SENTINEL CHOLINESTERASE LIQUID MODEL NUMBER 17.019A & 17.606

K981800 · Equal Diagnostics, Inc. · HIH · Jul 6, 1998 · Obstetrics/Gynecology

Device Facts

• Record ID: K981800
• Device Name: SENTINEL CHOLINESTERASE LIQUID MODEL NUMBER 17.019A & 17.606
• Applicant: Equal Diagnostics, Inc.
• Product Code: HIH · Obstetrics/Gynecology
• Decision Date: Jul 6, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.1690
• Device Class: Class 2

Intended Use

For quantitative determination of cholinesterase in serum. For In Vitro diagnostic use only.

Device Story

Sentinel Cholinesterase Liquid is an in vitro diagnostic reagent used for the quantitative measurement of cholinesterase levels in human serum. The device functions as a chemical assay; it is intended for use in clinical laboratory settings by trained personnel. The assay provides numerical results that assist healthcare providers in assessing cholinesterase activity, which is clinically relevant for monitoring exposure to organophosphate pesticides or identifying genetic variants of the enzyme. The device is intended for prescription use only.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Liquid reagent for in vitro diagnostic use. Chemical assay principle for quantitative determination of cholinesterase in serum. No software or electronic components.

Indications for Use

Indicated for the quantitative determination of cholinesterase in human serum for in vitro diagnostic use. Intended for prescription use by clinical laboratory professionals.

Regulatory Classification

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.

Submission Summary (Full Text)

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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.

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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 [phone] or at

its internet address "[e-mail]".

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

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510(k) Number (if known):

Device Name: Sentinel Cholinesterase Liquid

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Indications For Use : For quantitative determination of cholinesterase in serum. For In Vitro diagnostic use only.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use<br>(Per 21 CFR 801.109) | <div> <span style="font-size: 2em;">✓</span> </div> |
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OR

| Over-The-Counter Use<br>(Optional Format 1-2-96) | |
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(Division Sign-Off)

Division of Clinical Laboratory Devices

| 510(k) Number | K981808 |
|---------------|---------|
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