Who is the manufacturer of QUALICHECK 4 METABOLITE(S3630,S3640,S3650,S3660)?

Radiometer America, Inc. filed the 510(k) submission for QUALICHECK 4 METABOLITE(S3630,S3640,S3650,S3660) (K961354).

What is the FDA product code for QUALICHECK 4 METABOLITE(S3630,S3640,S3650,S3660)?

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 QUALICHECK 4 METABOLITE(S3630,S3640,S3650,S3660)?

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

Who can help prepare an FDA 510(k) submission like QUALICHECK 4 METABOLITE(S3630,S3640,S3650,S3660)?

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.

QUALICHECK 4 METABOLITE(S3630,S3640,S3650,S3660)

Q: What are the predicate devices for QUALICHECK 4 METABOLITE(S3630,S3640,S3650,S3660)?

Qualicheck 4 Glucose (K952637).

K961354 · Radiometer America, Inc. · JJS · Jun 14, 1996 · Clinical Chemistry

Device Facts

Record ID	K961354
Device Name	QUALICHECK 4 METABOLITE(S3630,S3640,S3650,S3660)
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

Qualicheck 4 Metabolite is intended for checking the precision and accuracy of Radiometer and non-Radiometer analyzers for pH/Blood Gases, Electrolytes, Glucose and Lactate.

Device Story

Qualicheck 4 Metabolite is a four-level quality control system; supplied as 2 mL ampoules. Used by laboratory personnel to verify performance of blood gas, electrolyte, glucose, and lactate analyzers. System provides known reference values to assess analyzer precision and accuracy; enables clinical decision-making based on validated instrument performance.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Four-level quality control solution; 2 mL ampoules. Analyte composition includes pH, blood gases, electrolytes, glucose, and lactate. Designed for use with Radiometer and non-Radiometer analyzers.

Indications for Use

Indicated for use as a quality control system to verify precision and accuracy of blood gas, electrolyte, glucose, and lactate analyzers in clinical settings.

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

Qualicheck 4 Glucose (K952637)

Related Devices

K961355 — MULTICHECK · Radiometer America, Inc. · Jun 14, 1996
K980135 — QUALICHECK5+ MODELS S7730, S7740, S7750, S7760 · Radiometer America, Inc. · Jan 28, 1998
K130415 — HIGH METABOLITE QUALICHECK · Radiometer Medical Aps · Mar 26, 2013
K150226 — Hematocrit and Metabolite QUALICHECK · Radiometer Medical Aps · May 13, 2015
K130236 — RANGE + QUALICHECK LEVEL 1, RANGE + QUALICHECK LEVEL 2, RANGE + QUALICHECK LEVEL 3 · Radiometer Medical Aps · Mar 15, 2013

Submission Summary (Full Text)

{0} K961354 RADIOMETER AMERICA INC. Exhibit VII MEDICAL DIVISION 811 SHARON DRIVE, WESTLAKE, OHIO 44145-1588 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 - Qualicheck™4 Metabolite Common Name - Quality Control Classification Name - Controls for Blood Gas (assayed and unassayed) PREDICATE DEVICE: Qualicheck 4 Glucose PRODUCT DESCRIPTION: Qualicheck 4 Metabolite is a four level quality control system consisting of part numbers S3630, S3640, S3650, and S3660. Each level consists of 30 ampoules per box, 2 mL solution per ampoule. INTENDED USE: Qualicheck 4 Metabolite is intended for checking the precision and accuracy of Radiometer and non-Radiometer analyzers for pH/Blood Gases, Electrolytes, Glucose and Lactate. TECHNOLOGICAL CHARACTERISTICS VERSUS PREDICATE DEVICE: Qualicheck 4 Metabolite is technologically similar to Qualicheck 4 Glucose. SUBSTANTIAL EQUIVALENCE: Qualicheck 4 Metabolite is substantially equivalent in features and characteristics to the current Qualicheck 4 Glucose (K952637) marketed by RadiometerAmerica Inc. The only difference is the addition of the lactate analyte.