MULTI-TEST II

K961918 · Lincoln Diagnostics, Inc. · SCL · Aug 7, 1996 · General Hospital

Device Facts

• Record ID: K961918
• Device Name: MULTI-TEST II
• Applicant: Lincoln Diagnostics, Inc.
• Product Code: SCL · General Hospital
• Decision Date: Aug 7, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5570
• Device Class: Class 2

Intended Use

The sole indication for Multi-Test II is for the percutaneous administration of diagnostic allergenic extracts.

Device Story

Multi-Test II is a device for percutaneous administration of diagnostic allergenic extracts. It is used by healthcare professionals in clinical settings to facilitate allergy testing. The device delivers extracts into the skin to elicit a diagnostic response. It functions as a single lumen needle/applicator system. The device is intended for prescription use only.

Clinical Evidence

No clinical data provided; substantial equivalence determination based on administrative review of device classification.

Technological Characteristics

Single lumen needle device for percutaneous administration. Classified under 21 CFR 880.5570 (Hypodermic single lumen needle).

Indications for Use

Indicated for percutaneous administration of diagnostic allergenic extracts in patients requiring allergy testing.

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.

Submission Summary (Full Text)

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FDA U.S. FOOD & DRUG ADMINISTRATION

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, [e-mail].

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

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
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
Trade Name: Multi-Test II
Regulatory Class: Unclassified
Product Code: LDH
Dated: May 16, 1996
Received: May 17, 1996

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 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 (Premarket Approval), 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 895. A 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 regulation may result in regulatory 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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or at [phone].

Sincerely yours,

Susan Pinnes
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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05/23/96 08:35 301 480 3002 FDA CDRH ODE 002
Page 1 of 1

510(k) Number (if known): K961918

Device Name: Multi-Test II

Indications For Use:

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-Off) Rebecca Crecente
Division of Dental, Infection Control, and General Hospital Devices
510(k) Number K961918

Prescription Use ☑
(Per 21 CFR 801.109)

OR

Over-The-Counter Use ☐
(Optional Format 1-2-96)

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