NOVA-ONE LIPID CONTROL (SPECIAL LOW INTERFERENCE LIQUID LIPID CONTROL)

K040352 · Bioresource Technology, Inc. · JJY · Apr 2, 2004 · Clinical Chemistry

Device Facts

• Record ID: K040352
• Device Name: NOVA-ONE LIPID CONTROL (SPECIAL LOW INTERFERENCE LIQUID LIPID CONTROL)
• Applicant: Bioresource Technology, Inc.
• Product Code: JJY · Clinical Chemistry
• Decision Date: Apr 2, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1660
• Device Class: Class 1

Intended Use

NOVA-One Control is intended for use in the laboratory to monitor the accuracy and precision of the listed constituents. The routine use of quality control materials is an integral part of evaluating the accuracy and precision of laboratory analysis.

Device Story

NOVA-ONE Lipid Control is a human-derived liquid quality control material; used in clinical laboratories to verify accuracy and precision of lipid analysis assays; functions as a reference material to monitor instrument performance and analytical stability; provides known values for constituents to allow comparison against laboratory results; assists healthcare providers in validating diagnostic test reliability; ensures consistent clinical decision-making by confirming assay performance.

Clinical Evidence

No clinical data. Bench testing only. Stability validated via accelerated temperature studies (acceptance criterion ±15% of zero time value). Value assignment performed by assaying samples over three days with acceptance criteria of SD ≤15%.

Technological Characteristics

Liquid control material; human serum base with purified human proteins/chemicals. Two-level (Normal/Abnormal) form factor. Stability: 2 years at -20°C; 90 days unopened at 2-8°C; 30 days opened at 2-8°C. No electronic components or software.

Indications for Use

Indicated for laboratory use to monitor accuracy and precision of lipid constituent analysis. No specific patient population or contraindications described.

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)

{0}

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

A. 510(k) Number:
k040352

B. Analyte:
Total cholesterol, HDL cholesterol, LDL cholesterol, Apolipoprotein A-1, Apolipoprotein B, triglycerides, C-reactive protein

C. Type of Test:
Quality control materials

D. Applicant:
Bioresource Technology Inc.

E. Proprietary and Established Names:
NOVA-ONE Lipid Control (Special Low Interference Liquid Lipid Control)

F. Regulatory Information:
1. Regulation section:
21 CFR §862.1660 Quality control material (assayed and unassayed)
2. Classification:
Class I
3. Product Code:
JJY
4. Panel:
75 – Clinical Chemistry

G. Intended Use:
1. Indication(s) for use:
“NOVA-One Control is intended for use in the laboratory to monitor the accuracy and precision of the listed constituents. The routine use of quality control materials is an integral part of evaluating the accuracy and precision of laboratory analysis.”
2. Special condition for use statement(s):
None described.
3. Special instrument Requirements:
This control is intended for use on the Cobras Mira, Abaxis Piccolo, Olympus AU5200/5400 and the Beckman Coulter Immage; not all components are tested by all instrument systems (see Expected Values below for table).

{1}

Page 2 of 4

H. Device Description:
The device consists of two vials of liquid materials, Level 1(Normal) and Level 2 (Abnormal), prepared from human serum to which purified human proteins and chemicals have been added.

I. Substantial Equivalence Information:
1. Predicate device name(s):
Medical Analysis Systems Liquid Assayed Lipid Control
2. Predicate K number(s):
k013734
3. Comparison with predicate:
Both products are two-level ready to use liquid controls. Both are based on human serum with various analytes added to adjust concentrations. They have an identical intended use, similar stability, and are used on identical or similar instrument systems. The nominal values of the individual analytes in each product are slightly different.

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

K. Test Principle:
N/A

L. Performance Characteristics (if/when applicable):
1. Analytical performance:
a. Precision/Reproducibility:
N/A
b. Linearity/assay reportable range:
N/A
c. Traceability (controls, calibrators, or method):
Value Assignment: On three days, three representative samples of the lot are assayed once for a specific component on its applicable instrument(s). The data is evaluated for gross outliers and a mean and standard deviation are calculated. The acceptance criterion for each method/analyte is a standard deviation of ≤15%.
Traceability: The instrument is calibrated with appropriate calibrators, and then a control from another manufacturer is run with the Bioresource control being tested. The sponsor did not provide traceability of the components to any international or internal reference standards.
Stability: The sponsor states that the product is stable for 2 years at -20°C, for 90 days at 2-8°C when unopened, and for 30 days at 2-8°C after opening. These claims are based on accelerated temperature

{2}

Page 3 of 4

studies, where the acceptance criterion was $\pm 15\%$ of the zero time value.

d. Detection limit:
N/A

e. Analytical specificity:
N/A

f. Assay cut-off:
N/A

2. Comparison studies:
a. Method comparison with predicate device:
N/A
b. Matrix comparison:
N/A

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

4. Clinical cut-off:
N/A

5. Expected values/Reference range:

Representative Assigned Values for One Pilot Lot

| Analyte (mg/L) | Instrument System | Level 1 (normal) (Lot 121603N) | Level 2 (abnormal) (Lot 031206A) |
| --- | --- | --- | --- |
| Total cholesterol | | | |
| | Cobas Mira | 235 | 307 |
| | Abaxis Piccolo | 183 | 244 |
| | Olympus AU5200/5400 | 194 | 253 |
| HDL cholesterol | | | |
| | Cobas Mira | 53 | 89 |
| | Abaxis Piccolo | 32 | 52 |
| | Olympus AU5200/5400 | 41 | 62 |
| LDL cholesterol | | | |
| | Cobas Mira | 142 | 191 |
| | Abaxis Piccolo | 126 | 151 |
| Triglycerides | | | |
| | Cobas Mira | 129 | 198 |

{3}

Page 4 of 4

| | Abaxis Piccolo | 142 | 217 |
| --- | --- | --- | --- |
| | Olympus
AU5200/5400 | 134 | 198 |
| Apo A | | | |
| | Cobas Mira | 148 | 267 |
| Apo B | | | |
| | Cobas Mira | 119 | 163 |
| CRP | | | |
| | Beckman Coulter
Immage | 0.16 | 0.21 |

**M. Conclusion:**

The submitted information in this premarket notification is complete and supports a substantial equivalence decision.