AG CHEMISTRY ANALYZER SYSTEM

K972409 · Landmark Scientific, Inc. · JJG · Aug 28, 1997 · Clinical Chemistry

Device Facts

• Record ID: K972409
• Device Name: AG CHEMISTRY ANALYZER SYSTEM
• Applicant: Landmark Scientific, Inc.
• Product Code: JJG · Clinical Chemistry
• Decision Date: Aug 28, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.2140
• Device Class: Class 1

Intended Use

The AG" Chemistry Analyzer is indicated for in vitro diagnostic use for the quantitative determination of body fluid constituents using automated spectrophotometric methods.

Device Story

AG" Automated Chemistry Analyzer is a compact clinical chemistry analyzer for laboratory use. It processes body fluid samples using a self-contained cuvette rotor design; reactions occur within the rotor via centrifugal force, eliminating the need for transfer to separate reading chambers. The system features an integrated pipettor/dilutor with a rack and pinion drive (3000-step resolution). It is controlled by a personal computer with a monitor, storage, and printer. The device provides quantitative spectrophotometric analysis of body fluid constituents. Healthcare providers use the output to determine clinical chemistry values, aiding in diagnostic decision-making. The system offers a smaller footprint and reduced weight compared to previous models, facilitating use in clinical laboratory environments.

Clinical Evidence

Bench testing performed, including electrical safety, electromagnetic compatibility, precision, and accuracy assessments. Comparative performance testing was conducted using clinical samples to evaluate the AG" system against the predicate device. No specific clinical trial data or statistical metrics (e.g., sensitivity/specificity) were provided in the summary.

Technological Characteristics

Centrifugal chemistry analyzer; self-contained 40-cuvette rotor; rack and pinion pump drive (3000-step resolution); integrated pipettor/dilutor; spectrophotometric sensing; PC-controlled with monitor, floppy/hard drive, and printer. Hardware updated from predicate; cosmetic modifications.

Indications for Use

Indicated for in vitro diagnostic quantitative determination of body fluid constituents in clinical laboratory settings.

Regulatory Classification

Identification

A centrifugal chemistry analyzer for clinical use is an automatic device intended to centrifugally mix a sample and a reagent and spectrophotometrically measure concentrations of the sample constituents. This device is intended for use in conjunction with certain materials to measure a variety of analytes.

Predicate Devices

• AutoMed Centrifugal Analyzer with Automated Rotor Loader (K781900 and K853453)

Reference Devices

• ASCA Automated Spin Chemistry Analyzer

Submission Summary (Full Text)

{0}------------------------------------------------

K 712469

AUG 2 8 1997

## 510(k) Summary

Landmark Scientific Inc.

| | Common/Classification Name: Centrifugal Chemistry Analyzer for Clinical<br>Use<br>21 CFR 862.2140, Class I |
|-----------|------------------------------------------------------------------------------------------------------------|
| Sponsor: | Landmark Scientific Inc.<br>110-B Creek Ridge Road<br>Greensboro, NC 27406 |
| | Tel.: [phone]<br>FAX: [phone] |
| Contact: | Steve Kincaid |
| Prepared: | June 17, 1997 |

#### A. LEGALLY MARKETED PREDICATE DEVICES

The AG" Automated Chemistry Analyzer System is substantially equivalent to its predicate device currently marketed by Landmark Scientific, the AutoMed Centrifugal Analyzer with Automated Rotor Loader (K781900 and K853453).

#### B. DEVICE DESCRIPTION

The AG" Automated Chemistry Analyzer is the latest in a series of automated blood chemistry analyzers for the clinical chemistry laboratory that have become more and more compact as the miniaturization of the technology of the various components has proceeded. The AG" weighs only 37% as much as the currently marketed device, the ASCA Automated Spin Chemistry Analyzer, and has a "footprint" only about one-third as large. The AG" is controlled with a personal computer with a good color monitor, floppy disk drive, hard drive, and printer.

The cuvette rotor has a unique self-contained design. Forty cuvettes make up a single cuvette rotor. Each cuvette is made up of a sample shelf and reagent well. The design allows reactions to be completed in the rotor rather than having to be transferred upon mixing, by centrifugal force, to a separate cuvette or reading chamber. The pump uses a rack and pinion drive with a resolution of 3000 steps. The integrated pipettor/dilutor boasts an accuracy of & 1.0% at full stroke and a

# 000031

{1}------------------------------------------------

precision of & 0.05% CV within-run at full stroke. This provides excellent accuracy and precision over a wide range of volumes and speeds.

#### INTENDED USE C.

The AG" Chemistry Analyzer is indicated for in vitro diagnostic use for the quantitative determination of body fluid constituents using automated spectrophotometric methods.

#### TECHNOLOGICAL CHARACTERISTICS D.

The AG" System has the same technological characteristics as the predicate device. The AG" is simply a modification with updated hardware and cosmetic changes from the predicate device.

#### TESTING E.

Landmark Scientific carried out testing to address the following issues:

- (1) electrical safety;
- (2) electromagnetic compatibility;
- (3) precision;
- (4) accuracy of results for standard samples; and
- comparison of performance of the AG" and predicate device on (5) clinical samples.

The results from these tests supported the safety and effectiveness of the AG" System and demonstrated that it is substantially equivalent to the predicate device.

#### CONCLUSIONS F.

The AG" device has the same intended use as the predicate device. Landmark Scientific Inc. has demonstrated through its performance tests on the AG" System and its comparison of the AG" characteristics with those of the predicate device that the AG" System is substantially equivalent to the predicate device.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image contains the text "Public Health Service". The text is in a simple, sans-serif font and is horizontally aligned. The text is likely part of a document or sign, indicating an affiliation with a public health organization.

Image /page/2/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of a human figure in profile, with three overlapping faces suggesting a sense of community or interconnectedness. The figure is positioned within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged around the upper portion of the circle.

AUG 28 1997

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

T. Whit Athey, Ph.D. Senior Consultant Landmark Scientific, Inc. 110-B Creek Ridge Road Greensboro, North Carolina 27406

Re : K972409 Trade Name: AGI Chemistry Analyzer System Regulatory Class: I Product Code: JJG Dated: June 25, 1997 Received: June 26, 1997

Dear Dr. Athey:

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 requlation (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 requlatory 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 obliqation you miqht have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal Laws or Regulations.

{3}------------------------------------------------

Page 2

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 [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 requlation (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 at [phone] 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 Radioloqical Health

Enclosure

{4}------------------------------------------------

### STATEMENT OF INDICATIONS FOR USE

510(k) Number (if known):
K092409

Device Name: AG" Clinical Chemistry Analyzer_

Indications For Use:

The AG" Chemistry Analyzer is indicated for in vitro diagnostic use for the quanitiative determination of body fluid constituents using automated spectrophotometric methods.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Clinical 1. Laboratory Devices
510(k) Number K972409

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter Use