N-ASSAY TIA C4 TEST KIT

K964297 · Crestat Diagnostics, Inc. · DBI · Jul 14, 1997 · Immunology

Device Facts

• Record ID: K964297
• Device Name: N-ASSAY TIA C4 TEST KIT
• Applicant: Crestat Diagnostics, Inc.
• Product Code: DBI · Immunology
• Decision Date: Jul 14, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 866.5240
• Device Class: Class 2

Intended Use

The N-Assay TIA Test Kit is intended to be used for the quantitative determination of human C4 (4th complement component) in human serum by immunoturbidimetric assay. C4 aids in the diagnosing of immunological disorders, especially those associated with complement deficiency disorders.

Device Story

N-Assay TIA C4 Test Kit is an in vitro diagnostic reagent system for quantitative measurement of C4 in human serum. Principle of operation: immunoturbidimetric assay; antigen-antibody reaction between C4 in patient sample and anti-C4 antibodies causes turbidity proportional to C4 concentration. Used in clinical laboratory settings by trained laboratory personnel. Output is a quantitative concentration value of C4. Healthcare providers use this result to assess immunological status and diagnose complement deficiency disorders. Benefits include rapid, automated quantification of C4 levels to support clinical decision-making regarding immune system health.

Clinical Evidence

No clinical data provided in the document; bench testing only.

Technological Characteristics

Immunoturbidimetric assay for C4 quantification. Reagent-based diagnostic test. Designed for use with automated clinical chemistry analyzers. No specific materials, energy sources, or software algorithms described.

Indications for Use

Indicated for the quantitative determination of human C4 in human serum to aid in the diagnosis of immunological disorders, particularly those associated with complement deficiency.

Regulatory Classification

Identification

A complement components immunological test system is a device that consists of the reagents used to measure by immunochemical techniques complement components C1q , C1r , C1s , C2 , C3 , C4 , C5 , C6 , C7 , C8 , and C9 , in serum, other body fluids, and tissues. Complement is a group of serum proteins which destroy infectious agents. Measurements of these proteins aids in the diagnosis of immunologic disorders, especially those associated with deficiencies of complement components.

Submission Summary (Full Text)

{0}

DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service

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

Re: K964297/S3
Trade Name: N-Assay TIA C4 Test Kit
Regulatory Class: II
Product Code: DBI
Dated: May 3, 1997
Received: May 12, 1997

Food and Drug Administration
2098 Gaither Road
Rockville MD 20850

JUL 14 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.

{1}

Page 2

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

{2}

Page ___ of ___

510(k) Number (if known): K964297

Device Name: N-Assay TIA C4 Test Kit

Indications For Use:

The N-Assay TIA Test Kit is intended to be used for the quantitative determination of human C4 (4th complement component) in human serum by immunoturbidimetric assay. C4 aids in the diagnosing of immunological disorders, especially those associated with complement deficiency disorders.


(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)

OR

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