GREERTRACK SKIN TESTING SYSTEM, MODEL GT-IT, GT-IC

K003195 · Greer Laboratories, Inc. · SCL · Dec 13, 2000 · General Hospital

Device Facts

• Record ID: K003195
• Device Name: GREERTRACK SKIN TESTING SYSTEM, MODEL GT-IT, GT-IC
• Applicant: Greer Laboratories, Inc.
• Product Code: SCL · General Hospital
• Decision Date: Dec 13, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5570
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

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.

Device Story

GreerTRACK Skin Testing System facilitates prick/puncture application of allergen extracts into the epicutaneous skin layer. System components: sterile, single-use, injection-molded thermoplastic polymer 'Track' (four sites, four tines each); reusable handle (plastic body, stainless steel screws/spring, metal trigger/latch); reusable polystyrene loading tray. Used in physician clinics or hospitals by medical professionals. Clinician loads allergen extracts into tray, attaches Tracks to handle, and applies to patient skin (volar surface of arms or back). Device enables simultaneous application of eight allergen/control extracts. Output is a skin reaction (wheal/erythema) used by clinicians to diagnose hypersensitivity. Benefits include standardized, efficient, multi-site allergen delivery compared to individual application methods.

Clinical Evidence

Bench testing and comparative clinical performance study. Study involved 12 individuals comparing GreerTRACK to GreerPICK using histamine (positive control) and glycerosaline (negative control). GreerTRACK performed 46 applications per solution; GreerPICK performed 19. Primary endpoints: measurements of largest and orthogonal diameters for erythema and wheal reactions. Results showed GreerTRACK elicited reactions comparable to GreerPICK, with clear distinguishability between positive, negative, and 10-fold diluted positive controls.

Technological Characteristics

System consists of single-use thermoplastic polymer Tracks and reusable handle (plastic, stainless steel, metal trigger). Tracks are injection-molded and meet USP Class VI biocompatibility criteria. Sterilization: Gamma irradiation. Form factor: Multi-site (8-site) applicator. Connectivity: None (mechanical device).

Indications for Use

Indicated for individuals suspected of having allergies, including adults and children, for the performance of skin testing to detect immediate type hypersensitivity reactions.

Regulatory Classification

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.

Predicate Devices

• GreerPICK (DermaPICK) Skin Test Device

Submission Summary (Full Text)

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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 [phone]. 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 [phone] 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

2

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:

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.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Patacio Vincente

1. 1748 400 Division of Den. and General Hospia 510(k) Number --

(Optional Format 3-10-98)

3

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K003195

DEC 1 3 2000

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

S
(104) SUMMARY

#### 510(k) SUMMARY

Submitter:

Greer Laboratories, Inc. 639 Nuway Circle NE Lenoir, NC 28645 phone: [phone] fax: [phone]

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.
- 2) 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.
- 3) 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 POPULATION<br>The device is intended for use by medical professionals in the testing of<br>individuals suspected of having allergies. |
|------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| GreerPICK | The device is intended for use by medical professionals in the testing of<br>individuals suspected of having allergies. |
| GreerTRACK | DESIGN<br>The device is designed to apply 8 allergen/control extracts<br>simultaneously. |
| GreerPICK | The device is designed to individually apply allergen/control extracts. |
| GreerTRACK | MATERIAL<br>thermoplastic polymer. |
| GreerPICK | thermoplastic polymer. |
| GreerTRACK | PERFORMANCE<br>The device introduces allergens/controls through prick/puncture of the<br>epicutaneous layer of the skin. |
| GreerPICK | The device introduces allergens/controls through prick/puncture of the<br>epicutaneous layer of the skin. The device can also be used to "scratch"<br>the surface of the skin to introduce the allergen/control. |
| GreerTRACK | STERILITY<br>The product is terminally sterilized by gamma irradiation. |
| GreerPICK | The product is terminally sterilized by ethylene oxide (ETO) exposure. |
| GreerTRACK | BIOCOMPATIBILITY<br>Epicutaneous contact only, not intended for implantation; the material<br>has been tested to meet USP Class VI criteria. |
| GreerPICK | Epicutaneous contact only, not intended for implantation; the material<br>has been tested to meet USP Class VI criteria. |
| GreerTRACK | ANATOMICAL SITES<br>The device is intended for the application of allergen/control extracts to<br>the typical sites used in the performance of allergy skin testing (volar<br>surface of the arms and back). |
| GreerPICK | The device is intended for the application of allergen/control extracts to<br>the typical sites used in the performance of allergy skin testing (volar<br>surface of the arms and back). |
| GreerTRACK | WHERE USED<br>Intended 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.