(62 days)
Not Found
Not Found
No
The device description and performance studies focus on mechanical components and clinical comparability, with no mention of AI or ML.
No
The device is used for diagnostic purposes (skin testing for allergies) and does not provide therapy or treatment for a disease or condition.
Yes
The device is used in the performance of skin testing for immediate type hypersensitivity reactions, which is a diagnostic procedure to identify allergies.
No
The device description explicitly states that the device system is comprised of both single-use and reusable components, including physical hardware like a plastic Track, a reusable Handle, and a reusable Loading Tray.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, tissue) to provide information for diagnostic purposes.
- Device Function: This device is used for the application of allergen extracts to the skin (in vivo), not for the examination of specimens from the body (in vitro). It's a tool for performing a skin test, which is a clinical procedure, not an in vitro laboratory test.
- Intended Use: The intended use clearly states "prick/puncture application of allergen extracts The epicutaneous layer of the skin in the performance of skin testing". This describes an in vivo application.
- Device Description: The components described (Tracks, Handle, Loading Tray) are designed for the physical application of substances to the skin.
- Performance Study: The performance study involves applying substances to individuals' skin and measuring the resulting reactions (erythema and wheal), which is an in vivo assessment.
Therefore, this device is a medical device used in a clinical setting for an in vivo diagnostic procedure (skin testing), but it does not meet the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The device system is for use in the prick/puncture application of allergen extracts to the epicutaneous layer of the skin in the performance of skin testing for immediate type hypersensitivity reactions in those individuals suspected of having allergies.
Product codes (comma separated list FDA assigned to the subject device)
SCL
Device Description
The device system is comprised of both single-use and reusable components. The device includes:
-
- 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.
-
- 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.
-
- A reusable polystyrene plastic Loading Tray designed to hold one Handle with attached Tracks, and eight vials of allergen extracts.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
The device is intended for the application of allergen/control extracts to the typical sites used in the performance of allergy skin testing (volar surface of the arms and back).
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Intended for use in physician clinic setting and/or hospital. The device is intended for use by medical professionals in the testing of individuals suspected of having allergies.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
To verify the qualitative comparability of the GreerTRACK to the GreerPICK in the performance of the application of skin test materials, both devices were tested side-by-side 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.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
GreerPICK (DermaPICK) Skin Test Device
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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
1
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
2
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
2
Enclosure
3
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
- 1748 400 Division of Den. and General Hospia 510(k) Number --
(Optional Format 3-10-98)
3
4
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:
-
- 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.
-
- 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.
-
- 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®
5
| GreerTRACK | TARGET POPULATION
The device is intended for use by medical professionals in the testing of
individuals suspected of having allergies. |
|------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| GreerPICK | The device is intended for use by medical professionals in the testing of
individuals suspected of having allergies. |
| GreerTRACK | DESIGN
The device is designed to apply 8 allergen/control extracts
simultaneously. |
| GreerPICK | The device is designed to individually apply allergen/control extracts. |
| GreerTRACK | MATERIAL
thermoplastic polymer. |
| GreerPICK | thermoplastic polymer. |
| GreerTRACK | PERFORMANCE
The device introduces allergens/controls through prick/puncture of the
epicutaneous layer of the skin. |
| GreerPICK | The device introduces allergens/controls through prick/puncture of the
epicutaneous layer of the skin. The device can also be used to "scratch"
the surface of the skin to introduce the allergen/control. |
| GreerTRACK | STERILITY
The product is terminally sterilized by gamma irradiation. |
| GreerPICK | The product is terminally sterilized by ethylene oxide (ETO) exposure. |
| GreerTRACK | BIOCOMPATIBILITY
Epicutaneous contact only, not intended for implantation; the material
has been tested to meet USP Class VI criteria. |
| GreerPICK | Epicutaneous contact only, not intended for implantation; the material
has been tested to meet USP Class VI criteria. |
| GreerTRACK | ANATOMICAL SITES
The device is intended for the application of allergen/control extracts to
the typical sites used in the performance of allergy skin testing (volar
surface of the arms and back). |
| GreerPICK | The device is intended for the application of allergen/control extracts to
the typical sites used in the performance of allergy skin testing (volar
surface of the arms and back). |
| GreerTRACK | WHERE USED
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
:
6
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.