Who is the manufacturer of MULTICHECK?

Radiometer America, Inc. filed the 510(k) submission for MULTICHECK (K961355).

What is the FDA product code for MULTICHECK?

JJS. It is classified under 21 CFR 862.1660 as a Class 1 device in the Clinical Chemistry panel.

What is the regulatory pathway for MULTICHECK?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like MULTICHECK?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

MULTICHECK

K961355 · Radiometer America, Inc. · JJS · Jun 14, 1996 · Clinical Chemistry

Device Facts

Record ID	K961355
Device Name	MULTICHECK
Applicant	Radiometer America, Inc.
Product Code	JJS · Clinical Chemistry
Decision Date	Jun 14, 1996
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 862.1660
Device Class	Class 1

Intended Use

Multicheck™ with metabolite is intended for checking the precision and accuracy of Radiometer and non-Radiometer analyzers for pH/Blood Gases, Oximetry, Electrolytes, and Glucose and Lactate.

Device Story

Multicheck™ with metabolite; four-level quality control system; 30 ampoules per box, 2 mL solution per ampoule. Used in clinical laboratory settings to verify performance of blood gas, oximetry, electrolyte, glucose, and lactate analyzers. Healthcare professionals use control results to assess analyzer precision and accuracy, ensuring reliable patient diagnostic data.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Four-level aqueous quality control solution; contains pH, blood gas, oximetry, electrolyte, glucose, and lactate analytes. Packaged in 2 mL ampoules.

Indications for Use

Indicated for quality control testing of blood gas, oximetry, electrolyte, glucose, and lactate analyzers to verify precision and accuracy.

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™ (K952725)

Related Devices

K961354 — QUALICHECK 4 METABOLITE(S3630,S3640,S3650,S3660) · Radiometer America, Inc. · Jun 14, 1996
K130415 — HIGH METABOLITE QUALICHECK · Radiometer Medical Aps · Mar 26, 2013
K150226 — Hematocrit and Metabolite QUALICHECK · Radiometer Medical Aps · May 13, 2015
K980135 — QUALICHECK5+ MODELS S7730, S7740, S7750, S7760 · Radiometer America, Inc. · Jan 28, 1998
K130236 — RANGE + QUALICHECK LEVEL 1, RANGE + QUALICHECK LEVEL 2, RANGE + QUALICHECK LEVEL 3 · Radiometer Medical Aps · Mar 15, 2013

Submission Summary (Full Text)

{0} RADIOMETER AMERICA INC. K961355 Exhibit VII MEDICAL DIVISION 811 SHARON DRIVE, WESTLAKE, OHIO 44145-1598 800-736-0600, 216-871-8900 FAX 216-892-8117 JUN 14 1996 SUBJECT: 510(k) SUMMARY FROM: Donald L. Baker Director of Marketing and Regulatory Affairs Radiometer America, Inc. 810 Sharon Drive Westlake, Ohio 44145 (216)871-8900, Ext287 or 1-800-736-0600 Fax (216)871-8117 DATE: April 1, 1996 PRODUCT: Trade Name - Multicheck™ Common Name - Quality Control Classification Name - Controls for Blood Gas (assayed and unassayed) PREDICATE DEVICE: Multicheck™ PRODUCT DESCRIPTION: Multicheck™ with metabolite is a four level quality control system consisting of part numbers S5530, S5540, S5550, and S5560. Each level consists of 30 ampoules per box, 2 mL solution per ampoule. INTENDED USE: Multicheck™ with metabolite is intended for checking the precision and accuracy of Radiometer and non-Radiometer analyzers for pH/Blood Gases, Oximetry, Electrolytes, and Glucose and Lactate. TECHNOLOGICAL CHARACTERISTICS VERSUS PREDICATE DEVICE: Multicheck™ with metabolite is technologically similar to Multicheck™ with glucose. SUBSTANTIAL EQUIVALENCE: Multicheck™ with metabolite is substantially equivalent in features and characteristics to the current Multicheck (K952725) marketed by RadiometerAmerica Inc. The only difference is the addition of the lactate analyte.