PICO MODELS 30, 50, 70

K962158 · Radiometer America, Inc. · JKA · Oct 29, 1996 · Clinical Chemistry

Device Facts

• Record ID: K962158
• Device Name: PICO MODELS 30, 50, 70
• Applicant: Radiometer America, Inc.
• Product Code: JKA · Clinical Chemistry
• Decision Date: Oct 29, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1675
• Device Class: Class 2

Intended Use

Arterial blood sampler for pH, blood gas, oximetry, electrolyte and metabolite analyses.

Device Story

PICO Arterial Blood Sampler; preheparinized, electrolyte-balanced device; collects arterial blood samples for clinical laboratory analysis of pH, blood gases, oximetry, electrolytes, and metabolites. Used in clinical settings by healthcare professionals to facilitate diagnostic testing. Device design enables sample collection and transport to analyzers; results assist clinicians in assessing patient respiratory and metabolic status.

Technological Characteristics

Preheparinized, electrolyte-balanced arterial blood sampler. Available in multiple sizes and versions. Technological design is similar to the predicate Smooth™ line.

Indications for Use

Indicated for use as an arterial blood sampler for patients requiring pH, blood gas, oximetry, electrolyte, and metabolite analysis.

Regulatory Classification

Identification

A blood specimen collection device is a device intended for medical purposes to collect and to handle blood specimens and to separate serum from nonserum (cellular) components prior to further testing. This generic type device may include blood collection tubes, vials, systems, serum separators, blood collection trays, or vacuum sample tubes.

Predicate Devices

• Smooth™ (K896514)

Reference Devices

• Qualistick
• Pulsator
• B-D

Submission Summary (Full Text)

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22

# RADIOMETER AMERICA INC.

Exhibit IX

**MEDICAL DIVISION**

K962158

811 SHARON DRIVE, WESTLAKE, OHIO 44145-1598
800-736-0600, 216-871-8900
FAX [phone]

**SUBJECT:** 510(k) SUMMARY

**OCT 29 1996**

**FROM:** Donald L. Baker
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]

**DATE:** May 16, 1996

**PRODUCT:** Trade Name -PICO
Common Name - PICO Arterial Blood Sampler
Classification Name - Kit, Sampling, Arterial Blood

**PREDICATE DEVICE:** Qualistick, Pulsator, B-D, QS90 Smooth™

**PRODUCT DESCRIPTION:** Preheparinized, electrolyte balanced, arterial blood sampler for pH, blood gas, oximetry, electrolyte and metabolite analyses. Available in multiple sizes and product versions.

**INTENDED USE:** Arterial blood sampler for pH, blood gas, oximetry, electrolyte and metabolite analyses.

**TECHNOLOGICAL CHARACTERISTICS VERSUS PREDICATE DEVICE:** PICO product line is technologically similar to the Smooth™ product line.

**SUBSTANTIAL EQUIVALENCE:** The PICO product line is substantially equivalent in features, intended use, and characteristics to the current Smooth™ product line (K896514) marketed by Radiometer America Inc. The significant difference from Smooth™ to the new PICO design is the addition of metabolite and oximetry to the product labeling.