← Product Code [JIT](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIT) · K032285

# OLYMPUS PREALBUMIN CALIBRATOR, ODR3029 (K032285)

_Olympus America, Inc. · JIT · Aug 21, 2003 · Clinical Chemistry · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIT/K032285

## Device Facts

- **Applicant:** Olympus America, Inc.
- **Product Code:** [JIT](/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIT.md)
- **Decision Date:** Aug 21, 2003
- **Decision:** SESE
- **Submission Type:** Abbreviated
- **Regulation:** 21 CFR 862.1150
- **Device Class:** Class 2
- **Review Panel:** Clinical Chemistry

## Indications 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. 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).

## Regulatory 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)

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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

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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

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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.

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**Source:** [https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIT/K032285](https://fda.innolitics.com/submissions/CH/subpart-b%E2%80%94clinical-chemistry-test-systems/JIT/K032285)

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