(82 days)
The sole indication for Multi-Test II is for the percutaneous administration of diagnostic allergenic extracts.
Not Found
I am sorry, but based on the provided document, I cannot answer the question regarding acceptance criteria and the study that proves the device meets those criteria. The provided text is a 510(k) clearance letter from the FDA for the "Multi-Test II" device, classifying it as a Class II hypodermic single lumen needle used for the percutaneous administration of diagnostic allergenic extracts.
This document confirms the device's regulatory classification and that it is substantially equivalent to devices marketed before May 28, 1976. However, it does not include any information about performance criteria, study designs, sample sizes, expert qualifications, or ground truth establishment relevant to the device's performance characteristics.
The letters explicitly state:
- "Please note that the 510(k) submission was not re-reviewed." (Page 0)
- "We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent... " (Page 1)
This implies that the FDA's decision was based on a comparison to a predicate device, not necessarily on a detailed presentation of new performance study data against specific acceptance criteria in the provided document. To find the information requested, I would need access to the actual 510(k) submission document, which would typically contain such study details.
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Lincoln Diagnostics, Incorporated Gary L. Hein President Hickory Point Road, Box 1128 Decatur, Illinois 62525
November 1, 2024
Re: K961918
Trade/Device Name: Multi-Test II Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic single lumen needle Regulatory Class: Class II Product Code: SCL
Dear Gary L. Hein:
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 August 7, 1996. 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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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG - 7 1996
Mr. Gary L. Hein President Lincoln Diagnostics, Incorporated Hickory Point Road Box 1128 Decatur, Illinois 62525
Re : K961918 Multi-Test II Trade Name: Requlatory Class: Unclassified Product Code: LDH Dated: May 16, 1996 May 17, 1996 Received:
Dear Mr. Hein:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਸ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP. requlation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Mr. Hein
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) 594-4639. 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or at (301) 443-6597.
Sincerely yours,
Susan Tunner
Timothy A. Ulatowski Acting 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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0002
Page 1 ol 1
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: _________________________________________________________________________________________________________________________________________________________________ Multi-Test II
Indications For Use:
08:35
The sole indication for Multi-Test II is for the percutaneous administration of diagnostic allergenic extracts.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE) (Division Sign-O Division of Dec and General Hor 510(k) Number Prescription Use OR Over-The-Counter Use (Per 21 CFR 801.109)
(Optional Format 1-2-96)
§ 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).