(81 days)
The device system is used for prick application of allergen extracts in the performance of skin testing.
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I am sorry, but the provided text is an FDA correspondence related to the classification of a medical device (AllerSharp™ Allergy Skin Tester) and does not contain information about acceptance criteria, device performance, study details, or ground truth establishment. Therefore, I cannot generate the requested table and paragraphs based on the given input.
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November 1, 2024
HMB Medical Concepts, Limited c/o Gavin McLachlan Vice President Quorum Allergy Products 2115 Wedgewood Way Santa Rosa, California 95404
Re: K011979
Trade/Device Name: AllerSharp™ Allergy Skin Tester Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic single lumen needle Regulatory Class: Class II Product Code: SCL
Dear Gavin McLachlan:
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 September 14, 2001. 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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SEP 1 4 2001
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
HMB Medical Concepts, Limited C/O Mr. Gavin McLachlan Vice President Ouorum Allergy Products 2115 Wedgewood Way Santa Rosa, California 95404
Re: K011979
Trade/Device Name: AllerSharp™ Allergy Skin Tester Regulation Number: None Regulation Name: Allergy Skin Test Device Regulatory Class: Unclassified Product Code: LDH Dated: June 5, 2001 Received: June 25, 2001
Dear Mr. McLachlan:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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
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Page 2 - Mr. McLachlan
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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (section 531-542 of the Act; 21); CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
signature
Timothy A Ulatows 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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Quorum Allergy Products 2115 Wedgewood Way Santa Rosa California 95404
Tel: 1-800 501 5115 Fax: 250 383 2230
September 10, 2001
Ms. Viola Hibbard Food and Drug Administration Center for Devices and Radiological Health Document Mail Center (HFZ-401) 1390 Piccard Drive Rockville, MD 20850
Indications For Use Statement AllerSharp Allergy Skin Testers
The device system is used for prick application of allergen extracts in the performance of skin testing.
Gavin McLachlan Quorum Allergy Products
Rultran Cicerite
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number Koll
§ 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).