OLYMPUS LYOPHILIZED CALIBRATOR, MODELS DR0070 AND DR0071

K032665 · Olympus America, Inc. · JIX · Nov 21, 2003 · Clinical Chemistry

Device Facts

• Record ID: K032665
• Device Name: OLYMPUS LYOPHILIZED CALIBRATOR, MODELS DR0070 AND DR0071
• Applicant: Olympus America, Inc.
• Product Code: JIX · Clinical Chemistry
• Decision Date: Nov 21, 2003
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 862.1150
• Device Class: Class 2

Indications for Use

The Olympus Lyophilized Calibrator is a two level general purpose chemistry calibrator designed to provide suitable calibration levels for OLYMPUS analyzers employing the OLYMPUS Methodologies.

Device Story

Olympus Lyophilized Calibrator functions as a two-level chemistry calibrator; used to establish calibration curves for OLYMPUS analyzers. Device is a lyophilized product; reconstituted for use in clinical laboratory settings by trained laboratory personnel. Provides reference values for OLYMPUS methodologies to ensure accuracy of patient sample testing. Benefits patient by ensuring reliable, standardized diagnostic results across chemistry assays.

Clinical Evidence

No clinical data. Bench testing only. Performance is established through analytical validation protocols, including 10-replicate runs per analyte, comparison against NIST/CAP reference materials, and adherence to precision goals (33% of CLIA/CAP total allowable error).

Technological Characteristics

Two-level lyophilized human serum-based calibrator; includes diluent. Analyte constituents include albumin, bicarbonate, bilirubin, calcium, cholesterol, creatinine, glucose, inorganic phosphorous, iron, magnesium, total protein, triglyceride, UIBC, urea nitrogen, and uric acid. Designed for use on Olympus clinical chemistry analyzers. Value assignment is traceable to national standards.

Indications for Use

Indicated for use as a two-level general-purpose chemistry calibrator for Olympus clinical chemistry analyzers to establish reference values for system assays.

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
DEVICE ONLY TEMPLATE

A. 510(k) Number:
K032665

B. Analyte:
Multi-Analyte Calibrator

C. Type of Test:
Not Applicable

D. Applicant:
OLYMPUS AMERICA, INC.

E. Proprietary and Established Names:
OLYMPUS LYOPHILIZED CALIBRATOR, MODELS DR0070 AND DR0071

F. Regulatory Information:
1. Regulation section:
21CFR §862.1150 -Calibrator.
2. Classification:
2
3. Product Code:
JIX
4. Panel:
Chemistry (75)

G. Intended Use:
1. Indication(s) for use:
The Olympus Lyophilized Calibrator is a two level general purpose chemistry calibrator designed to provide suitable calibration levels for OLYMPUS analyzers employing the OLYMPUS Methodologies.
2. Special condition for use statement(s):
Not Applicable
3. Special instrument Requirements:
Olympus series of chemistry analyzers

H. Device Description:
The Olympus Lyophilized Multi-Analyte calibrator is a Two Level, Liquid Human Serum based product for use on the Olympus family of Clinical Chemistry Analyzers. The calibrator is supplied in two formats.

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| DR0070 | DR0071 |
| --- | --- |
| 6x5mL Level I Lyophilized Human Serum | 6x10mL Level I Lyophilized Human Serum |
| 6x6mL Level I Diluent | 6x11mL Level I Diluent |
| 6x5mL Level II Lyophilized Human Serum | 6x10mL Level II Lyophilized Human Serum |
| 6x6mL Level II Diluent | 6x11mL Level II Diluent |

Both kit formats (DR0070 and DR0071) contain the same mixture of constituents in different volumes. Both formats are manufactured in one batch and the assigned values are the same regardless of the fill volume in the vials. The diluent and lyophilized vial labels are clearly marked with the level number. The assigned values in each level of calibrator are determined by Olympus for each production lot using a documented test and validation protocol.

The current validated constituents and target values are as follows:

| Constituent | Units | Level I Target Value and (Range) | Level II Target Value and (Range) |
| --- | --- | --- | --- |
| Albumin | g/dL | 2.4 (2.1-2.7) | 4.0 (3.6-4.4) |
| Bicarbonate | mEq/L | 20 (18-22) | 40 (36-44) |
| Bilirubin, Direct | mg/dL | 2.5 (2.25-2.75) | |
| Bilirubin, Total | mg/dL | 6.5 (5.85-7.15) | |
| Calcium (Arsenazo Application)* | mg/dL | 8.0 (7.2-8.8) | 12.0 (11.5-12.5) |
| Calcium (OPC Application) | mg/dL | 8.0 (7.2-8.8) | 12.0 (11.5-12.5) |
| Cholesterol | mg/dL | | 220 (198-242) |
| Creatinine | mg/dL | | 6.0 (5.4-6.6) |
| Creatinine STAT* | mg/dL | | 6.0 (5.4-6.6) |
| Glucose | mg/dL | | 250 (225-275) |
| Glucose STAT* | mg/dL | | 250 (225-275) |
| Inorganic Phosphorous | mg/dL | | 5.0 (4.5-5.5) |
| Iron | ug/dL | 300 (270-330) | |
| Magnesium | mg/dL | | 3.0 (2.7-3.3) |
| | mEq/L | | 2.5 (2.25-2.75) |
| Total Protein | g/dL | | 7.2 (6.5-7.9) |
| Triglyceride | mg/dL | | 250 (225-275) |
| UIBC | ug/dL | | 270 (243-297) |
| Urea Nitrogen (BUN) | mg/dL | | 50 (45-55) |
| Urea Nitrogen STAT* | mg/dL | | 50 (45-55) |
| Uric Acid | mg/dL | | 8.0 (7.2-8.8) |

*These assays not available for AU5200 Analyzer

These target calibrator values are set near the medical decision point as well as across and above the expected normal reference range.

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# I. Substantial Equivalence Information:

1. Predicate device name(s):
Olympus Liquid Multi-Analyte Calibrator predicate device

2. Predicate K number(s):
K863095

3. Comparison with predicate:

| | Olympus Lyophilized Multi-Analyte Calibrator | Olympus Liquid Multi-Analyte Calibrator (PREDICATE) | Olympus Lyophilized Multi-Analyte Calibrator (PREDICATE) |
| --- | --- | --- | --- |
| Intended Use | Calibrator | Calibrator | Calibrator |
| Analyte Constituents | Albumin
Bicarbonate
Bilirubin, Direct
Bilirubin, Total
Calcium (Arsenazo)
Calcium (OPC)
Cholesterol
Creatinine
Creatinine STAT
Glucose
Glucose STAT
Inorganic Phosphorous
Iron
Magnesium
Total Protein
Triglyceride
UIBC
Urea Nitrogen (BUN)
Urea Nitrogen STAT
Uric Acid | Albumin
Bicarbonate
Calcium (Arsenazo)
Calcium (OPC)
Cholesterol
Creatinine
Creatinine STAT
Glucose
Glucose STAT
Inorganic Phosphorous
Magnesium
Magnesium
Total Protein
Triglyceride
Urea Nitrogen (BUN)
Urea Nitrogen STAT
Uric Acid | Albumin
Bicarbonate
Bilirubin, Direct
Bilirubin, Total
Calcium
Chloride
Cholesterol
Creatinine
Creatinine STAT
Glucose
Glucose STAT
Inorganic Phosphorous
Iron
Magnesium
Potassium
Sodium
Total Protein
Triglyceride
UIBC
Urea Nitrogen (BUN)
Urea Nitrogen STAT
Uric Acid |
| Matrix Base | Human Serum | Bovine Serum | Human Serum |
| Form | Lyophilized Human Serum with diluent mixture | Liquid | Lyophilized Human Serum with diluent mixture |
| Volume | 5 mL per vial (DR0070)
10 mL per vial (DR0071) | 5 mL per vial | 25mL per vial |
| Levels | 2 Levels | 1 Level | 2 Levels |

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

K. Test Principle:
Not Applicable

L. Performance Characteristics (if/when applicable):
1. Analytical performance:
a. Precision/Reproducibility:
Not Applicable
b. Linearity/assay reportable range:
Not Applicable
c. Traceability (controls, calibrators, or method):
Olympus purchases calibrator material manufactured by outside vendors. The required number of samples of the lot is to be forwarded to Olympus' Technical Operations and Product Support (TOPS) with a copy of the certificate of analysis. Any calibrator that is derived, or has components derived, from a human source (serum, plasma, etc) must be tested for reactivity to HIV-1 and Hepatitis B. The Certificate of Analysis must contain a statement of the non-reactivity of the calibrator for these infectious agents. The calibrators are intended to be used on the various Olympus clinical chemistry analyzers as a means for establishing reference values for Olympus clinical chemistry system assays. The following procedures are to be followed when assigning chemistry values for these calibrators. The assigned values are published in the package insert accompanying the product upon approval at DSG.

Prepare the calibrator material as per the manufacturer's instructions. Calibrate the chosen analyzer with the current calibrator (traceable to a national standard) and immediately follow with 10 replicates of the unknown calibrator for each analyte. Include any other appropriate material in duplicate to confirm proper functioning of analyzer and assay (Olympus assayed controls, linearity material, etc.)

A run is defined as 10 replicates for each analyte. Perform at least five separately calibrated runs for a minimum total of 50 data points for the calibrator and 10 data points for each control. Retain all printouts for the batch file.

The current lot of calibrator should be assayed over the open shelf life of the material and this stability verified by the manufacturer for subsequent lots.

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At the conclusion of the testing period, calculate the mean, the standard deviation (SD), and coefficient of variation (CV) for each analyte and each material analyzed. The SD and CV are measurements of the precision of the test mean and reflect the performance of the testing; Olympus America has established performance goals for total precision for each analyte that must be met. Total precision goals are 33% of total allowable error goals from CLIA and CAP.

The data used to generate the preliminary calibrator value will be reviewed and evaluated in detail by the Senior TOPS Associate. This person may choose to make adjustments or normalizations to the published value of the primary reference material and/or the current calibrator published value. This adjustment will be for all materials within a single calibrated run by the use of a constant factor or addend traceable to the primary reference material or the current calibrator.

Confirmation of Final Assigned Values:

Calibrate the chosen analyzer using the preliminary calibrator values for the new lot of calibrator.

Run, in replicates of 10, the preliminary calibrator, and, in triplicate as unknowns, the primary standard, current assayed controls in use, linearity standards, and any NIST or CAP reference material that is available.

Calibrator values are acceptable if recovery of NIST traceable reference material standards and the calibrator run as an unknown recovers 100% ±5%.

Repeat a run with the assigned calibrator (n=10) as an unknown at least once more, recalibrating each time, giving a minimum of 20 data points for the calibrator.

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:

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a. Clinical sensitivity: Not Applicable
b. Clinical specificity: Not Applicable

4. Clinical cut-off: Not Applicable
5. Expected values/Reference range: Not Applicable

**M. Conclusion:**
The information and data provided by OLYMPUS AMERICA, INC. supports a Substantial Equivalence (SE) determination to other CALIBRATOR, MULTI-ANALYTE MIXTURE regulated under 21 CFR §862.1150 - Calibrator.