AUDIT MICROCONTROLS MICROFD BNP CONTROL

K032122 · Aalto Scientific, Ltd. · JJY · Sep 9, 2003 · Clinical Chemistry

Device Facts

• Record ID: K032122
• Device Name: AUDIT MICROCONTROLS MICROFD BNP CONTROL
• Applicant: Aalto Scientific, Ltd.
• Product Code: JJY · Clinical Chemistry
• Decision Date: Sep 9, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Intended Use

Audit™ MicroFD™ BNP Control is an assayed bi-level reference control consisting of human plasma based solutions. It is intended to simulate human patient plasma samples for the purpose of monitoring the precision and to detect systematic analytical deviations of laboratory testing procedures for both BNP-32 and NT-proBNP assays.

Device Story

Audit™ MicroFD™ BNP Control; human plasma-based, buffered, bacteriostatic, and fungistatic matrix; lyophilized form. Used in clinical laboratories to monitor precision and detect systematic analytical deviations in BNP-32 and NT-proBNP assays. Simulates human patient plasma samples. Provides healthcare providers with quality control data to verify assay performance and ensure accuracy of patient test results.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Human plasma-based solution; bi-level reference control; assayed for BNP-32 and NT-proBNP analytes.

Indications for Use

Indicated for use as an assayed bi-level reference control to monitor precision and detect systematic analytical deviations in laboratory testing procedures for BNP-32 and NT-proBNP assays.

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.

Submission Summary (Full Text)

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510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION
DECISION SUMMARY
DEVICE ONLY TEMPLATE

A. 510(k) Number:
K032122

B. Analyte:
Quality control material for BNP and NT proBNP

C. Type of Test:
N/A Controls only

D. Applicant:
Aalto Scientific Ltd.

E. Proprietary and Established Names:
Audit™ MicroControl MicroFD™ BNP Control

F. Regulatory Information:
1. Regulation section:
21 CFR 862.1660, Multi-Analyte Controls, All Kinds (assayed and unassayed)
2. Classification:
Class I
3. Product Code:
JJY
4. Panel:
75

G. Intended Use:
1. Indication(s) for use:
Audit™ MicroFD™ BNP Control is an assayed bi-level reference control consisting of human plasma based solutions. It is intended to simulate human patient plasma samples for the purpose of monitoring the precision and to detect systematic analytical deviations of laboratory testing procedures for both BNP-32 and NT-proBNP assays.
2. Special condition for use statement(s):
NA
3. Special instrument Requirements:
NA

H. Device Description:
Audit™ MicroFD™ BNP Control is an in vitro diagnostic control composed of a buffered bacteriostatic and fungistatic human plasma matrix.

I. Substantial Equivalence Information:
1. Predicate device name(s):
Biosite Triage® BNP Control; Roche Diagnostics PreciControl proBNP
2. Predicate K number(s):
K000231; K022516

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3. Comparison with predicate:

| Similarities | | | |
| --- | --- | --- | --- |
| Item | Audit BNP Control | Biosite BNP Control | PreciControl BNP |
| No. of Levels | 2 | 2 | 2 |
| Matrix | Human source | Human source | Human source |
| Differences | | | |
| Item | Audit BNP Control | Biosite BNP Control | PreciControl BNP |
| Preparation | lyophilized | frozen | lyophilized |
| Analytes | BNP, NT ProBNP | BNP | NT ProBNP |

J. Standard/Guidance Document Referenced (if applicable): None referenced

K. Test Principle: NA

L. Performance Characteristics (if/when applicable):

1. Analytical performance:
a. Precision/Reproducibility: NA
b. Linearity/assay reportable range: NA
c. Traceability (controls, calibrators, or method): Evaluators at pre-selected laboratories follow value assignment protocol.
d. Detection limit: NA
e. Analytical specificity: NA
f. Assay cut-off: NA

2. Comparison studies:
a. Method comparison with predicate device: NA
b. Matrix comparison: NA

3. Clinical studies:
a. Clinical sensitivity: NA
b. Clinical specificity: NA
c. Other clinical supportive data (when a and b are not applicable):

4. Clinical cut-off: NA

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5. Expected values/Reference range: NA

**M. Conclusion:**

Based upon the information provided for the file, I recommend that the Audit™ MicroControl MicroFD™ BNP Controls are substantially equivalent to the predicate devices.