(46 days)
Not Found
Not Found
No
The summary describes a liquid reagent for a quantitative diagnostic test and contains no mention of AI or ML.
No.
The device is for in vitro diagnostic use, specifically for quantitative determination of cholinesterase in serum, which is an analytical laboratory test, not a therapeutic intervention on a patient.
Yes
The device is described as being for "quantitative determination of cholinesterase in serum," which is a measurement used for diagnostic purposes. Additionally, the phrase "For In Vitro diagnostic use only" explicitly states its diagnostic function.
No
The device description clearly states "Sentinel Cholinesterase Liquid Model Number 17.019A & 17.606", indicating a liquid reagent, which is a physical component, not software. The intended use also specifies "In Vitro diagnostic use only," further suggesting a laboratory test involving physical materials.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" explicitly states: "For quantitative determination of cholinesterase in serum. For In Vitro diagnostic use only."
This statement clearly indicates that the device is intended to be used outside of the body (in vitro) to diagnose or aid in the diagnosis of a condition by analyzing a sample (serum).
N/A
Intended Use / Indications for Use
For quantitative determination of cholinesterase in serum. For In Vitro diagnostic use only.
Product codes
DIH, DLI
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
serum
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 884.1690 Hysteroscope and accessories.
(a)
Identification. A hysteroscope is a device used to permit direct viewing of the cervical canal and the uterine cavity by a telescopic system introduced into the uterus through the cervix. It is used to perform diagnostic and surgical procedures other than sterilization. This generic type of device may include obturators and sheaths, instruments used through an operating channel, scope preheaters, light sources and cables, and component parts.(b)
Classification. (1) Class II (performance standards).(2) Class I for hysteroscope accessories that are not part of a specialized instrument or device delivery system; do not have adapters, connectors, channels, or do not have portals for electrosurgical, laser, or other power sources. Such hysteroscope accessory instruments include: lens cleaning brush, cannula (without trocar or valves), clamp/hemostat/grasper, curette, instrument guide, forceps, dissector, mechanical (noninflatable), and scissors. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 884.9.
0
Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with its wings spread, facing to the right. The eagle is surrounded by a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in capital letters. The text is arranged around the circumference of the circle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
C 1008 JUL
Brenda Y. Kan · Equal Diagnostics 115 Summit Drive 19341 Exton, Pennsylvania
Re : K981800 Sentinel Cholinesterase Liquid Model Number 17.019A & 17.606 Regulatory Class: I Product Code: DIH, DLI May 20, 1998 Dated: May 21, 1998 Received:
Dear Ms. Kan:
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, Druq, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act 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 Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, 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 In addition, FDA may publish further announcements action. 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 requlations.
1
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 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 (301) 443-6597 or at
its internet address "dsmo@fdadr.cdrh.fda.qov".
Sincerely yours,
Steven Autman
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
Page 2
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Page 1 of _1 __
510(k) Number (if known):
Device Name: Sentinel Cholinesterase Liquid
. .
. ( (
Indications For Use : For quantitative determination of cholinesterase in serum. For In Vitro diagnostic use only.
(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) | |
|---|---|
| -------------------------------------------------- | -- |
(Division Sign-Off)
Division of Clinical Laboratory Devices
| 510(k) Number | K981808 |
|---|---|
| --------------- | --------- |