(29 days)
Not Found
No
The document describes a calibration set for an immunoassay analyzer. The description focuses on the chemical composition, traceability, and stability testing of the calibrator. There is no mention of AI or ML in the intended use, device description, or performance studies. The value assignment process is based on median values from multiple runs, which is a standard statistical method, not AI/ML.
No
This device is a calibrator used to ensure the accuracy of an immunoassay for progesterone, not to treat a medical condition.
No
Explanation: The device is a "CalSet" (calibration set) used to calibrate an assay, not to diagnose a condition itself. Its purpose is to ensure the accuracy of a diagnostic assay by providing known concentrations of the analyte.
No
The device is a lyophilized product consisting of plant-derived progesterone in a human serum matrix, which is a physical substance, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it is used for "calibrating the quantitative Elecsys Progesterone III assay on the Elecsys and cobas e immunoassay analyzers." Calibration is a crucial step in ensuring the accuracy of an in vitro diagnostic test.
- Device Description: The description mentions it's a "lyophilized product consisting of plant-derived progesterone in a human serum matrix." This indicates it's a reagent or material used in a laboratory setting to interact with a biological sample (human serum matrix) for diagnostic purposes.
- Performance Studies: The document details performance studies related to "Value assignment testing" and "Stability studies." These are typical evaluations performed on IVD devices to ensure their reliability and accuracy over time.
- Predicate Device: The mention of a "Predicate Device(s)" with a K number (K964841) is a strong indicator that this device is being submitted for regulatory review as an IVD, as predicate devices are used for comparison in the regulatory process for new IVDs.
While the document doesn't explicitly state "In Vitro Diagnostic," the combination of its intended use, composition, performance evaluation, and regulatory context (implied by the predicate device) clearly identifies it as a device used outside the body to examine specimens for diagnostic purposes, which is the definition of an IVD.
N/A
Intended Use / Indications for Use
Progesterone III CalSet is used for calibrating the quantitative Elecsys Progesterone III assay on the Elecsys and cobas e immunoassay analyzers.
Product codes (comma separated list FDA assigned to the subject device)
JIT
Device Description
The Elecsys Progesterone III CalSet is a lyophilized product consisting of plant-derived progesterone in a human serum matrix. It is traceable via ID-GC/MS (isotope dilution gas chromatography/mass spectrometry) to highly purified progesterone by weight analogous to BCR-348R and ERM-DA347.
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)
Evaluations Summary: The Elecsys Progesterone III CalSet was evaluated for value assignment, reconstitution and stability.
CalSet Value Assignment: Value assignment testing was conducted and passed pre-defined acceptance criteria. The target values for the two levels of the Progesterone III CalSet kit are chosen to obtain the best fit with the Master Calibration Curve, together with the Rodbard curve parameters encoded in the reagent barcode. For each Elecsys Progesterone III CalSet lot manufactured, the calibrators are run in duplicate on at least three (3) cobas e 411 analyzers and at least three (3) cobas e 601/MODULAR ANALYTICS E170 analyzers with all Progesterone III reagent lots available. The assigned value of each calibrator is defined as the median value obtained over at least six (6) runs on at least three (3) analyzers) of the respective calibrator. Measurement values for PreciControl Universal (Level 1 & 2) are read off from the calibration curves generated. The PreciControl Universal is a multi-analyte control recommended for use with specified analytes. The controls are used for monitoring accuracy and precision of the specified assays. The pre-defined acceptance criteria for PreciControl Universal have to be met to release the Assigned Values for Progesterone III CalSet.
Stability Studies: Three studies were performed in order to verify the stability claims for the Progesterone III CalSet. Stability studies after reconstitution and an accelerated stability study were completed on the cobas e 411. Additionally, a real-time stability study is planned.
Study 1. Stability at 2-8°C, -20°C, in open vial and freeze/thaw cycles (after reconstitution):
The on-test materials were reconstituted and stored closed for 25 hours at 2 to 8°C, and for 32 days at -20°C and for 3 hours at 20 to 25°C in open vial prior to testing. In addition, the stability of the Progesterone III CalSet for two (2) freeze/thaw cycles was evaluated.
The on-test and reference materials were tested in duplicate and the recovery was calculated as percent of the reference value.
The acceptance criterion was 95 to 105 % signal recovery of the reference material value. The reference material was a freshly reconstituted set of Progesterone III CalSet.
Study 2. Accelerated Stability:
The on-test material was stored lyophilized (as supplied to the user) at 35°C for 3 weeks. The reference material was a freshly reconstituted set of Progesterone III CalSet (stored at 2 to 8°C). After 3 weeks, the on-test and reference materials were tested in duplicate. The on-test recovery was calculated as a percent of the reference value. One Progesterone III CalSet lot was evaluated in duplicate.
The acceptance criterion was 95 to 105 % recovery of the reference material value.
Study 3. Real-Time Stability:
In the on-going real-time stability study, the Progesterone III CalSet test material is stored at 2-8°C. The CalSets are tested in duplicate at specified intervals over the shelf life of the device up to the planned shelf life plus one month (19 months).
Real-time stability is calculated based on the recovery of signal of stressed calibrator (stored at 2-8°C) vs. unstressed calibrator (stored at -20°C). At the specified intervals over the shelf life, the mean value of the stressed calibrator was calculated as percent recovery of the unstressed value (each tested in duplicates at the same time point).
The acceptance criterion for Progesterone III Calibrator 1 and 2 is recovery of 95-105 % of the reference value.
The testing will continue with this stability protocol until data to support a claim of 18 months is achieved.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Acceptance criterion for stability studies: 95 to 105 % signal recovery of the reference material value.
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized graphic of three human profiles facing right, stacked on top of each other. The profiles are rendered in a dark color, creating a silhouette effect. The graphic is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
October 2, 2015
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
ROCHE DIAGNOSTICS PATTY BATES REGULATORY AFFAIRS PRINCIPAL 9115 HAGUE ROAD INDIANAPOLIS IN 46250
Re: K152526
Trade/Device Name: Elecsvs Progesterone III Calset Regulation Number: 21 CFR 862.1150 Regulation Name: Calibrator Regulatory Class: II Product Code: JIT Dated: September 2, 2015 Received: September 3, 2015
Dear Ms. Bates:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21. Parts 800 to 898. 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
If you desire specific advice for your device on our labeling regulations (21 CFR Parts 801 and 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Katherine Serrano -S
For: Courtney H. Lias Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K152526
Device Name Elecsys Progesterone III CalSet
Indications for Use (Describe)
Progesterone III CalSet is used for calibrating the quantitative Elecsys Progesterone III assay on the Elecsys and cobas e immunoassay analyzers.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
See PRA Statement below.
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
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3
510(k) Summary, Elecsys Progesterone III 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 Information | Roche Diagnostics Corporation
9115 Hague Road, P.O. Box 50416
Indianapolis, IN 46250-0416
Contact Person: Patty Bates, BS, MT (ASCP)
Phone: 317-521-4572
Fax: 317-521-2324
Email: patty.bates@roche.com
Secondary Contact Person: Adam Clark, MBA
Phone: 317-521-4371
Fax: 317-521-2324
Email: adam.clark@roche.com
Date Prepared: September 2, 2015 |
|----------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | |
| | Proprietary name: Elecsys Progesterone III CalSet |
| | Common name: Progesterone III CalSet |
| | Classification: 21 CFR 862.1150, Calibrator, Secondary |
| | Product Code: JIT |
Establishment For the Progesterone III CalSet, the establishment registration number for Roche Diagnostics GmbH in Mannheim, Germany, is 9610126 and for Registration Penzberg, Germany, is 9610529. The establishment registration number for Roche Diagnostics United States is 1823260.
4
Classification FDA has classified the product as a Class II device.
| Product
Name | Panel | Product
Code | Classification
Name | Regulation
Citation |
|----------------------------|-----------------------|-----------------|--------------------------|------------------------|
| Progesterone
III CalSet | Clinical
Chemistry | JIT | Calibrator,
Secondary | 21 CFR 862.1150 |
5
| Device
Description | Elecsys Progesterone III CalSet:
• The Elecsys Progesterone III CalSet is a lyophilized product consisting of
plant-derived progesterone in a human serum matrix. It is traceable via
ID-GC/MS (isotope dilution gas chromatography/mass spectrometry) to
highly purified progesterone by weight analogous to BCR-348R and
ERM-DA347. |
|------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended use | Elecsys Progesterone III CalSet:
• The Progesterone III CalSet is used for calibrating the quantitative
Elecsys Progesterone III assay on the Elecsys and cobas e immunoassay
analyzers. |
| Predicate
device | The Elecsys Progesterone III CalSet is substantially equivalent to the
predicate device, Elecsys Progesterone II CalSet (K964841). |
| Substantial
Equivalence
Comparison | The following table compare the Elecsys Progesterone III CalSet with the
predicate device. |
6
The table below compares Elecsys Progesterone III CalSet with the predicate Comparison device, Elecsys Progesterone II CalSet (K964841). Table
The change in the new product is the addition of calibrator stability at -20°C.
Table
| Characteristic | Elecsys Progesterone III
CalSet
(Candidate) | Elecsys Progesterone II
CalSet
(Predicate) (K964841) |
|----------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Progesterone III CalSet is used
for calibrating the quantitative
Elecsys Progesterone III assay
on the Elecsys and cobas e
immunoassay analyzers. | Progesterone II CalSet is used
for calibrating the quantitative
Elecsys Progesterone assay on
the Elecsys and cobas e
immunoassay analyzers. |
| Analyte | Progesterone (plant-derived) | Same |
| Matrix | Human serum matrix | Same |
| Levels | Two | Same |
| Target Values | Cal 1: 0.080 ng/mL
Cal 2: 53 ng/mL | Same |
| Format | Lyophilized | Same |
| Handling | Carefully dissolve the contents
of one bottle by adding exactly
1.0 mL of distilled or deionized
water and allow to stand closed
for 15 minutes to reconstitute.
Mix carefully, avoiding the
foam formation.
Transfer aliquots of the
reconstituted calibrators into
empty labeled snap-cap bottles
(CalSet Vials). Attach the
supplied labels to the additional
bottles. Store the aliquots
immediately at -20°C.
Perform only one calibration
procedure per aliquot. | Carefully dissolve the contents
of one bottle by adding exactly
1.0 mL of distilled or deionized
water and allow to stand closed
for 15 minutes to reconstitute.
Mix carefully, avoiding the
foam formation.
Transfer aliquots of the
reconstituted calibrators into
empty labeled snap-cap bottles
(CalSet Vials). Attach the
supplied labels to the additional
bottles. Store the aliquots at
2-8°C for later use.
Perform only one calibration
procedure per aliquot. |
7
| Table continued | ||
|---|---|---|
| Characteristic | Elecsys Progesterone III | |
| CalSet | ||
| (Candidate) | Elecsys Progesterone II | |
| CalSet | ||
| (Predicate) (K9648441) | ||
| Stability | Unopened: | |
| • Store at 2-8°C until expiration date | ||
| Opened: | ||
| • 2-8°C: 24 hours | ||
| • 20-25°C on the analyzer: use only once | ||
| • -20°C: 31 days (freeze only once) | Unopened: | |
| • Store at 2-8°C until expiration date | ||
| Opened: | ||
| • 2-8°C: 12 weeks | ||
| • 20-25°C on the analyzer: use only once |
Table continued
| Traceability | The Elecsys Progesterone III CalSet is traceable via ID-GC/MS (isotope dilution gas chromatography/mass spectrometry) to highly purified progesterone by weight analogous to BCR-348R and ERM-DA347. |
|---|---|
| Evaluations Summary | The Elecsys Progesterone III CalSet was evaluated for value assignment, reconstitution and stability. |
| CalSet Value Assignment | Value assignment testing was conducted and passed pre-defined acceptance criteria. The target values for the two levels of the Progesterone III CalSet kit are chosen to obtain the best fit with the Master Calibration Curve, together with the Rodbard curve parameters encoded in the reagent barcode. For each Elecsys Progesterone III CalSet lot manufactured, the calibrators are run in duplicate on at least three (3) cobas e 411 analyzers and at least three (3) cobas e 601/MODULAR ANALYTICS E170 analyzers with all Progesterone III reagent lots available. The assigned value of each calibrator is defined as the median value obtained over at least six (6) runs on at least three (3) analyzers) of the respective calibrator. |
Measurement values for PreciControl Universal (Level 1 & 2) are read off from the calibration curves generated. The PreciControl Universal is a multi-analyte control recommended for use with specified analytes. The controls are used for monitoring accuracy and precision of the specified assays. The pre-defined acceptance criteria for PreciControl Universal have to be met to release the Assigned Values for Progesterone III CalSet.
8
Stability Three studies were performed in order to verify the stability claims for the Studies Progesterone III CalSet. Stability studies after reconstitution and an accelerated stability study were completed on the cobas e 411. Additionally, a real-time stability study is planned.
Study 1. Stability at 2-8°C, -20°C, in open vial and freeze/thaw cycles (after reconstitution):
The on-test materials were reconstituted and stored closed for 25 hours at 2 to 8°C, and for 32 days at -20°C and for 3 hours at 20 to 25°C in open vial prior to testing. In addition, the stability of the Progesterone III CalSet for two (2) freeze/thaw cvcles was evaluated.
The on-test and reference materials were tested in duplicate and the recovery was calculated as percent of the reference value.
The acceptance criterion was 95 to 105 % signal recovery of the reference material value. The reference material was a freshly reconstituted set of Progesterone III CalSet.
Study 2. Accelerated Stability:
The on-test material was stored lyophilized (as supplied to the user) at 35°C for 3 weeks. The reference material was a freshly reconstituted set of Progesterone III CalSet (stored at 2 to 8°C). After 3 weeks, the on-test and reference materials were tested in duplicate. The on-test recovery was calculated as a percent of the reference value. One Progesterone III CalSet lot was evaluated in duplicate.
The acceptance criterion was 95 to 105 % recovery of the reference material value.
9
| Stability Studies, continued | Study 3. Real-Time Stability: In addition, real-time stability is being evaluated as follows: In the on-going real-time stability study, the Progesterone III CalSet test material is stored at 2-8°C. The CalSets are tested in duplicate at specified intervals over the shelf life of the device up to the planned shelf life plus one month (19 months). Real-time stability is calculated based on the recovery of signal of stressed calibrator (stored at 2-8°C) vs. unstressed calibrator (stored at -20°C). At the specified intervals over the shelf life, the mean value of the stressed calibrator was calculated as percent recovery of the unstressed value (each tested in duplicates at the same time point). The acceptance criterion for Progesterone III Calibrator 1 and 2 is recovery of 95-105 % of the reference value. The testing will continue with this stability protocol until data to support a claim of 18 months is achieved. |
|---|---|
| ------------------------------ | --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
| Conclusion | We trust that the information provided in this Premarket Notification (510(k)) will support a determination of substantial equivalence for the Elecsys Progesterone III CalSet. |
|---|---|
| ------------ | --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |