboratories, Inc. The logo features a black square with rounded corners on the left side, inside of which is a white Erlenmeyer flask. To the right of the square is the word "GREER" in large, bold, black letters, and below that is the text "LABORATORIES, INC." in smaller, black letters.

POST OFFICE BOX 800 · 639 NUWAY CIRCLE · LENOIR, NORTH CAROLINA 28645 U.S.A. PHONE: 828/754-5327 or 800/438-0088 • FAX: 828/754-5320 www.greerlabs.com

S
(104) SUMMARY

510(k) SUMMARY

Submitter:

Greer Laboratories, Inc. 639 Nuway Circle NE Lenoir, NC 28645 phone: (828) 754-5327 fax: (828) 754-5320

Contact:

Date:

Device Name:

Common/ Classification Name:

Predicate Device:

Description:

10 October, 2000

Vice President, Quality

Gerald Friesen, PharmD

GreerTRACK Skin Testing System

System, Delivery, Allergen and Vaccine

GreerPICK (DermaPICK) Skin Test Device

The device system is comprised of both single-use and reusable components. The device includes:

1. The Track a sterile, single-use, injection molded, plastic piece with four sites having four tines each, intended to deliver the allergens into the epicutaneous layer of the skin. The Track is injection molded from a thermoplastic polymer. The material has been tested to meet USP Class VI performance criteria for biocompatibility. The Tracks are packaged in a PETG tray sealed with a tyvek lid, eight Tracks per tray.
1. A reusable Handle designed to "pick-up" and hold one or two Tracks. The Handle is constructed of a plastic body, stainless steel metal screws, and spring, and a machined, extruded metal trigger/latch mechanism designed to engage and hold the Tracks.
1. A reusable polystyrene plastic Loading Tray designed to hold one Handle with attached Tracks, and eight vials of allergen extracts.

Prick/puncture application of multiple allergen extracts in the performance of skin testing for immediate type hypersensitivity reactions in those individuals suspected of having allergies.

Intended Use:

Pride in Excellence®

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GreerTRACK	TARGET POPULATIONThe device is intended for use by medical professionals in the testing ofindividuals suspected of having allergies.
GreerPICK	The device is intended for use by medical professionals in the testing ofindividuals suspected of having allergies.
GreerTRACK	DESIGNThe device is designed to apply 8 allergen/control extractssimultaneously.
GreerPICK	The device is designed to individually apply allergen/control extracts.
GreerTRACK	MATERIALthermoplastic polymer.
GreerPICK	thermoplastic polymer.
GreerTRACK	PERFORMANCEThe device introduces allergens/controls through prick/puncture of theepicutaneous layer of the skin.
GreerPICK	The device introduces allergens/controls through prick/puncture of theepicutaneous layer of the skin. The device can also be used to "scratch"the surface of the skin to introduce the allergen/control.
GreerTRACK	STERILITYThe product is terminally sterilized by gamma irradiation.
GreerPICK	The product is terminally sterilized by ethylene oxide (ETO) exposure.
GreerTRACK	BIOCOMPATIBILITYEpicutaneous contact only, not intended for implantation; the materialhas been tested to meet USP Class VI criteria.
GreerPICK	Epicutaneous contact only, not intended for implantation; the materialhas been tested to meet USP Class VI criteria.
GreerTRACK	ANATOMICAL SITESThe device is intended for the application of allergen/control extracts tothe typical sites used in the performance of allergy skin testing (volarsurface of the arms and back).
GreerPICK	The device is intended for the application of allergen/control extracts tothe typical sites used in the performance of allergy skin testing (volarsurface of the arms and back).
GreerTRACK	WHERE USEDIntended for use in physician clinic setting and/or hospital.
GreerPICK	Intended for use in physician clinic setting and/or hospital

Technological Charateristics: Comparison to Predicate Device

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Clinical Performance

To verify the qualitative comparability of the GreerPICK to the GreerPICK in the performance of the application of skin test materials, both devices were tested side-byside using histamine as the positive control, and glycerosaline as the negative control. Twelve (12) individuals had a total of 46 applications each of histamine, at both 5 and 0.5 mg/mL, and glycerosaline using the GreerTRACK. The same individuals also had a total of 19 applications of each solution using the GreerPICK. Measurements of the largest and orthogonal diameters for both the erythema and wheal reactions were made and tabulated. The sums of these reactions were calculated as were the overall means and standard deviations for the reactions measured for each test solution.

Conclusions

Results confirm that testing with the GreerTRACK elicits comparable reactions to those elicited by the GreerPICK. As for the GreerPICK, the GreerTRACK can elicit a reaction to a 10 fold dilution of the positive control that is intermediate between the positive and negative controls, and is clearly distinguishable from the reaction associated with the negative control.

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).