AUTOKIT TOTAL KETONE BODIES KIT (SERUM) AND WAKO KETONE BODY CALIBRATOR

K033860 · Wako Chemicals USA, Inc. · JIT · Apr 23, 2004 · Clinical Chemistry

Device Facts

• Record ID: K033860
• Device Name: AUTOKIT TOTAL KETONE BODIES KIT (SERUM) AND WAKO KETONE BODY CALIBRATOR
• Applicant: Wako Chemicals USA, Inc.
• Product Code: JIT · Clinical Chemistry
• Decision Date: Apr 23, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1150
• Device Class: Class 2

Indications for Use

The Wako Total Ketone Body Calibrators are intended to be used with the Wako Total Ketone Bodies and the Wako Autokit 3-HB test kits to establish points of reference that are used in the determination of values in the measurement of total ketone bodies and 3-HB in human serum or plasma. The calibrators are for Rx in vitro diagnostic use.

Device Story

Wako Total Ketone Body Calibrators; liquid, ready-to-use calibrators; two levels (40 μmol/L and 300 μmol/L 3-Hydroxybutyrate). Used in clinical laboratory settings with Wako Total Ketone Bodies and Wako Autokit 3-HB test kits on Wako 30R® instruments. Provides reference points for assay calibration; enables accurate quantification of ketone bodies in patient serum or plasma. Value assignment derived via molar extinction coefficient (K-factor) of NADH.

Clinical Evidence

No clinical data. Bench testing only. Real-time stability studies demonstrated that both calibrator levels remained within 1% of expected values over 15 months when stored at 10°C.

Technological Characteristics

Liquid, ready-to-use calibrators. Matrix: Goods Buffer, polyethylene glycol, sodium azide, and 3-Hydroxybutyrate. Two levels: 40 μmol/L and 300 μmol/L. Traceability established via molar extinction coefficient (K-factor) of NADH.

Indications for Use

Indicated for use as calibrators for the measurement of total ketone bodies and 3-hydroxybutyrate (3-HB) 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:
k033860

B. Purpose of the Submission:
New device

C. Analyte:
Hydroxybutyric Acid

D. Type of Test:
Calibrator

E. Applicant:
Wako Chemicals, USA, Inc.

F. Proprietary and Established Names:
Wako Total Ketone Body Calibrators

G. Regulatory Information:
1. Regulation section:
21 CFR 862.1150, Calibrators, Secondary
2. Classification:
II
3. Product Code:
JIT
4. Panel:
Chemistry (75)

H. Intended Use:
1. Intended use(s):
Refer to Indications for use.
2. Indication(s) for use:
The Wako Total Ketone Body Calibrators are intended to be used with the Wako Total Ketone Bodies and the Wako Autokit 3-HB test kits to establish points of reference that are used in the determination of values in the measurement of total ketone bodies and 3-HB in human serum or plasma.

{1}

Page 2 of 3

(Reviewer Note: 3-HB is a common abbreviation for 3-Hydroxybutyrate.)

3. **Special condition for use statement(s):**
The calibrators are for Rx in vitro diagnostic use.

4. **Special instrument requirements:**
Wako 30R®

I. **Device Description:**
The products consist of two levels of liquid ready to use calibrators. They consist of a matrix of Goods Buffer, polyethylene glycol and sodium azide and are prepared by adding 3-Hydroxybutyrate.

J. **Substantial Equivalence Information:**

1. **Predicate device name(s):**
Stanbio Standard, 1 mM Sodium D-3-Hydroxybutyrate (Formerly GDS)

2. **Predicate K number(s):**
k910108

3. **Comparison with predicate:**
Both are liquid based calibrators intended to provide reference points for ketone assays. They are intended to calibrate different assays made by different manufacturers.

K. **Standard/Guidance Document Referenced (if applicable):**
The sponsor did not reference any standards in their submission.

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 (controls, calibrators, or method):**

There are two levels of calibrators:
40 μmol/L and 300 μmol/L of 3-Hydroxybutyrate.

Calibrators are prepared by adding 3-Hydroxybutyrate to buffer.
The grade of chemicals utilized was not specified.

The value assignment and traceability is provided through use of the molar extinction coefficient (K-factor) of NADH.

{2}

Page 3 of 3

Results from Real Time Stability studies are summarized. The calibrators were evaluated for up to 15 months when stored at 10 degrees C and were both levels were within 1% of the expected value at all measurement times.

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. Clinical studies are not typically submitted for this device type.
b. Clinical specificity: Not applicable. Clinical studies are not typically submitted for this device type.
c. Other clinical supportive data (when a and b are not applicable):

4. Clinical cut-off: Not applicable.

5. Expected values/Reference range: Not applicable.

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