CALIBRATION VERIFICATION ASSESSMENT (CVA)

K960557 · Streck Laboratories, Inc. · JPK · Apr 3, 1996 · Hematology

Device Facts

• Record ID: K960557
• Device Name: CALIBRATION VERIFICATION ASSESSMENT (CVA)
• Applicant: Streck Laboratories, Inc.
• Product Code: JPK · Hematology
• Decision Date: Apr 3, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 864.8625
• Device Class: Class 2

Intended Use

CVA is a calibration (linearity) assessment kit which contains white blood cell (WBC), red blood cell/hemoglobin (RBC/Hgb), and platelet (PLT) concentrations across the reportable ranges recommended by CLIA (the Clinical Laboratory Improvement Act). It is intended to allow users to satisfy CAP requirements and CLIA recommendations to verify patient reportable ranges.

Device Story

CVA; assayed hematology control; suspension of stabilized human red blood cells, human white cells, and simulated platelets (mammalian RBCs). Supplied in 2.0 mL glass vials with polypropylene screw-top caps. Used in clinical laboratories to verify instrument linearity across reportable ranges per CLIA/CAP requirements. Provides four levels of concentrations for WBC, RBC/Hgb, and PLT. Users process vials through hematology analyzers; compare results against expected values to validate system performance; ensures accuracy of patient testing.

Clinical Evidence

Bench testing only. Three studies conducted: I) lot-to-lot reproducibility; II) within-lot reproducibility and comparison with predicate and whole blood; III) long-term and open-vial stability. Results demonstrated consistent reproducibility, stability throughout product dating, and substantial equivalence to predicate.

Technological Characteristics

Stabilized human RBCs, human WBCs, and simulated platelets (mammalian RBCs). Supplied in 2.0 mL glass vials with polypropylene caps. Four-level assayed control. No electronic components, software, or connectivity.

Indications for Use

Indicated for clinical laboratory use to verify patient reportable ranges for WBC, RBC/Hgb, and PLT parameters on hematology analyzers.

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

• CBC-LINE (K942822)

Submission Summary (Full Text)

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APR - 3 1996

# 510(k) Summary of Safety and Effectiveness

510(k) Submitter:
Streck Laboratories, Inc.
14306 Industrial Road
Omaha, Nebraska 68144
K960557

Official Correspondent:
Theodore Heise, Ph.D.
Quality Assurance/Regulatory Affairs Manager
[phone]

Date Prepared:
February 8, 1996

Names of Device:
Trade Name:
Calibration Verification Assessment (CVA)
Common Name:
Assayed hematology control
Classification Name:
Hematology quality control mixture (§864.8625)

Predicate Device:
CBC-LINE (K942822)
R&D Systems, Inc.

Description: CVA is a suspension of stabilized human red blood cells, human white cells, and simulated platelets (from mammalian red blood cells) packaged as separate components. CVA is supplied in glass vials containing 2.0 mL volumes. Closures are injection molded polypropylene screw-top caps. The vials are packaged in polystyrene jars.

Intended Use: CVA is a calibration (linearity) assessment kit which contains white blood cell (WBC), red blood cell/hemoglobin (RBC/Hgb), and platelet (PLT) concentrations across the reportable ranges recommended by CLIA (the Clinical Laboratory Improvement Act). It is intended to allow users to satisfy CAP requirements and CLIA recommendations to verify patient reportable ranges.

Comparison with Predicate Device:

| Parameter | CVA | CBC-LINE |
| --- | --- | --- |
| WBC range | 0.5 - 90 × 10^{9}/L | 9.0 - 90 × 10^{9}/L |
| RBC range | 0.4 - 7.2 × 10^{12}/L | 1.6 - 7.6 × 10^{12}/L |
| PLT range | 15 - 900 × 10^{9}/L | 100 - 1100 × 10^{9}/L |
| HgB range | 1.2 - 22 g/dL | 4.5 - 23 g/dL |
| separate components | yes | yes |
| number of levels | four | six |
| assayed | yes | no |

Discussion of Tests and Test Results: Three studies of CVA were conducted: I) lot to lot reproducibility; II) within lot reproducibility and comparison with predicate product & whole blood; and III) long term and open vial stability. Study results showed CVA to be consistently reproducible, substantially equivalent to the predicate product, and stable for the entire product dating

Conclusions Drawn from Tests: CVA is a safe and effective hematology control when used as instructed in the product package insert.