QUALICHECK5+ MODELS S7730, S7740, S7750, S7760

K980135 · Radiometer America, Inc. · JJS · Jan 28, 1998 · Clinical Chemistry

Device Facts

• Record ID: K980135
• Device Name: QUALICHECK5+ MODELS S7730, S7740, S7750, S7760
• Applicant: Radiometer America, Inc.
• Product Code: JJS · Clinical Chemistry
• Decision Date: Jan 28, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Intended Use

Qualicheck 5+ is a liquid four ampoule quality control system for checking the precision and accuracy of Radiometer and non-Radiometer analyzers for pH/Blood Gases, Cooximetry. Electrolytes, Glucose and Lactate.

Device Story

Qualicheck 5+ is a liquid, four-level quality control system (ampoules) used to verify the precision and accuracy of clinical analyzers. It is designed for use with both Radiometer and non-Radiometer analyzers measuring pH, blood gases, co-oximetry, electrolytes, glucose, and lactate. The device serves as a reference standard to ensure analyzer performance. It is intended for use in clinical laboratory settings by trained personnel. By comparing analyzer results against the known values of the control system, healthcare providers can validate the reliability of patient test results, thereby supporting accurate clinical decision-making.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Liquid, four-level quality control system supplied in ampoules. Analyte composition includes pH, blood gases, co-oximetry, electrolytes, glucose, lactate, and chloride. Designed for use with clinical laboratory analyzers.

Indications for Use

Indicated for use as a quality control system to verify the precision and accuracy of clinical analyzers measuring pH, blood gases, co-oximetry, electrolytes, glucose, and lactate.

Regulatory Classification

Identification

A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.

Predicate Devices

• Multicheck (K961355)

Submission Summary (Full Text)

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K980135 jj

**Exhibit VII**

# RADIOMETER AMERICA INC.

MEDICAL DIVISION

811 SHARON DRIVE, WESTLAKE, OHIO

JAN 2 8 1998

510(k) SUMMARY SUBJECT:

- Donald L. Baker FROM: Director of Marketing and Regulatory Affairs Radiometer America, Inc. 810 Sharon Drive Westlake, Ohio 44145 [phone], Ext. 287 or 1-800-736-0600 Fax [phone]
- January 6, 1998 DATE:
- Trade Name Qualicheck™5 + PRODUCT: Common Name - Quality Control Classification Name - Controls for Blood Gas (assayed and unassayed)

#### PREDICATE

Multicheck™ DEVICE:

#### PRODUCT

DESCRIPTION: Qualicheck5+ is a four level quality control system consisting of part numbers S7730, S7740, S7750 and S7760. Each level consists of 30 ampoules per box.

#### INTENDED

- Qualicheck 5+ is a liquid four ampoule quality control system for checking the precision USE: and accuracy of Radiometer and non-Radiometer analyzers for pH/Blood Gases, Cooximetry. Electrolytes, Glucose and Lactate.
### TECHNOLOGICAL CHARACTERISTICS

VERSUS PREDICATE

Qualicheck5 + is technologically similar to Multicheck. DEVICE:

SUBSTANTIAL

- EQUIVALENCE: Qualicheck5+ is substantially equivalent in features and characteristics to the current Multicheck (K961355) marketed by Radiometer America Inc. The major difference is the addition of the chloride (cCL) analyte.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes forming its body and wings. The eagle is positioned within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the circumference of the circle.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JAN 2 8 1998

Donald L. Baker . Director of Marketing and Regulatory Affairs Radiometer America, Inc. 811 Sharon Drive Westlake, Ohio 44145-1598

K980135 Re : Qualicheck™ 5+ Requlatory Class: I Product Code: JJS Dated: January 6, 1997 Received: January 15, 1997

Dear Mr. Baker:

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 requlations 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 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 [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 [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,
Steven Gutman

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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MEDICAL DIVISION

### EXHIBIT IX

### 510(k) NUMBER (IF KNOWN):

4980135

DEVICE NAME:

Qualicheck™5+

## INDICATIONS FOR USE:

Qualicheck5+ is a liquid, four ampoule quality control system, for checking the precision and Qualicheck5+ is a liquid, four ampoule quality control system, to the capital of the more
accuracy of Radiometer and non-Radiometer analyzers for pH/Blood gases, Co-oximetry, Electrolytes, Glucose and Lactate.

980138

(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number. k980135

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

(Concurrence of CDRH, Office' of Device Evaluation (ODE)

t Prescription Use (Per 21 CFR 801-109)

OR

Over-The-Counter-Use (Optional Format 1-2-96)