WAKO AUTO KIT PREALBUMIN, WAKO AUTOKIT PREALBUMIN CALIBRATOR SET, PREALBUMIN CONTROL SET

K040226 · Wako Chemicals USA, Inc. · JIT · Mar 25, 2004 · Clinical Chemistry

Device Facts

• Record ID: K040226
• Device Name: WAKO AUTO KIT PREALBUMIN, WAKO AUTOKIT PREALBUMIN CALIBRATOR SET, PREALBUMIN CONTROL SET
• Applicant: Wako Chemicals USA, Inc.
• Product Code: JIT · Clinical Chemistry
• Decision Date: Mar 25, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1150
• Device Class: Class 2

Indications for Use

The Wako Prealbumin Calibrator Set is intended to be used in the Wako Prealbumin test system to establish points of reference that are to be used in determination of values in the measurement of prealbumin in human serum or plasma. The Wako Prealbumin Control Set is intended to be used in the Wako Prealbumin Test System to estimate test precision and detect systematic analytical deviations that may arise from reagent or analytical instrument variation.

Device Story

Wako Prealbumin Calibrator Set and Control Set are liquid, ready-to-use materials derived from human serum spiked with human prealbumin. Calibrator set includes 5 levels; control set includes 2 levels. Used in clinical laboratory settings to calibrate prealbumin assays and monitor test precision/systematic analytical deviations. Calibrators establish reference points for quantitative measurement; controls verify assay performance. Traceable to CRM470 standard via internal primary standards. Values verified via replicate testing on Hitachi 917s analyzer. Supports clinical decision-making by ensuring accuracy and reliability of prealbumin test results.

Clinical Evidence

No clinical data. Bench testing only. Performance verified via gravimetric preparation and replicate testing (n=21) on a Hitachi 917s analyzer to confirm targeted values and ranges. Real-time, open-vial stability studies support manufacturer claims.

Technological Characteristics

Materials: Human serum matrix spiked with human prealbumin. Form: Liquid, ready-to-use. Calibrator levels: 5. Control levels: 2. Traceability: Internal primary standard traceable to CRM470. Verification method: Replicate testing on Hitachi 917s analyzer.

Indications for Use

Indicated for use in clinical laboratory settings to calibrate and monitor the precision of the Wako Prealbumin Test System for measuring prealbumin levels in human serum or plasma 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:
k040226

B. Analyte:
Prealbumin

C. Type of Test:
Calibrators and quality control material for quantitative Prealbumin
immunoturbidometric assay

D. Applicant:
Wako Chemicals, USA, Inc.

E. Proprietary and Established Names:
Prealbumin Calibrator Set
Prealbumin Control Set

F. Regulatory Information:
1. Regulation section:
21 CFR § 862.1150, Calibrator
862.1660, Quality control material (assayed and unassayed)
2. Classification:
Class II, Class I
3. Product Code:
JIT, Calibrator, secondary
JJX, Single (specified) analyte controls (assayed and unassayed)
4. Panel:
Clinical Chemistry (75)

G. Intended Use:
1. Intended Use:
The Wako Prealbumin Calibrator Set is intended to be used in the Wako Prealbumin test system to establish points of reference that are to be used in determination of values in the measurement of prealbumin in human serum or plasma.

The Wako Prealbumin Control Set is intended to be used in the Wako Prealbumin Test System to estimate test precision and detect systematic analytical deviations that may arise from reagent or analytical instrument variation.

{1}

Page 2 of 4

2. Indication(s) for use:
See intended use.

3. Special condition for use statement(s):
The assay to be calibrated is for prescription use only

4. Special instrument Requirements:
Not applicable

## H. Device Description:

The Wako Prealbumin Calibrator set consists of 5 levels of calibration material. The calibrators are provided ready-to-use. The prealbumin control set consists of 2 ready-to-use levels of quality control material.

## I. Substantial Equivalence Information:

1. Predicate device name(s):
Wako Lipase Calibrator
Wako Complement Control

2. Predicate k number(s):
k001002
k960874

3. Comparison with predicate:
Calibrator Set:

| Similarities | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Intended use | Calibration for prealbumin testing | Calibration for Lipase testing |
| Differences | | |
| Item | Device | Predicate |
| Levels | 5 levels | Single level |
| Form provided | Liquid | lyophilized |

Control Set:

| Similarities | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Intended use | Quality control for prealbumin assay | Quality control for complement activity |
| Matrix | Human serum | Human serum |
| Levels | 2 levels | 2 levels |
| Differences | | |
| Item | Device | Predicate |
| Form provided | Liquid | lyophilized |

## J. Standard/Guidance Document Referenced (if applicable):

None referenced

{2}

Page 3 of 4

K. Test Principle:
Not applicable. This review concerns calibrators and controls for a Class I exempt device.

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):
The Wako prealbumin calibrators are prepared gravimetrically by adding human prealbumin to a human serum matrix to the following targeted values: 5, 10, 20, 40, and 60 mg/dL prealbumin. The calibrators are traceable to an internal primary standard which is traceable to the CRM470 standard. Values are verified by multiple replicate testing on a Hitachi 917s analyzer.
The Wako prealbumin controls are prepared gravimetrically by adding human prealbumin to a human serum matrix to the following targeted ranges: 10-20 mg/dL prealbumin and 35-45 mg/dL prealbumin. The controls are traceable to an internal primary standard which is traceable to the CRM470 standard. Values are verified by replicate testing (n=21) on a Hitachi 917s analyzer.
Real time, open vial stability studies are described and support the manufacturer's stability claim.
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.

{3}

Page 4 of 4

c. Other clinical supportive data (when a and b are not applicable):
Not applicable.

4. Clinical cut-off:
Not applicable.

5. Expected values/Reference range:
Not applicable.

M. Conclusion:
I recommend that the Wako Prealbumin Calibrator Set and the Wako Prealbumin Control Set are substantially equivalent to the legally marketed predicate devices.