(22 days)
Not Found
Not Found
No
The device is an in vitro diagnostic control material used for calibration verification and assay range verification of an immunoassay analyzer. The description focuses on the composition, traceability, and stability of the control material, with no mention of AI or ML. The performance studies described are standard stability and value assignment procedures for control materials, not performance evaluations of an AI/ML model.
No.
The 'Intended Use' section states it is an 'assayed control for use in calibration verification and for use in the verification of the assay range', indicating it is used for checking the accuracy of diagnostic tests, not for treatment.
No
Explanation: The device is described as an "assayed control for use in calibration verification and for use in the verification of the assay range" of a reagent used on immunoassay analyzers. It is a control material used to assess the performance and calibration of an in vitro diagnostic device, not a diagnostic device itself.
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 for "calibration verification and for use in the verification of the assay range established by the Elecsys Progesterone III reagent on the indicated Elecsys and cobas e immunoassay analyzers." This is a function performed in vitro (outside the body) to ensure the accuracy and reliability of a diagnostic test (the Elecsys Progesterone III reagent).
- Device Description: It is a "lyophilized product consisting of 5 different levels of plant-derived Progesterone in a human serum matrix." This describes a reagent or control material used in laboratory testing.
- Context: The device is used in conjunction with "Elecsys and cobas e immunoassay analyzers," which are instruments used for in vitro diagnostic testing.
- Predicate Device: The mention of a predicate device (K142147; Elecsys Estradiol III CalCheck 5) which is also a CalCheck for an Elecsys assay, further supports its classification as an IVD. CalChecks are a common type of control material used in IVD testing.
While it's not a diagnostic test itself that directly diagnoses a condition, it is a critical component used with a diagnostic test to ensure its proper function and accuracy, making it an IVD device.
N/A
Intended Use / Indications for Use
The Elecsys Progesterone III CalCheck 5 is an assayed control for use in callbration verification and for use in the verification of the assay range established by the Elecsys Progesterone III reagent on the indicated Elecsys and cobas e immunoassay analyzers.
Product codes (comma separated list FDA assigned to the subject device)
JJX
Device Description
The Elecsys Progesterone III CalCheck 5 is a lyophilized product consisting of 5 different levels 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)
Stability Studies
Two studies were performed in order to verify the stability claims for the Progesterone III CalCheck 5. Additionally, a real-time stability study is ongoing to support the shelf-life stability claim.
Opened-vial and accelerated stability studies were completed on the cobas e 411. Because these studies are not analyzer-dependent, these results, in addition to realtime stability study results, can be applied to the MODULAR ANALYTICS E170, cobas e 601 and cobas e 602.
Study 1. Open-Vial Stability:
The on-test and reference materials were tested in duplicate. The on-test material was reconstituted and stored for 5 hours at 25°C (in an open vial). The reference material was a freshly reconstituted set of CalChecks. The on-test recovery was calculated as a percent of the reference value.
One Progesterone III CalCheck 5 lot was evaluated in duplicate on the cobas e 411. The acceptance criterion for CalCheck Level 1 was
§ 862.1660 Quality control material (assayed and unassayed).
(a)
Identification. A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.(b)
Classification. Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are 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 caduceus symbol, which is a staff with two snakes entwined around it. The logo also includes the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular fashion around the caduceus symbol.
May 1, 2015
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
ROCHE DIAGNOSTICS ADAM CLARK REGULATORY AFFAIRS CONSULTANT 9115 HAGUE ROAD INDIANAPOLIS IN 46250
Re: K150955
Trade/Device Name: Elecsys Progesterone III CalCheck 5 Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: I. Reserved Product Code: JJX Dated: April 8, 2015 Received: April 9, 2015
Dear Mr. Clark:
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
Page 2-Mr. Clark
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, Ph.D. 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) K150955
Device Name Elecsys Progesterone III CalCheck 5
Indications for Use (Describe)
The Elecsys Progesterone III CalCheck 5 is an assayed control for use in callbration verification and for use in the verification of the assay range established by the Elecsys Progesterone III reagent on the indicated Elecsys and cobas e immunoassay analyzers.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | □ Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(k) Summary for the Elecsys Progesterone III CalCheck 5
| Introduction | According to the requirements of 21 CFR 807.92, the following information provide
sufficient detail to understand the basis for a determination of substantial
equivalence. | | |
|-------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------|--|
| Submitter
Name,
Address,
Contact | Roche Diagnostics
9115 Hague Road
P.O. Box 50416
Indianapolis, IN 46250-0415
Contact Person: Adam Clark
Phone: (317) 521-4371 Fax: (317) 521-2324 Email: adam.clark@roche.com Secondary Contact Person: Michael Leuther
Phone: (317) 521-3930 Fax: (317) 521-2324 Email: michael.leuther@roche.com Date Prepared: April 27, 2015 | | |
| Purpose | In accordance with 21 CFR 807.87, Roche Diagnostics hereby submits official
notification as required by Section 510(k) of the Federal Food, Drug and Cosmetics
Act of our intention to market the device described in this Premarket Notification
510(k).
The purpose of this premarket notification is to obtain FDA review and clearance for
the Elecsys Progesterone III CalCheck 5. | | |
| Device Name | Proprietary name: | Elecsys Progesterone III CalCheck 5 | |
| | Common name: | Progesterone III CalCheck 5 | |
| | Classification name: | 21 CFR 816.1660, Single (specified) analyte controls (assayed
and unassayed) | |
| | Product Code: | JJX | |
| | Predicate Device: | Elecsys Estradiol III CalCheck 5 | |
4
Establishment For the Elecsys Progesterone III CalCheck 5, the establishment registration number Registration for Roche Diagnostics GmbH in Mannheim, Germany is 9610126, and for Penzberg, Germany is 9610529. The establishment registration number for Roche Diagnostics in the United States is 1823260.
Classification The FDA has classified the Elecsys Progesterone III CalCheck 5 as a Class I reserved device.
| Panel | Product Code | Classification Name | Regulation Citation |
|---|---|---|---|
| Clinical Chemistry (75) | JJX | Single (specified) analyte controls (assayed and unassayed) | 21 CFR 862.1660 |
Device Description Elecsys Progesterone III CalCheck 5:
- The Elecsys Progesterone III CalCheck 5 is a lyophilized product consisting of 5 different levels 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.
5
| Intended Use/
Indications
for Use | The Elecsys Progesterone III CalCheck 5 is an assayed control for use in calibration
verification and for use in the verification of the assay range established by the
Elecsys Progesterone III reagent on the indicated Elecsys and cobas e immunoassay
analyzers. | |
|--------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Substantial
Equivalence | The Elecsys Progesterone III CalCheck 5 is substantially equivalent to other products
in commercial distribution intended for similar use. We claim equivalency to the
currently approved Elecsys Estradiol III CalCheck 5 (K142147). | |
| Substantial
Equivalence -
Comparison | The table below compares Elecsys Progesterone III CalCheck 5 with the predicate
device, Elecsys Estradiol III CalCheck 5 (K142147). | |
| Assay Comparison | | |
| Feature | Predicate Device:
Elecsys Estradiol III CalCheck 5
(K142147) | Candidate Device:
Elecsys Progesterone III CalCheck 5 |
| General Assay Features | | |
| Intended Use/
Indications for
Use | The Elecsys Estradiol III
CalCheck 5 is an assayed control
for use in calibration verification
and for use in the verification of
the assay range established by the
Elecsys Estradiol III reagent on
the indicated Elecsys and cobas e
immunoassay analyzers. | The Elecsys Progesterone III CalCheck 5
is an assayed control for use in
calibration verification and for use in the
verification of the assay range
established by the Elecsys Progesterone
III reagent on the indicated Elecsys and
cobas e immunoassay analyzers. |
| Analyte | Estradiol (Synthetic) | Progesterone (plant material) |
| Matrix | Human serum matrix | Human serum matrix |
| Levels | Five | Five |
| Assay Measuring
Range | 5 - 3000 pg/mL | 0.05 - 60 ng/mL |
| Check Target
Values | Check 1: ≤ 10 pg/mL
Check 2: 100 pg/mL
Check 3: 1500 pg/mL
Check 4: 2400 pg/mL
Check 5: 3000 pg/mL | Check 1: ≤0.15 ng/mL
Check 2: 2.0 ng/mL
Check 3: 30.0 ng/mL
Check 4: 45.0 ng/mL
Check 5: 60.0 ng/mL |
| Format | Lyophilized | Lyophilized |
| Handling | Reconstitute Check 1, Check 2,
Check 3, Check 4, and Check 5
with exactly 1.0mL distilled or
deionized water. Allow to stand
closed for 15 minutes, then mix
gently by inversion to ensure
homogeneity. | Reconstitute Check 1, Check 2, Check 3,
Check 4, and Check 5 with exactly
1.0mL distilled or deionized water.
Allow to stand closed for 15 minutes,
then mix gently by inversion to ensure
homogeneity. |
| Stability | Unopened:
Store at 2-8°C until
expiration dateOpened:
20-25°C: 4 hours | Unopened:
Store at 2-8°C until expiration
dateOpened:
20-25°C: 4 hours |
| Traceability | The Elecsys Progesterone III CalCheck 5 was standardized against ID-GC/MS
(isotope dilution gas chromatography mass spectrometry). | |
| Value
Assignment | Value assignment testing was conducted and passed pre-defined acceptance
criteria. For each Elecsys Progesterone III CalCheck 5 lot manufactured, the
CalChecks are run in duplicate on at least three cobas e 601 analyzers. The assigned
value of each CalCheck is defined as the mean value obtained over at least 6
determinations (duplicate runs on at least 3 analyzers) of the respective CalCheck. | |
| | The CalCheck assigned range is calculated as ±27% of the assigned value
for levels 2 through 5. The label states that each laboratory should establish
appropriate acceptance criteria when using this product for its intended use. | |
| | The same value assignment procedure is performed on the cobas e 411 . The
assigned values obtained are compared to those obtained on the cobas e 601 . The
mean value obtained on the additional analyzer must be within 10% of the master
platform assigned value. After this acceptance criterion is met, the assigned values
from the master platform are deemed valid for the MODULAR ANALYTICS E170,
cobas e 411 , cobas e 601 , and cobas e 602 immunoassay analyzers. | |
| Target Values | The CalCheck target values for the Elecsys Progesterone III Calcheck 5 are as
follows: | |
| | Check Target Values | Check 1: ≤ 0.15 ng/mL |
| | | Check 2: 2.0 ng/mL |
| | | Check 3: 30.0 ng/mL |
| | | Check 4: 45.0 ng/mL |
| | | Check 5: 60.0 ng/mL |
| | Continued on next page | |
6
Comparison of Elecsys Progesterone III CalCheck 5 with the predicate device, Elecsys Estradiol III CalCheck 5 (K142147). Table 1
7
8
Stability Studies
Two studies were performed in order to verify the stability claims for the Progesterone III CalCheck 5. Additionally, a real-time stability study is ongoing to support the shelf-life stability claim.
Opened-vial and accelerated stability studies were completed on the cobas e 411. Because these studies are not analyzer-dependent, these results, in addition to realtime stability study results, can be applied to the MODULAR ANALYTICS E170, cobas e 601 and cobas e 602.
Study 1. Open-Vial Stability:
The on-test and reference materials were tested in duplicate. The on-test material was reconstituted and stored for 5 hours at 25℃ (in an open vial). The reference material was a freshly reconstituted set of CalChecks. The on-test recovery was calculated as a percent of the reference value.
One Progesterone III CalCheck 5 lot was evaluated in duplicate on the cobas e 411. The acceptance criterion for CalCheck Level 1 was