(89 days)
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No
The device description and intended use are focused on calibrators and controls for an immunoassay, which are standard laboratory reagents and do not involve AI/ML. The document explicitly states "Mentions AI, DNN, or ML: Not Found".
No
The device is used for calibration and quality control of an immunoassay, not for directly treating or diagnosing physiological conditions in a patient.
No.
The devices are described as calibrators and controls for an immunoassay, which are used to monitor the performance of a test, not to diagnose a condition directly.
No
The device description explicitly states it is a liquid calibrator and controls in a saliva-like matrix, which are physical substances, not software.
Based on the provided information, yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the devices are for "medical purposes" and are used in the "calibration" and "monitoring the performance" of an "immunoassay in the measurement of free progesterone in saliva." This directly aligns with the definition of an IVD, which are reagents, instruments, and systems intended for use in the diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae. While these specific devices are calibrators and controls, they are essential components used with an immunoassay that measures a substance in a biological sample (saliva) for medical purposes.
- Device Description: The description details the composition of the calibrator and controls, which are reagents in a saliva-like matrix. This further supports their role as components used in an in vitro test.
- Anatomical Site: The anatomical site is listed as "Saliva," which is a biological sample collected from the body for in vitro analysis.
The fact that it doesn't mention image processing, AI, or machine learning is irrelevant to its classification as an IVD. IVDs encompass a wide range of technologies, not just those involving advanced computational methods.
Therefore, the description strongly indicates that these devices are intended to be used in an in vitro diagnostic procedure.
N/A
Intended Use / Indications for Use
The salivary progesterone calibrator is a device intended for medical purposes to use in the Salimetrics immunoassay and to establish points of reference that are used to Salimetrics immunoassay 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.
Product codes
JIT, JJY
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 862.1150 Calibrator.
(a)
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.)(b)
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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird with three curved lines representing its wings or feathers. The bird is positioned to the right of a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in capital letters. The text is arranged around the circumference of the circle.
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
$
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 (240) 276-0484. 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 (800) 638-2041 or (301) 443-6597 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
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE I F NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Division Sign Off
Division Sign-Off
Office of In Vitro Diagnostic
Device Evaluation and Safety
510(k) K051012