2487 DUAL WAVELENGTH ABSORBANCE DETECTOR

K973074 · Waters Corporation · KZR · Oct 6, 1997 · Clinical Chemistry

Device Facts

• Record ID: K973074
• Device Name: 2487 DUAL WAVELENGTH ABSORBANCE DETECTOR
• Applicant: Waters Corporation
• Product Code: KZR · Clinical Chemistry
• Decision Date: Oct 6, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.2260
• Device Class: Class 1

Indications for Use

The Waters 2487 Dual Wavelength Detector is designed for the routine Quality Assurance/Quality Control laboratory as well as possessing features which would meet methods development and R&D requirements. Waters believes this detector will be utilized in both large and small facilities where high reliability, ease of training, start-up and operation, and design efficiency are important. These facilities may include Universities, industrial and pharmaceutical facilities, manufacturing facilities, analytical laboratories and hospitals.

Device Story

Waters 2487 Dual Wavelength Detector is an analytical instrument for laboratory use; functions as a detector for chromatography systems. Input: chemical samples processed via chromatography; device measures absorbance at dual wavelengths. Operation: detects light absorbance to quantify sample components; used by laboratory technicians/scientists in analytical, pharmaceutical, or hospital labs. Output: absorbance data used for quality control, assurance, and methods development. Device facilitates chemical analysis and sample characterization; supports research and manufacturing workflows.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Dual wavelength absorbance detector; designed for chromatography applications. Operates as a laboratory analytical instrument. No specific materials, software architecture, or connectivity standards provided in the document.

Indications for Use

Indicated for use in laboratory settings including universities, industrial/pharmaceutical facilities, manufacturing, analytical labs, and hospitals for quality assurance, quality control, and methods development. Not intended exclusively for clinical use.

Regulatory Classification

Identification

A high pressure liquid chromatography system for clinical use is a device intended to separate one or more drugs or compounds from a solution by processing the mixture of compounds (solutes) through a column packed with materials of uniform size (stationary phase) under the influence of a high pressure liquid (mobile phase). Separation of the solutes occurs either by absorption, sieving, partition, or selective affinity.

Submission Summary (Full Text)

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Food and Drug Administration 2098 Gaither Road Rockville MD 20850

OCT - 6 1997

Virqinia L. Corbin . Director, Regulatory Affairs Water Corporation 34 Maple Street Milford, Massachusetts 01757-3696

Re : K973074 Waters® 2487 Tunable Dual Wavelenqth Absorbance Dectector Regulatory Class: I Product Code: KZR Dated: August 13, 1997 Received: August 18, 1997

Dear Ms. Corbin:

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 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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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 caesgoriers 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 Also, please note the Office of Compliance at [phone]. 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 "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,
Steven Butman

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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## ATTACHMENT R

510(k) number (if known): .

Device Name: Waters® 2487 Dual Wavelength Detector

Indications For Use:

The Waters 2487 Dual Wavelength Detector is designed for the routine Quality Assurance/Quality Control laboratory as well as possessing features which would meet methods development and R&D requirements. Waters believes this detector will be utilized in both large and small facilities where high reliability, ease of training, start-up and operation, and design efficiency are important. These facilities may include Universities, industrial and pharmaceutical facilities, manufacturing facilities, analytical laboratories and hospitals.

## The product is not intended exclusively for clinical use.

In using this product, the operator must follow generally accepted procedures for quality control and methods development.

## (PLEASE DO NOI 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) Num. K9935074