VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 99, VITROS CHEMISTRY PRODUCTS AAT/HPT PERFORMANCE VERIFIER I, II, AND III

K060940 · Ortho-Clinical Diagnostics, Inc. · JIX · Apr 24, 2006 · Clinical Chemistry

Device Facts

• Record ID: K060940
• Device Name: VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 99, VITROS CHEMISTRY PRODUCTS AAT/HPT PERFORMANCE VERIFIER I, II, AND III
• Applicant: Ortho-Clinical Diagnostics, Inc.
• Product Code: JIX · Clinical Chemistry
• Decision Date: Apr 24, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1150
• Device Class: Class 2

Indications for Use

VITROS Chemistry Products Calibrator Kit 99 is used to calibrate VITROS 5, 1 FS Chemistry systems for the quantitative measurement of proteins in body fluids. VITROS Chemistry Products AAT/HPT Performance Verifiers I, II, III are assayed controls used to monitor performance of protein measurements in body fluids with VITROS 5, 1 FS Chemistry systems.

Device Story

VITROS Chemistry Products Calibrator Kit 99 and AAT/HPT Performance Verifiers are processed human serum-based products containing inorganic salts, buffers, and preservatives. Calibrator Kit 99 provides a five-level set for system calibration; Performance Verifiers provide a three-level set for monitoring measurement performance. Used exclusively with VITROS 5, 1 FS Chemistry systems, these products support the quantitative immunoturbidimetric assay of alpha-1 antitrypsin and haptoglobin. The system uses these materials to establish and verify the accuracy of protein measurements in clinical laboratory settings. By ensuring proper calibration and control, the device enables healthcare providers to obtain reliable quantitative results for patient protein levels, facilitating clinical assessment of associated disease states.

Clinical Evidence

No clinical data. Bench testing only.

Technological Characteristics

Processed human serum matrix with added inorganic salts, buffers, and preservatives. Liquid, ready-to-use format. Five-level calibrator set; three-level control set. Standardized to BAM-IRMM-LGC ERM-DA 470 reference material. Designed for use with VITROS 5, 1 FS Chemistry systems (random access, fully automated clinical chemistry analyzer).

Indications for Use

Indicated for use as calibrators and assayed controls for the quantitative measurement of alpha-1 antitrypsin (AAT) and haptoglobin (HPT) in body fluids using VITROS 5, 1 FS Chemistry systems.

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.

Predicate Devices

• VITROS Chemistry Products Calibrator Kit 99 (K052819)
• VITROS Chemistry Products AAT Performance Verifiers I, II, and III (K052819)

Submission Summary (Full Text)

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# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY

A. 510(k) Number:
k060940

B. Purpose for Submission:
Addition of Haptoglobin to an existing device.

C. Measurand:
Alpha-1 Antitrypsin
Haptoglobin

D. Type of Test:
Quantitative immunoturbidimetric assay

E. Applicant:
Ortho-Clinical Diagnostics, Inc.

F. Proprietary and Established Names:
VITROS Chemistry Products Calibrator Kit 99
VITROS Chemistry Products AAT/HPT Performance Verifiers I, II, and III

G. Regulatory Information:
1. Regulation section:
21CFR§ 862.1660, Quality Control Material (Assayed and Unassayed)
21CFR§ 862.1150, Calibrator
2. Classification:
Calibrator - Class II
Quality control material - Class I
1. Product code:
JJX, Single (Specified) Analyte Controls (Assayed and Unassayed)
JIX, Calibrator, Multi-Analyte Mixture
4. Panel:
Chemistry (75)

H. Intended Use:
1. Intended use(s):
VITROS Chemistry Products Calibrator Kit 99 is used to calibrate VITROS 5, 1 FS Chemistry systems for the quantitative measurement of proteins in body fluids.

VITROS Chemistry Products AAT/HPT Performance Verifiers I, II, III are assayed controls used to monitor performance of protein measurements in body fluids with VITROS 5, 1 FS Chemistry systems.

2. Indication(s) for use:
Same as above
3. Special conditions for use statement(s):
For prescription use only.
4. Special instrument requirements:
For use in VITROS 5, 1 FS Chemistry systems (k031924).

I. Device Description:

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The VITROS Chemistry Products Calibrator Kit 99 is a five level set of fluids used to calibrate VITROS 5, 1 FS Chemistry systems for the quantitative measurement of $\alpha 1$ -antitrypsin (AAT), and haptoglobin (HPT) using VITROS Chemistry Products AAT and HPT Reagents. VITROS Chemistry Products Calibrator 99 is prepared from processed human serum to which inorganic salts, buffers, and preservatives have been added.

The VITROS Chemistry Products AAT/HPT Performance Verifiers I, II, and III is a three level set of assayed liquid controls used to monitor the performance of $\alpha 1$ -antitrypsin (AAT), and haptoglobin (HPT) measurements, using VITROS Chemistry Products AAT and HPT Reagents with the VITROS 5, 1 FS Chemistry systems. The VITROS AAT/HPT Performance Verifiers are prepared from processed human serum to which inorganic salts, buffers, and preservatives have been added.

# J. Substantial Equivalence Information:

1. Predicate device name(s):

VITROS Chemistry Products Calibrator Kit 99

VITROS Chemistry Products AAT Performance Verifiers I, II, and III

2. Predicate $510(\mathbf{k})$ number(s):

K052819

3. Comparison with predicate:

| Similarities | | |
| --- | --- | --- |
| Item | Device | Predicate |
| | VITROS Calibrator Kit 99 (New) | VITROS Calibrator Kit 99 (Current) |
| Standardization | BAM-IRMM-LGC (Institute for reference Methods and Materials/Laboratory of the Gov’t Chemist) ERM-DA 470 | Same |
| Sample type | Serum | Same |
| Number of levels | Five levels | Same |
| Matrix | Prepared from processed human serum to which salts, buffers and preservatives have been added | Same |
| Format | Liquid ready to use. | Same |
| Differences | | |
| --- | --- | --- |
| Item | Device | Predicate |
| Intended Use | VITROS Chemistry Products Calibrator Kit 99 is used to calibrate VITROS 5, | VITROS Chemistry Products Calibrator Kit 99 is used to calibrate |
| | VITROS 5, 1 FS | VITROS 5, 1 FS |

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| Differences | | |
| --- | --- | --- |
| Item | Device | Predicate |
| | VITROS AAT/HPT Performance Verifiers I, II, III | VITROS 5, 1 FS Chemistry systems for the quantitative measurement of α1-antitrypsin (AAT). |
| Analytes | α1-antitrypsin (AAT), and haptoglobin (HPT) | α1-antitrypsin (AAT), |
| Similarities | | |
| --- | --- | --- |
| Item | Device | Predicate |
| | VITROS AAT/HPT Performance Verifiers I, II, III | VITROS AAT Performance Verifiers I, II, III |
| Standardization | BAM-IRMM-LGC (Institute for reference Methods and Materials/Laboratory of the Gov’t Chemist) ERM-DA 470 | Same |
| Sample type | Serum | Same |
| Number of levels | Three levels | Same |
| Matrix | Prepared from processed human serum to which salts, buffers and preservatives have been added | Same |
| Format | Liquid ready to use. | Same |
| Differences | | |
| Intended Use | VITROS Chemistry Products Calibrator Kit 99 is used to calibrate VITROS 5, 1 FS Chemistry systems for the quantitative measurement of proteins in body fluids. | VITROS Chemistry Products Calibrator Kit 99 is used to calibrate VITROS 5, 1 FS Chemistry systems for the quantitative measurement of α1-antitrypsin (AAT). |
| Analytes | α1-antitrypsin (AAT), and haptoglobin (HPT) | α1-antitrypsin (AAT), |

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

None referenced.

# L. Test Principle:

The VITROS Chemistry Products Calibrator Kit 99 (New) and VITROS Chemistry Products AAT/HPT Performance Verifiers I, II, III are to be used with VITROS 5, 1 FS Chemistry systems (k031924). The VITROS 5, 1 FS Chemistry systems is a random access, fully automated clinical chemistry analyzer, intended for use in the in vitro quantitative measurement of a variety

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of analytes in certain biological fluids. The analyzer operates in conjunction with reagents, calibrators and controls designed for use with the system.

## M. Performance Characteristics (if/when applicable):

### 1. Analytical performance:

**a. Precision/Reproducibility:**
Not applicable.
The new device is for the addition of the haptoglobin analyte to Calibrator Kit 99 and Performance Verifiers I, II, III. Haptoglobin immunological test system (§866.5460) is a Class II exempt from premarket notification procedures. Refer to predicate device (k052819) for precision/reproducibility studies of AAT.

**b. Linearity/assay reportable range:**
Not applicable.
The new device is for the addition of the haptoglobin analyte to Calibrator Kit 99 and Performance Verifiers I, II, III. Haptoglobin immunological test system (§866.5460) is a Class II exempt from premarket notification procedures. Refer to predicate device (k052819) for linearity studies of AAT.

**c. Traceability, Stability, Expected values (controls, calibrators, or methods):**
The values assigned to the VITROS Chemistry Products Calibrator Kit 99 for AAT/HPT are traceable to BAM-IRMM-LGC (Bundesanstalt für Materialforschung und-prüfung/Institute for Reference Methods and Materials/Laboratory of the Gov't Chemist) ERM-DA 470 Reference Material. A five level set of calibrators are prepared through VITROS 5, 1 FS Chemistry System on-analyzer dilution of ERM-DA470 and are used to calibrate the Manufacturer's Selected Measurement Procedure, a VITROS 5, 1 FS Chemistry System analyzer using VITROS Chemistry Products AAT or HPT Reagents, respectively. The calibration standards and the VITROS chemistry System are used to support value assignment for working calibrators, VITROS Chemistry Products Calibrator Kit 99 (Master Lot).

The Master Lot and the Manufacturer's Selected Measurement Procedure, a VITROS 5, 1 FS Chemistry System analyzer using VITROS Chemistry Products AAT or HPT Reagents, respectively transfers the trueness of the working calibrators to new product lots of the VITROS Chemistry Products AAT/HPT Reagent and VITROS Chemistry Products Calibrator Kit 99.

Calibrator Kit Stability – Unopened kit are stable until expiration date printed on the label when stored refrigerated at 2°-8°C. Opened vials are stable at ≤3 days when stored capped between 2°-8°C.

Performance Verifiers Stability – Unopened kit are stable until expiration date printed on the label when stored refrigerated at 2°-8°C. The stability of opened vials stored capped between 2°-8°C is up to 4 weeks.

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d. Detection limit:
Not applicable
The new device is for the addition of the haptoglobin analyte to Calibrator Kit 99 and Performance Verifiers I, II, III. Haptoglobin immunological test system (§866.5460) is a Class II exempt from premarket notification procedures. Refer to predicate device (k052819) for determination of detection limit.

e. Analytical specificity:
Not applicable.
The new device is for the addition of the haptoglobin analyte to Calibrator Kit 99 and Performance Verifiers I, II, III. Haptoglobin immunological test system (§866.5460) is a Class II exempt from premarket notification procedures. Refer to predicate device (k052819) for analytical specificity studies.

2. Comparison studies:
a. Method comparison with predicate device:
Not applicable.
The new device is for the addition of the haptoglobin analyte to Calibrator Kit 99 and Performance Verifiers I, II, III. Haptoglobin immunological test system (§866.5460) is a Class II exempt from premarket notification procedures. Refer to predicate device (k052819) for method comparison with predicate device.
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):
Not applicable

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.