PROGESTERONE STANDARD CALIBRATOR, ONE (1) ML OF PROGESTERONE IN A SALIVA-LIKE MATRIX AT A CONCENTRATION OF 2430 PG/ML.

K051012 · Salimetrics, LLC · JIT · Jul 19, 2005 · Clinical Chemistry

Device Facts

• Record ID: K051012
• Device Name: PROGESTERONE STANDARD CALIBRATOR, ONE (1) ML OF PROGESTERONE IN A SALIVA-LIKE MATRIX AT A CONCENTRATION OF 2430 PG/ML.
• Applicant: Salimetrics, LLC
• Product Code: JIT · Clinical Chemistry
• Decision Date: Jul 19, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1150
• Device Class: Class 2

Indications for Use

The salivary progesterone calibrator is a device intended for medical purposes to use in the calibration of the Salimetrics progesterone immunoassay and to establish points of reference that are used to determine the concentration of free progesterone in saliva. The salivary progesterone controls are devices intended for use in monitoring the performance of the salivary immunoassay of free progesterone in saliva.

Device Story

Salimetrics Progesterone Calibrator and Control are in vitro diagnostic reagents used to support salivary progesterone enzyme immunoassays. Calibrators establish reference points for quantification; controls monitor assay performance. Both are derived from synthetic progesterone suspended in a saliva-like matrix with non-mercury preservatives. Calibrators are provided in 1mL vials; controls are provided in 0.5mL vials at high (1000 pg/mL) and low (50.6 pg/mL) concentrations. Used in clinical or research laboratory settings by trained personnel. Output is used by healthcare providers to validate immunoassay results, ensuring accuracy in measuring free progesterone levels, which aids in clinical assessment of hormonal status.

Clinical Evidence

No clinical data. Bench testing only. Stability studies (real-time and accelerated) confirm 1.5-year stability for calibrators and 2.0-year stability for controls. Traceability established via weighing on balances calibrated to international standards and NIST-validated pipettes. Performance verified via immunoassay.

Technological Characteristics

Synthetic progesterone in saliva-like matrix; non-mercury preservative. Calibrator concentration: 2430 pg/mL; Control concentrations: 1000 pg/mL and 50.6 pg/mL. Requires microplate reader (450nm). Manufactured under GMP; balances/pipettes validated to NIST standards.

Indications for Use

Indicated for use as reference points and performance monitoring materials in salivary progesterone enzyme immunoassays for the measurement of free progesterone in saliva.

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}

1

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

A. 510(k) Number:
k051012

B. Purpose for Submission:
Notification of intent to manufacture and market the device: Salimetrics LLC
Progesterone Calibrator and Control.

C. Measurand:
Progesterone Calibrator and Control

D. Type of Test:
Calibrator and Control

E. Applicant:
Salimetrics LLC

F. Proprietary and Established Names:
Proprietary Name – Salimetrics LLC Progesterone Calibrator and Control
Established Name - Calibrator and Control

G. Regulatory Information:
1. Regulation section:
21 CFR 862.1150 Calibrator
21 CFR 862.1660 Control
2. Classification:
Class II – Calibrator
Class I – Controls

{1}

3. Product code:
JIT
JJY

4. Panel:
75, Chemistry

H. Intended Use:

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

2. Indication(s) for use:
The salivary progesterone calibrator is a device intended for medical purposes to use in the Salimetrics competitive enzyme immunoassay to establish points of reference that are used to determine values in the measurement of free progesterone in saliva.

The salivary progesterone controls are devices intended for use in monitoring the performance of the salivary immunoassay of free progesterone in saliva.

3. Special conditions for use statement(s):

4. Special instrument requirements:
For use with a Microplate reader capable of reading at 450nm.

I. Device Description:

The Salimetrics Saliva progesterone calibrator comes with the Salimetrics Saliva Progesterone Assay Kit and also may be sold separately. It is in a 1mL vial. The calibrator is derived from synthetic progesterone and is suspended in a saliva-like matrix with a non-mercury preservative.

The Salimetrics Saliva progesterone control is provided in 0.5 mL vials in two concentrations, a high control of 1000 pg/mL and a low control of 50.6 pg/mL. The control is derived from synthetic progesterone and is suspended in a saliva-like matrix with a non-mercury preservative.

J. Substantial Equivalence Information:

2

{2}

1. Predicate device name(s):

IBL (Immuno Biological Laboratories) Progesterone LIA

2. Predicate 510(k) number(s):

k040923

3. Comparison with predicate:

Salimetrics Progesterone Calibrator to the predicate device

| Device Characteristic | Salimetrics Progesterone Calibrator | Predicate Device |
| --- | --- | --- |
| Concentration | 2430 pg/mL | 1000 pg/mL |
| Matrix | Saliva-like matrix | Buffer, BSA, 0.1%NaN_{3} |
| Calibrator Range | 10 – 2430 pg/mL | 10 – 1000 pg/mL |
| Storage | 2-8°C | 2-8°C <-20°C |
| Stability | 1.5 years | >4wks >6months |

Salimetrics Progesterone Controls to the predicate device

| Device Characteristic | Salimetrics Progesterone Controls | Predicate Device Controls |
| --- | --- | --- |
| Concentration | 1000 pg/mL, 50.6 pg/mL | 200 pg/mL, 30 pg/mL |
| Matrix | Saliva-like matrix | Buffer, BSA, 0.1%NaN_{3} |
| Storage | 2-8°C | 2-8°C <20°C |
| Stability | 2.0 years | >4wks >6months |

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

FDA's Guidance for Industry, Abbreviated 510(k) Submission for In Vitro Diagnostic Calibrators; Final

FDA's Points to Consider Guidance Document on Assayed and Unassayed Quality Control Material; Draft

L. Test Principle:

Not applicable

M. Performance Characteristics (if/when applicable):

1. Analytical performance:

a. Precision/Reproducibility:

{3}

Not applicable

b. Linearity/assay reportable range:

Not applicable

c. Traceability, Stability, Expected values (controls, calibrators, or methods):

Based upon real time and accelerated stability studies, the Progesterone Calibrator is stable for 1.5 years.

The calibrator is prepared from starting progesterone standard (1000 ng/mL). The progesterone standard is of synthetic origin. The standard is prepared by accurately weighing on a balance calibrated by an independent company to standards traceable to international measurement standards. Salimetrics prepares the progesterone working calibrator (2430 pg/mL) via dilution with standard diluent, following GMP regulations. Pipettes and balances are independently validated to NIST standards. The calibrator performance is verified by immunoassay.

The controls are prepared from starting progesterone standard (1000 ng/mL). The progesterone standard is of synthetic origin. The standard is prepared by accurately weighing on a balance calibrated by an independent company to standards traceable to international measurement standards. Salimetrics prepares the progesterone high control (1000 pg/mL) via dilution with standard diluent, following GMP regulations. Salimetrics low control is prepared from the Salimetrics progesterone working calibrator (2430 pg/mL) via dilution with standard diluent, following GMP regulations. Pipettes and balances are independently validated to NIST standards. The control performance is verified by immunoassay.

d. Detection limit:

Not applicable

e. Analytical specificity:

Not applicable

f. Assay cut-off:

Not applicable

{4}

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.

5