(209 days)
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No
The summary describes a laboratory test kit using an immunoturbidimetric assay, with no mention of AI or ML in the intended use, device description, or any other section.
No
The device is a diagnostic test kit used to quantify Cl Inactivator in human plasma, which aids in the diagnosis of specific conditions. It does not provide therapeutic treatment.
Yes
The device is described as aiding in the "diagnosis of hereditary angioneurotic edema and a rare form of angioedema associated with lymphoma." This directly indicates its use in diagnosing medical conditions.
No
The device is a test kit intended for quantifying a substance in human plasma using an immunoturbidimetric assay, which implies the use of physical reagents and laboratory equipment, not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is used for the "quantification of Cl Inactivator in human plasma." This involves testing a sample taken from the human body (plasma) outside of the body (in vitro).
- Purpose: The measurement of Cl Inhibitor "aids in the diagnosis of hereditary angioneurotic edema and a rare form of angioedema associated with lymphoma." This diagnostic purpose is a key characteristic of IVDs.
- Method: The method used is an "immunoturbidimetric assay," which is a common laboratory technique performed in vitro.
Therefore, based on the intended use, purpose, and method described, the N-Assay TIA C1 Inactivator Test Kit fits the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The N-Assay TIA C1 Inactivator Test Kit is intended to be used for the quantification of C1 Inactivator in human plasma. C1 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.
Product codes
DBA
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 866.5250 Complement C
1 inhibitor (inactivator) immunological test system.(a)
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).(b)
Classification. Class II (performance standards).
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, which is a symbol often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus. The logo is simple and monochromatic, with a focus on the symbol and the name of the department.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Crestat Diagnostics, Inc. c/o Ms. Mary Rees Official Correspondent 374 Goodhill Road Weston, Connecticut 06883
JUL 1 4 1997
K965024/S2 Re : 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 A substantially equivalent determination assumes compliance to 895. 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 (770)488-7655.
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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. 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 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html"
Sincerely yours,
Steven Putman
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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510(k) Number (il known): K965024
Ocvice Name: N-Assay TIA Cl Inactivator Test Kit
Indications I-or Use:
The N-Assay TIA C1 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 I Inhibitor aids in the diagnosis of hereditary angioneurotic edema and a rare form of angioedema associated with lymphoma.
Peter E. Makim
(Division Sign Off)
Division Sign-Off) Division of Clinical Laboratory Devices 510(k) Number
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF
EEDED) NEEDED)
Concurrence of CORIA, Office of Device Evaluation (ODE) irrescription lise りは 9000 The Counter Use _________________________________________________________________________________________________________________________________________________________ Por 21 Chil Boi : 091
(Optional Formal 1-2-96)