CERTAIN HCT LEVEL A & LEVEL B/CVM HCT LEVELS 1,2,3, & 4

K961807 · Ciba Corning Diagnostics Corp. · GLK · Jul 26, 1996 · Hematology

Device Facts

• Record ID: K961807
• Device Name: CERTAIN HCT LEVEL A & LEVEL B/CVM HCT LEVELS 1,2,3, & 4
• Applicant: Ciba Corning Diagnostics Corp.
• Product Code: GLK · Hematology
• Decision Date: Jul 26, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.8625
• Device Class: Class 2

Intended Use

The intended use Certain® Hct is as a bi-level quality control material and CVM™ is a calibration verification material both for use with hematocrit analyzers.

Device Story

Certain® Hct and CVM™ Hct function as quality control and calibration verification materials for hematocrit analyzers; bi-level formulation for quality control; four-level formulation for calibration verification; provided in 2.5 mL ampules; used by laboratory personnel to verify analyzer performance and ensure compliance with CLIA calibration verification requirements; aqueous-based solutions containing bicarbonate and salts; provides reference values for comparison against analyzer output; assists in maintaining diagnostic accuracy of hematocrit measurements.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Assayed aqueous-based solution containing bicarbonate and other salts. Formulated as bi-level (Certain® Hct) and four-level (CVM™ Hct) materials. Supplied in 2.5 mL ampules.

Indications for Use

Indicated for use as quality control and calibration verification materials for hematocrit analyzers in clinical laboratory settings.

Regulatory Classification

Identification

A hematology quality control mixture is a device used to ascertain the accuracy and precision of manual, semiautomated, and automated determinations of cell parameters such as white cell count (WBC), red cell count (RBC), platelet count (PLT), hemoglobin, hematocrit (HCT), mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), and mean corpuscular hemoglobin concentration (MCHC).

Special Controls

*Classification.* Class II (special controls). Except when intended for use in blood components, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.

Predicate Devices

• GEM critCheck (Manufacturer: Mallinckrodt)

Submission Summary (Full Text)

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K961807
JUL 26 1996

# Summary of Safety and Effectiveness

As required by 21 CFR 807.92, the following 510(k) Summary is provided:

## 1. Submitters Information

Contact person: William J. Pignato
Director of Regulatory Affairs

Address: Chiron Diagnostics Corp.
63 North Street
Medfield, MA 02052

Phone: [phone]

Date Summary Prepared: April 25, 1996

## 2. Device Information

Proprietary Name: Certain® Hct and CVM™ Hct
Common Name: Hematocrit quality control and calibration verification materials
Classification Name: Quality Control Material (assayed & unassayed Calibration Verification Material
Classification Number: 21 CFR 862.1660

## 3. Predicate Device Information

Name: GEM critCheck
Manufacturer: Mallinckrodt
510(k) Number:

## 4. Device Description

The Chiron Certain Hct is a bi-level quality control material uniquely formulated to provide quality control values for hematocrit analyzers. There are two levels of Certain Hct each provided in 2.5 mL ampules. The product allows verification of analyzer hematocrit performance within established ranges.

Chiron Calibration Vefication Material (CVM™) is formulated to verify the calibration of hematocrit analyzers. The product contains four levels of 2.5 mL ampules and is intended to assist laboratories in compliance with the requirements of calibration verification under CLIA.

Certain® HCT 510(k) Application

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5. Statement of Intended Use

The intended use Certain® Hct is as a bi-level quality control material and CVM™ is a calibration verification material both for use with hematocrit analyzers.

6. Summary of Technological Characteristics

Certain® Hct and CVM™ Hct are assayed aqueous based bicarbonate solution and other salts.

Certain® HCT 510k) Application