OLYMPUS PREALBUMIN CALIBRATOR, ODR3029

K032285 · Olympus America, Inc. · JIT · Aug 21, 2003 · Clinical Chemistry

Device Facts

• Record ID: K032285
• Device Name: OLYMPUS PREALBUMIN CALIBRATOR, ODR3029
• Applicant: Olympus America, Inc.
• Product Code: JIT · Clinical Chemistry
• Decision Date: Aug 21, 2003
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 862.1150
• Device Class: Class 2

Intended Use

The Olympus Prealbumin Calibrator is a device designed to provide suitable calibration levels for OLYMPUS analyzers employing the OLYMPUS Prealbumin immunoturbidometric assay for Prealbumin determinations in human serum. Prescription Use Only

Device Story

Olympus Prealbumin Calibrator provides calibration levels for OLYMPUS analyzers; used in clinical laboratory settings by trained technicians; ensures accuracy of immunoturbidimetric assays for prealbumin in human serum; supports clinical decision-making regarding nutritional status or inflammatory response; device acts as reference material to establish calibration curves for automated analyzer systems.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Liquid-based calibrator for immunoturbidimetric assays; designed for use with OLYMPUS automated analyzer systems; Class II device (21 CFR 862.1150).

Indications for Use

Indicated for use as a calibration tool for OLYMPUS analyzers performing immunoturbidimetric assays for prealbumin in human serum samples.

Regulatory Classification

Identification

A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)

Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.

Submission Summary (Full Text)

{0}

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

A. 510(k) Number:
k032285

B. Analyte:
Prealbumin

C. Type of Test:
Immunoturbidometric

D. Applicant:
Olympus America Inc.

E. Proprietary and Established Names:
Olympus Prealbumin Calibrator

F. Regulatory Information:
1. Regulation section:
21CFR 862.1150 Calibrator
2. Classification:
Class II
3. Product Code:
JIT
4. Panel:
Clinical Chemistry

G. Intended Use:
1. Indication(s) for use:
The Olympus Prealbumin Calibrator is a device designed to provide suitable calibration levels for OLYMPUS analyzers employing the OLYMPUS Prealbumin immunoturbidometric assay for Prealbumin determinations in human serum.
2. Special condition for use statement(s):
Prescription Use Only
3. Special instrument Requirements:
OLYMPUS analyzers employing the immunoturbidometric assay for Prealbumin

H. Device Description:
The Olympus Prealbumin Calibrator consists of 5 bottles (2 mL each) labeled 1-5 with increasing concentrations of human prealbumin in a human serum matrix.

I. Substantial Equivalence Information:
1. Predicate device name(s):
Dade Behring Dimension Prealbumin Calibrator
2. Predicate K number(s):
k982292

{1}

Page 2 of 4

3. Comparison with predicate:

| Similarities | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Intended Use | Calibration for human prealbumin | Calibration for human prealbumin |
| Form | Liquid | Liquid |
| Differences | | |
| Item | Device | Predicate |
| Matrix Base | Human Serum | Bovine Albumin |
| Vial volume | 2 mL | 1 mL |
| Levels | 5 | 4 plus a Zero Calibrator |

J. Standard/Guidance Document Referenced (if applicable):
Guidance for Industry - Abbreviated 510(k) Submissions for In Vitro Diagnostic Calibrators

K. Test Principle:
Immunoturbidometric

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): Traceable to IFCC CRM 470
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):

4. Clinical cut-off: N/A

{2}

Page 3 of 4

5. Expected values/Reference range:
N/A

**M. Conclusion:**
Based upon the information provided for the file, I recommend that the Olympus Prealbumin calibrator is substantially equivalent to the predicate device.

{3}

Page 4 of 4