OLYMPUS LACTATE, OSR6193

K042406 · Olympus America, Inc. · JIT · Dec 3, 2004 · Clinical Chemistry

Device Facts

• Record ID: K042406
• Device Name: OLYMPUS LACTATE, OSR6193
• Applicant: Olympus America, Inc.
• Product Code: JIT · Clinical Chemistry
• Decision Date: Dec 3, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1150
• Device Class: Class 2

Indications for Use

The Olympus lactate calibrator is a device intended for medical purposes for use in the Olympus lactate test system to establish a standardized point of reference that is used in the determination of lactate values in human plasma and cerebrospinal fluid.

Device Story

Olympus Lactate Calibrator serves as a standardized reference material for the Olympus lactate test system. Used in clinical laboratory settings to calibrate assays for measuring lactate concentrations in human plasma and cerebrospinal fluid. Ensures accuracy and traceability of patient test results by providing a known value for system calibration. Operated by laboratory technicians; output used by clinicians to assess patient metabolic status.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Single-level liquid calibrator containing L-Lactate. 5 mL bottle format. Designed for use with Olympus AU family of analyzers. Traceable to primary internal standard of weighed purified material. Storage at 2-8 °C.

Indications for Use

Indicated for use in the Olympus lactate test system to establish a standardized point of reference for determining lactate values in human plasma and cerebrospinal fluid.

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)

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

A. 510(k) Number:
k042406

B. Purpose for Submission:
New Device

C. Measurand:
Calibrator for Lactic Acid (Lactate)

D. Type of Test:
Quantitative Immunoassay

E. Applicant:
Olympus America, Inc.

F. Proprietary and Established Names:
Olympus Lactate Calibrator

G. Regulatory Information:
1. Regulation section:
21 CFR § 862.1150 (Calibrator)
2. Classification:
Class II
3. Product code:
JIT
4. Panel:
75 Clinical Chemistry

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H. Intended Use:

1. Intended use / Indication(s) for use:

The Olympus lactate calibrator is a device intended for medical purposes for use in the Olympus lactate test system to establish a standardized point of reference that is used in the determination of lactate values in human plasma and cerebrospinal fluid.

2. Special conditions for use statement(s):

Prescription use only

3. Special instrument requirements:

Olympus AU family of analyzers only

I. Device Description:

The Olympus Lactate Calibrator contains L-Lactate and comes in ready-to-use liquid form in a 5 mL bottle. It is a single-level calibrator designed for use with Olympus analyzers only.

J. Substantial Equivalence Information:

1. Predicate device name(s):

Casco Standards Document Ammonia/Ethanol/Lactate Calibrator

2. Predicate 510(k) number(s):

k81436

3. Comparison with predicate:

| Similarities | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Preparation | Same | Liquid, ready to use |
| Storage | Same | 2 - 8 °C |

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| Differences | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Analytes | Lactate Only | Ammonia, Ethanol, Lactate |
| Number of Levels | One | Two |
| Number of Applicable Analyzers | Olympus AU family only | Multiple Analyzers |

K. Standard/Guidance Document Referenced (if applicable):

None Referenced

L. Test Principle:

Not Applicable

M. Performance Characteristics (if/when applicable):

1. Analytical performance:

a. Precision/Reproducibility:

Not Applicable.

b. Linearity/assay reportable range:

Not Applicable.

c. Traceability, Stability, Expected values (controls, calibrators, or methods):

Traceability. The sponsor states that the calibrator is traceable to a primary internal standard obtained from weighed purified material.

Shelf-life Stability. Shelf-life stability was established by calibrating the assay and analyzing controls in real time. Acceptance criteria were as follows: low control ≤ 10% CV, medium control ≤ 7% CV, and high control ≤ 5% CV. All criteria were met at 36 months; however, the sponsor has chosen to use 24 months as the shelf-life stability.

Opened Bottle Stability. To assess opened bottle stability, the sponsor analyzed the calibrator as an unknown in triplicate at day 0, day 60, and day 120 (storage at 4° C). The sponsor’s acceptance criteria were that the mean of the measurements must be ≤ 3% difference from the assigned value. The mean of the measured values met the sponsor’s acceptance criteria at day 120,

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establishing the opened bottle stability claim of 120 days as specified in the labeling.

**Value Assignment.** For value assignment, the assay is calibrated with a primary standard using previously released lots of lactate reagent. Included in the value assignment run are two levels of control (for validation of the run), a secondary standard (to check the commutatability of the standard), a primary standard (for supplemental run validation), a previous lot standard (to check the lot consistency), and 10 replicates of the calibrator lot to which a value is being assigned. If all control and standard values fall within range, the ten replicates of the new calibrator lot are averaged and the mean is assigned as the value.

d. Detection limit:
Not Applicable.

e. Analytical specificity:
Not Applicable.

f. Assay cut-off:
Not applicable.

2. Comparison studies:
a. Method comparison with predicate device:
Not Applicable.
b. Matrix comparison:
Not Applicable.

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

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4. Clinical cut-off:
Not Applicable.

5. Expected values/Reference range:
Not Applicable.

**N. Proposed Labeling:**
The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10.

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

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