(258 days)
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No
The summary describes a laboratory test kit based on an immunoturbidimetric assay, which is a standard biochemical method. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices.
No
This device is a diagnostic test kit for measuring haptoglobin levels, which aids in the diagnosis of certain diseases, rather than providing therapy.
Yes
Explanation: The "Intended Use" section explicitly states that "Measurement of haptoglobin may aid in the diagnosis of hemolytic diseases related to the formation of hemoglobin-haptoglobin complexes and certain kidney diseases." This indicates its use in the diagnostic process.
No
The summary describes a "Test Kit" for a laboratory assay, which inherently involves physical reagents and potentially instrumentation, not just 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 "quantitation of haptoglobin in human serum by immunoturbidimetric assay." This involves testing a sample taken from the human body (serum) in vitro (outside the body) to provide information about a physiological state (haptoglobin levels).
- Purpose: The purpose is to "aid in the diagnosis of hemolytic diseases... and certain kidney diseases." This directly aligns with the definition of an IVD, which is used to examine specimens derived from the human body to provide information for diagnostic purposes.
The information provided strongly indicates that this device fits the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The N-Assay TIA Haptoglobin Test Kit is intended to be used for the quantitation of haptoglobin in human serum by immunoturbidimetric assay. Measurement of haptoglobin may aid in the diagnosis of hemolytic diseases related to the formation of hemoglobin-haptoglobin complexes and certain kidney diseases.
Product codes
DAD
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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc)
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§ 866.5460 Haptoglobin immunological test system.
(a)
Identification. A haptoglobin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the haptoglobin (a protein that binds hemoglobin, the oxygen-carrying pigment in red blood cells) in serum. Measurement of haptoglobin may aid in the diagnosis of hemolytic diseases (diseases in which the red blood cells rupture and release hemoglobin) related to the formation of hemoglobin-haptoglobin complexes and certain kidney diseases.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 866.9.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized image of an eagle with its wings spread, with the profile of a human face incorporated into the body of the eagle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the eagle image.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Crestat Diagnostics, Inc. c/o Ms. Mary Rees Official Correspondent 374 Goodhill Ròad Weston, Connecticut 06883
JUL | 4 1997
Re: - K964301/S3 Trade Name: N-Assay TIA Multi V-NL Requlatory Class: II Product Code: DAD 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 (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 regulation (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 requlation 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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K964301 510(k) Number (il known):
Ocvice Nomc: N-Assay TIA Haptoglobin Test Kit
Indications I·or Usc:
The N-Assay TIA Haptoglobin Test Kit is intended to be used for the quantitation of haptoglobin in human serum by immunoturbidimetric assay. Measurement of haptoglobin may aid in the diagnosis of hemolytic diseases related to the formation of hemoglobin-haptoglobin complexes and certain kidney diseases.
Peter E. Mahlum
(Division Sign-Off) Division of Clinical Laboratory Devices 510(k) Number _
IPLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)