N-ASSAY TIA C1-INACTIVATOR TEST KIT

K965024 · Crestat Diagnostics, Inc. · DBA · Jul 14, 1997 · Immunology

Device Facts

• Record ID: K965024
• Device Name: N-ASSAY TIA C1-INACTIVATOR TEST KIT
• Applicant: Crestat Diagnostics, Inc.
• Product Code: DBA · Immunology
• Decision Date: Jul 14, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5250
• Device Class: Class 2

Intended Use

The N-Assay TIA Cl Inactivator Test Kit is intended to be used for the quantification of Cl Inactivator in human plasma. Cl Inactivator is measured by immunoturbidimetric assay. Measurement of Complement 1 Inhibitor aids in the diagnosis of hereditary angioneurotic edema and a rare form of angioedema associated with lymphoma.

Device Story

The N-Assay TIA C1 Inactivator Test Kit is an in vitro diagnostic reagent system used for the quantitative determination of C1 Inactivator levels in human plasma. The device utilizes an immunoturbidimetric assay principle, where the presence of C1 Inactivator in the patient sample reacts with specific antibodies to form immune complexes, resulting in turbidity measured by a clinical chemistry analyzer. The test is performed in a clinical laboratory setting by trained laboratory personnel. The output, a quantitative concentration of C1 Inactivator, is used by physicians to assist in the clinical diagnosis of hereditary angioneurotic edema and specific forms of angioedema associated with lymphoma. By providing accurate protein quantification, the device supports timely clinical decision-making and patient management.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Immunoturbidimetric assay reagent kit for use on clinical chemistry analyzers. Measures C1 Inactivator protein concentration in human plasma samples. Standard laboratory diagnostic reagent format.

Indications for Use

Indicated for the quantification of C1 Inactivator in human plasma to aid in the diagnosis of hereditary angioneurotic edema and angioedema associated with lymphoma.

Regulatory Classification

Identification

A complement C1 inhibitor (inactivator) immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the complement C1 inhibitor (a plasma protein) in serum. Complement C1 inhibitor occurs normally in plasma and blocks the action of the C1 component of complement (a group of serum proteins which destroy infectious agents). Measurement of complement C1 inhibitor aids in the diagnosis of hereditary angioneurotic edema (increased blood vessel permeability causing swelling of tissues) and a rare form of angioedema associated with lymphoma (lymph node cancer).

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service

Crestat Diagnostics, Inc.
c/o Ms. Mary Rees
Official Correspondent
374 Goodhill Road
Weston, Connecticut 06883

Food and Drug Administration
2098 Gaither Road
Rockville MD 20850

JUL 14 1997

Re: K965024/S2
Trade Name: N-Assay TIA C1 Inactivator Test Kit
Regulatory Class: II
Product Code: DBA
Dated: June 10, 1997
Received: June 13, 1997

Dear Ms. Rees:

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 current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) 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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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at [phone].

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] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html"

Sincerely yours,

Steven I. Gutman, M.D., M.B.A.
Director
Division of Clinical Laboratory Devices
Office of Device Evaluation
Center for Devices and Radiological Health

Enclosure

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Page ___ of ___

510(k) Number (if known): K965024

Device Name: N-Assay TIA Cl Inactivator Test Kit

Indications For Use:

The N-Assay TIA Cl Inactivator Test Kit is intended to be used for the quantification of Cl Inactivator in human plasma. Cl Inactivator is measured by immunoturbidimetric assay. Measurement of Complement 1 Inhibitor aids in the diagnosis of hereditary angioneurotic edema and a rare form of angioedema associated with lymphoma.


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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use ☑ (Per 21 CFR 801.109)

OK

Over-The-Counter Use ☐

(Optional Format 1-2-96)