(4 days)
Not Found
No
The summary describes a calibration set for an immunoassay, which is a chemical reagent used to calibrate a laboratory instrument. There is no mention of software, algorithms, or any technology that would suggest the use of AI or ML. The device description is purely about the chemical composition and function of the calibration material.
No.
This device is a calibrator for an immunoassay, used to ensure the accuracy of a diagnostic test, not to treat a medical condition.
No
The device is a CalSet, which is used for calibrating an assay, not for diagnosing a condition or disease directly.
No
The device description clearly states it consists of a lyophilized buffered equine serum matrix with added recombinant prolactin, which are physical components, not software.
Based on the provided information, the Elecsys Prolactin II CalSet is an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use explicitly states it is used for "calibrating the quantitative Elecsys Prolactin II assay". Calibration materials for in vitro diagnostic tests are themselves considered IVDs.
- Device Description: It is a "lyophilized buffered equine serum matrix with added recombinant prolactin". This describes a reagent or material used in a laboratory setting for diagnostic purposes.
- Predicate Device: The mention of a predicate device (K964748; Elecsys Prolactin CalSet) strongly indicates that this device is also an IVD, as predicate devices are used for comparison in regulatory submissions for new IVDs.
While the document doesn't provide details about patient age, anatomical site, or performance studies (which are often included for IVDs that directly analyze patient samples), the core function of calibrating an IVD assay places this device squarely within the definition of an IVD.
N/A
Intended Use / Indications for Use
Elecsys Prolactin II CalSet is used for calibrating the quantitative Elecsys Prolactin II assay on the Elecsys immunoassay systems.
Product codes (comma separated list FDA assigned to the subject device)
JIT
Device Description
The cobas Elecsys® Prolactin II CalSet consists of a lyophilized buffered equine serum matrix with added recombinant prolactin in two concentration ranges. The CalSet can be used with all reagent lots.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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.
Not Found
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).
Not Found
§ 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.
0
510(k) Summary - cobas Elecsys® Prolactin II CalSet
Introduction | According to the requirements of 21 CFR 807.92, the following information provides sufficient detail to understand the basis for a determination of substantial equivalence |
---|---|
Submitter | |
name, address, | |
contact | Roche Diagnostics |
9115 Hague Rd | |
Indianapolis IN 46250 | |
(317) 521-3532 |
Contact person: Randy Johnson
Date prepared: October 21, 2005 |
| Device Name | Proprietary name: Roche Diagnostics cobas Elecsys® Prolactin II CalSet
Common name: Prolactin II CalSet
Classification name: Calibrator, Secondary |
| Device
description | The cobas Elecsys® Prolactin II CalSet consists of a lyophilized buffered equine serum matrix with added recombinant prolactin in two concentration ranges. The CalSet can be used with all reagent lots. |
1
510(k) Summary - cobas Elecsys® Prolactin II CalSet, continued
| Intended use | Elecsys Prolactin II CalSet is used for calibrating the quantitative Elecsys
Prolactin II assay on the Elecsys immunoassay systems. |
|----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Predicate
Device | The cobas Elecsys® Prolactin II CalSet is equivalent to other devices legally
marketed in the United States. We claim equivalence to the Elecsys Prolactin
CalSet (K964748). |
| Device
Comparison | The table below illustrates the similarities between the Elecsys Prolactin
(K964748) and the cobas Elecsys Prolactin II CalSet (modified device). |
| Topic | Elecsys® Prolactin
(K964748) | cobas Elecsys® Prolactin II CalSet
(Modified Device) |
|-----------------|----------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------|
| Intended use | Elecsys Prolactin CalSet is used for
calibrating the quantitative Elecsys
Prolactin assay on the Elecsys
immunoassay systems. | Elecsys Prolactin II CalSet is used for
calibrating the quantitative Elecsys
Prolactin II assay on the Elecsys
immunoassay systems. |
| Matrix | Buffer/protein | Buffered equine serum |
| Storage form | Liquid | Lyophilized |
| Levels | Low: approx. 2 µIU/mL
High: approx. 2,000 µIU/mL | Same |
| Standardization | Standardized using the 3rd IRP WHO
Reference Standard 84/500 | Same |
| Stability | Unopened:
at 2-8°C up to the expiration date. | Unopened:
at 2-8°C up to the expiration date. |
| | Opened:
at 2 - 8°C; 8 weeks
on the analyzers, up to 5 hours in total | Opened:
at -20°C; 3 months (freeze only once)
on the analyzers at 20 - 25°C; use only
once |
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The logo is black and white.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
OCT 2 8 2005
Randy Johnson MT (ASCP) Regulatory Affairs Consultant Roche Diagnostics 9115 Hague Road PO Box 50416 Indianapolis, IN 46250
Re: K052982
Trade/Device Name: cobas Elecsys Prolactin II CalSet Regulation Number: 21 CFR 862.1150 Regulation Name: Calibrator Regulatory Class: Class II Product Code: JIT Dated: October 21, 2005 Received: October 24, 2005
Dear Mr. Johnson:
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 commerce prior 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 (sec 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).
3
Page 2 --
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,
Alberto Gutierrez
Alberto Guticarez, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known):
Device Name: cobas Elecsys Prolactin II CalSet
Indications For Use:
Elecsys Prolactin II CalSet is used for calibrating the quantitative Elecsys Prolactin II assay on the Elecsys immunoassay systems.
Prescription Use XXXX (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Harry Phillips
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
Confidential
510(k) KD52982
20