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

Intended 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)

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JUL 1 9 2005

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Eve Schwartz VP of Operations Salimetrics, LLC 101 Innovation Boulevard Suite 302 State College, PA 16803

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k051012 Re:

Trade/Device Name: Salimetrics Progesterone Standard Calibrator and Control Regulation Number: 21 CFR 862.1150 Regulation Name: Calibrator Regulatory Class: Class II Product Code: JIT, JJY Dated: April 13, 2005 Received: April 25, 2005

Dear Ms. Schwartz:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for association to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Carol C. Benem

Carol C. Benson, M.A. Acting Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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### Salimetrics, LLC Progesterone Calibrator

FDA Establishment Registration Number:9045886

## Indications for Use

#### 510 (k) Number: K051012

ട്രാ (1) Name: Progesterone Standard Calibrator, one (1)mL of progesterone in a saliva-like matrix at a concentration of 2430 pg/mL with a non-mercury preservative.

> Progesterone High Control (1000 pg/mL) and Progesterone Low Control (50.6 Progesterone Nigh our a saliva-like matrix with a non-mercury preservative.

### Indications for Use:

The salivary progesterone calibrator is a device intended for medical purposes to use in the The salivaly progesterone callibring and to establish points of reference that are used to Salimothes comp in the measurement of free progesterone in saliva.

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

Over-the-Counter Use (OTC): __________________________________________________________________________________________________________________________________________________ Prescription Use: __ X ____ and/or

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Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

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Office of In Vitro Diagnostic
Device Evaluation and Safety

510(k) K051012