ABBOTT ARCHITECT LH CALIBRATORS

K111023 · Abbott Laboratories · JIT · Jun 10, 2011 · Clinical Chemistry

Device Facts

• Record ID: K111023
• Device Name: ABBOTT ARCHITECT LH CALIBRATORS
• Applicant: Abbott Laboratories
• Product Code: JIT · Clinical Chemistry
• Decision Date: Jun 10, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1150
• Device Class: Class 2

Indications for Use

The ARCHITECT LH Calibrators are for the calibration of the ARCHITECT i System when used for the quantitative determination of human luteinizing hormone (LH) in human serum and plasma. For prescription use only.

Device Story

ARCHITECT LH Calibrators consist of six liquid, ready-to-use bottles (levels A-F) containing human luteinizing hormone (LH) in phosphate buffer with protein stabilizers and preservatives (ProClin 300, ProClin 950). Used on ARCHITECT i2000SR analyzer by laboratory professionals to calibrate the system for quantitative LH measurement in human serum and plasma. Calibrators are traceable to WHO International Standard 80/552. Provides reference points for the analyzer to establish a calibration curve, ensuring accurate quantitative results for patient samples.

Clinical Evidence

No clinical data. Bench testing only. Stability established via accelerated and real-time studies (12-month shelf-life, 4-month open-vial). Traceability confirmed against WHO International Standard 80/552.

Technological Characteristics

Liquid calibrator set (6 levels: 0, 1.0, 3.5, 15, 50, 250 mIU/mL). Composition: human LH, phosphate buffer, protein stabilizers, ProClin 300, ProClin 950. Traceable to WHO 80/552. Designed for use on ARCHITECT i2000SR analyzer.

Indications for Use

Indicated for the calibration of the ARCHITECT i System for the quantitative determination of human luteinizing hormone (LH) in human serum and plasma.

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

• Architect LH calibrators (k032458)

Submission Summary (Full Text)

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

A. 510(k) Number:
k111023

B. Purpose for Submission:
New device

C. Measurand:
Calibrator materials for luteinizing hormone (LH)

D. Type of Test:
Not applicable

E. Applicant:
Abbott Laboratories

F. Proprietary and Established Names:
ARCHITECT LH Calibrators

G. Regulatory Information:

| Product Code | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| JIT | Class II | 21 CFR § 862.1150, Calibrator | Clinical Chemistry (75) |

H. Intended Use:

1. Intended use(s):
See indications for use below.

2. Indication(s) for use:
The ARCHITECT LH Calibrators are for the calibration of the ARCHITECT i System when used for the quantitative determination of human luteinizing hormone (LH) in human serum and plasma.

3. Special conditions for use statement(s):
For prescription use only.

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4. Special instrument requirements:
ARCHITECT i2000SR analyzer

I. Device Description:
The ARCHITECT LH calibrators consists of six bottles of calibrators (Cal A through F), with 4.0 mL of different concentrations of human luteinizing hormone (LH) in each bottle (0, 1.0, 3.5, 15, 50, and 250 mIU/mL). The calibrators are supplied as a ready to use liquid, requiring no reconstitution or dilution. They contain phosphate buffer with protein stabilizers, luteinizing hormone (LH), and preservatives (ProClin 300 and ProClin 950).

All human source materials has been tested using FDA cleared or approved methods and found to be nonreactive for HbsAg, HIV-Ag or HIV-RNA, anti-HIV-1/2, and anti-HCV.

J. Substantial Equivalence Information:

| Predicate device name | Predicate 510(k) number |
| --- | --- |
| Architect LH calibrators | k032458 |

Comparison with predicate:

| Similarities and Differences | | |
| --- | --- | --- |
| Item | New Device | Predicate Device (k032458) |
| Indications for Use | Same | For the calibration of the ARCHITECT i System when used for the quantitative determination of human luteinizing hormone (LH) in human serum and plasma. |
| Analyte | Same | luteinizing hormone (LH) |
| Number of Levels | 6 levels (A to F)
Note: Matching of calibrators with reagents and controls is not required. | 2 levels (level 1 and 2)
Note: Calibrators must be used with matched reagents and controls per labeling. |
| Standardization | The calibrators are referenced to the World Health Organization (WHO) Luteinizing Hormone (LH) Human, Pituitary 2nd International Standard 80/552.
Note: Calibrators B-F are manufactured by dilution. | The calibrators are manufactured by dilution and referenced to the World Health Organization (W.H.O.) Luteinizing Hormone (LH) Human, Pituitary 2nd International Standard 80/552 at each Concentration. |
| Composition | Calibrators B-F: Luteinizing | Calibrators 1-2: Luteinizing |

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| | hormone (from human pituitary) - changed vendor code | hormone (from human pituitary) |
| --- | --- | --- |
| | Calibrators A-F: Diluent: Phosphate buffer with protein stabilizers (bovine) | Calibrators 1-2: Diluent: Calf serum |
| | Calibrators A-F: Preservatives: ProClin 300 and ProClin 950 | Calibrators A-F: Preservatives: Sodium azide |

K. Standard/Guidance Document Referenced (if applicable):
None were 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
ARCHITECT LH calibrators are prepared gravimetrically using human luteinizing hormone (LH) and are traceable to the WHO International Standard 80/552.

Value Assignment
ARCHITECT LH calibrators are manufactured using human luteinizing hormone (LH) and the concentration values are assigned against internal reference standards. The internal reference standards are assigned against the WHO International standard 80/552. The concentration values of the working calibrators were assigned by testing multiple times on one Architect i2000SR analyzer using one lot of reagent. The sponsor's protocol and acceptance criteria was reviewed and found to be acceptable.

Stability:
Stability of the calibrators is determined by accelerated stability study using the Architect i instrument. Real-time stability study is still on-going. Based on the real-time stability study the sponsor determined that the calibrators have a

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shelf-life stability of 12 months when stored at 2-8°C and an open-vial stability of 4 months when stored at 2-8°C. The sponsor’s protocol and acceptance criteria was reviewed and found to be acceptable.

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):
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.