(28 days)
Not Found
No
The summary describes a calibration set for an immunoassay, focusing on chemical composition, value assignment based on median values from multiple runs, and stability testing. There is no mention of AI or ML algorithms for data analysis, interpretation, or device function.
No
The device is a calibrator used for an immunoassay, not a therapeutic device.
No
This device is a calibrator used to ensure the accuracy of a quantitative assay, rather than directly diagnosing a condition.
No
The device description explicitly states it is a "lyophilized buffer/protein/TBG matrix with added L-thyroxine," which is a physical substance, not software. The performance studies also describe testing of this physical material.
Based on the provided information, 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 T-Uptake assay on the Elecsys and cobas e immunoassay analyzers." Calibration materials for diagnostic assays are considered IVDs as they are essential for ensuring the accuracy and reliability of the diagnostic test results.
- Device Description: It is a "lyophilized buffer/protein/TBG matrix with added L-thyroxine," designed to interact with the Elecsys T-Uptake assay. This composition is consistent with a reagent or calibrator used in an in vitro diagnostic procedure.
- Performance Studies: The document details performance studies related to "value assignment, stability and reconstitution" of the CalSet, which are typical evaluations for IVD components.
- Predicate Device: The mention of a "Predicate Device(s)" with a K number (K961488) and the name "Elecsys T-Uptake CalSet" strongly indicates that this device is being submitted for regulatory clearance as an IVD, likely as a modification or update to a previously cleared device.
The fact that it is a calibrator for a quantitative immunoassay used on diagnostic analyzers firmly places it within the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
T-Uptake CalSet is used for calibrating the quantitative Elecsys T-Uptake assay on the Elecsys and cobas e immunoassay analyzers.
Product codes (comma separated list FDA assigned to the subject device)
JIT
Device Description
Elecsys T-Uptake CalSet: T-Uptake CalSet is a lyophilized buffer/protein/TBG matrix with added L-thyroxine. The Elecsys T-Uptake assay is traceable to a clinically defined human serum panel with a mean TBI (thyroxine-binding index) of 1.
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 T-Uptake CalSet was evaluated for value assignment, stability and reconstitution.
CalSet Value Assignment: Value assignment testing was conducted and passed pre-defined acceptance criteria. The target values for the two levels of the T-Uptake CalSet kit are chosen to obtain the best fit with the Reference Standard Curve. For each Elecsys T-Uptake CalSet lot manufactured, the calibrators are run in duplicate on at least three (3) Elecsys 2010 analyzers and at least three (3) MODULAR ANALYTICS E170 analyzers with all T-Uptake 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 pre-defined acceptance criteria for PreciControl Universal have to be met to release the Assigned Values for T-Uptake CalSet.
Stability Studies: Three studies were performed in order to verify the stability claims for the T-Uptake 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 and reference materials were tested in duplicate. The on-test material was reconstituted and stored in closed vials for 85 days at 2 to 8°C, for 699 days at -15 to -25°C and for 6 hours at 20 to 25°C in open vial. In addition, the stability of the T-Uptake CalSet for one (1) freeze/thaw cycles was evaluated. The on-test signal recovery was calculated as percent of the reference value. The reference material was a freshly reconstituted set of T-Uptake CalSet. T-Uptake CalSet was evaluated in duplicate on the cobas e 411. The acceptance criterion was 95 to 105 % signal recovery of the reference material value.
Study 2. Accelerated Stability: The on-test material was stored lyophilized (as supplied to the user) at 35℃ for 3 weeks. The reference material was a freshly reconstituted set of T-Uptake 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 T-Uptake CalSet lot was evaluated in duplicate on the cobas e 411 analvzer. The acceptance criterion was 95 to 105 % recovery of the reference material value.
Study 3. Real-Time Stability: In addition, real-time stability is being evaluated as follows: In the real-time stability study, the T-Uptake 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 (25 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 T-Uptake Calibrator 1 and 2 is recovery of 95-105 % of the reference value.
Reconstitution Study: Reconstitution time for the lyophilized T-Uptake CalSet was tested. Two sets of T-Uptake CalSet were reconstituted, one for 15 minutes and the other for 30 minutes. Signal recovery after 30 minutes reconstitution was compared to the signal value after 15 minutes. T-Uptake CalSet was evaluated in duplicate on the cobas e 411 analyzer as a reference. The acceptance criterion was 95 to 105 % signal recovery of the reference material value.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Signal recovery (for stability and reconstitution studies) and agreement with acceptance criteria (95-105% signal recovery, or meeting pre-defined acceptance criteria for assigned values).
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.
Elecsys T-Uptake CalSet (K961488)
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 and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a representation of the human form.
December 19, 2014
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
ROCHE DIAGNOSTICS KELLI TURNER REGULATORY AFFAIRS PRINCIPAL 9115 HAGUE ROAD, PO BOX 50416 INDIANAPOLIS IN 46250-0416
Re: K143342
Trade/Device Name: Elecsys T-Uptake CalSet Regulation Number: 21 CFR 862.1150 Regulation Name: Calibrator Regulatory Class: II Product Code: JIT Dated: November 20, 2014 Received: November 21, 2014
Dear Ms. Kelli Turner:
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, 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)
Device Name Elecsys T-Uptake CalSet
Indications for Use (Describe)
T-Uptake CalSet is used for calibrating the quantitative Elecsys T-Uptake assay on the Elecsys and cobas e immunoassay analyzers.
Type of Use (Select one or both, as applicable)
X 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, Elecsys T-Uptake 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.
The purpose of this premarket notification is to obtain FDA review and clearance for the Elecsys T-Uptake CalSet.
| Submitter
name, address,
contact | Roche Diagnostics
9115 Hague Road, P.O. Box 50416
Indianapolis, IN 46250-0416
Contact Person: Kelli Turner
Phone: 317-521-4515
Fax: 317-521-2324
Email: kelli.turner@roche.com
Secondary Contact: Michael Leuther
Phone: 317-521-3930
Fax: 317-521-2324
Email: michael.leuther@roche.com
Date Prepared: December 18, 2014 | |
|----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------|
| Device Name | Proprietary name:
Common name:
Classification:
Product Code: | Elecsys T-Uptake CalSet
T-Uptake CalSet
21 CFR 862.1150, Calibrator, Secondary
JIT |
| Establishment
Registration | For the T-Uptake CalSet, the establishment registration number for
Roche Diagnostics GmbH in Mannheim, Germany, is 9610126 and for
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 | Panel | Product | Classification | Regulation | |
|---|---|---|---|---|---|
| Name | Code | Name | Citation | ||
| Elecsys T- | Clinical | JIT | Calibrator, | 21 CFR 862.1150 | |
| Uptake | Chemistry | Secondary | |||
| CalSet | |||||
| Device | |||||
| Description | Elecsys T-Uptake CalSet: | ||||
| ● | (thyroxine-binding index) of 1. | T-Uptake CalSet is a lyophilized buffer/protein/TBG matrix with | |||
| added L-thyroxine. The Elecsys T-Uptake assay is traceable to a | |||||
| clinically defined human serum panel with a mean TBI | |||||
| Intended use | Elecsys T-Uptake CalSet: | ||||
| ● | T-Uptake CalSet is used for calibrating the quantitative Elecsys T- | ||||
| Uptake assay on the Elecsys and cobas e immunoassay analyzers. | |||||
| Predicate | |||||
| device | device Elecsys T-Uptake CalSet (K961488). | The Elecsys T-Uptake CalSet is substantially equivalent to the predicate | |||
| Substantial | |||||
| Equivalence | |||||
| Comparison | predicate device. | The following tables compare the Elecsys T-Uptake CalSet with the |
5
| Comparison The table below compares Elecsys T-Uptake CalSet with the predicate | |
|---|---|
| Table | device, Elecsys T-Uptake CalSet (K961488). |
The change in the new product was in the format, going from liquid to lyophilized.
| Characteristic | Elecsys T-Uptake CalSet
(Candidate) | Elecsys T-Uptake CalSet
(K961488) |
|----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | T-Uptake CalSet is used for
calibrating the quantitative Elecsys
T-Uptake assay on the Elecsys and
cobas e immunoassay analyzers. | Same. |
| Analyte | L-Thyroxine, syntheticThyroxine
binding globuline (TBG), bovine | Same |
| Matrix | Buffer / protein (bovine serum
albumin) / TBG matrix | Same |
| Levels | Two | Same |
| Target Ranges | Cal 1: 0.5 TBI conc.
Cal 2: 1.3 TBI conc. | Cal 1: Same.
Cal 2: Same. |
| Format | Lyophilized | Liquid, ready-for-use. |
| Stability | Unopened:
• Store at 2-8°C until expiration
date
Opened:
• 2-8°C: 84 days
• -20°C: 84 days (freeze only
once)
Elecsys 2010 and cobas e 411
analyzers at 20-25°C:
• up to 5 hours
MODULAR ANALYTICS E170,
cobas e 601 and cobas e 602:
• use only once | Unopened:
• Store at 2-8°C until expiration
date
Opened:
• 2-8°C: 24 hours
• 20-25°C: use only once
• -20°C: 3 month |
| Table continued | | |
| Characteristic | Elecsys T-Uptake CalSet
(Candidate) | Elecsys T-Uptake CalSet
(K961488) |
| 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 the reconstituted calibrators
into the supplied empty labeled snap-
cap bottles.
Elecsys 2010 and cobas e 411
analyzers: The calibrators should only
be left on the analyzers during
calibration at 20-25 °C. After use,
close the
bottles as soon as possible and store
upright at 2-8 °C.
Due to possible evaporation effects,
not more than 5 calibration procedures
per bottle set should be performed.
If necessary, freeze in aliquots; see
section on
MODULAR ANALYTICS E170,
cobas e 601 and cobas e 602
analyzers.
MODULAR ANALYTICS E170,
cobas e 601 and cobas e 602
analyzers:
Unless the entire volume is necessary
for calibration on the analyzers,
transfer aliquots of the reconstituted
calibrators into empty snap-cap bottles
(CalSet Vials). Attach the supplied
labels to these additional bottles. Store
the aliquots at 2-8 °C or -20 °C for
later use.
Perform only one calibration
procedure per aliquot.. | The calibrators are supplied ready
for use in bottles compatible with
the system.
Elecsys 2010 and cobas e 411
analyzers: The calibrators should
only be left on the analyzers
during calibration at 20-25°C.
After use, close the bottles as soon
as possible and store at 2-8°C.
Due to possible evaporation
effects, not more than 5 calibration
procedures per bottle set should be
performed.
MODULAR ANALYTICS E170,
cobas e 601, cobas e 602
analyzers: Unless the entire
volume is necessary for calibration
on the analyzers, transfer aliquots
of the ready for use calibrators into
empty snap-cap bottles (CalSet
Vials). Attach the supplied labels
to these additional bottles. Store
the aliquots at 2-8°C for later use.
Perform only one calibration
procedure per aliquot. |
| Traceability | Standardized using a clinically
defined human serum panel with a
mean TBI of 1.0 | Same |
| Traceability | The T-Uptake CalSet has been standardized against a clinically defined
human serum panel with a mean TBI of 1. | |
| Evaluations
Summary | The Elecsys T-Uptake CalSet was evaluated for value assignment,
stability and reconstitution. | |
| CalSet Value
Assignment | Value assignment testing was conducted and passed pre-defined
acceptance criteria. The target values for the two levels of the T-Uptake
CalSet kit are chosen to obtain the best fit with the Reference Standard
Curve. For each Elecsys T-Uptake CalSet lot manufactured, the
calibrators are run in duplicate on at least three (3) Elecsys 2010 analyzers
and at least three (3) MODULAR ANALYTICS E170 analyzers with all
T-Uptake 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 pre-defined acceptance criteria
for PreciControl Universal have to be met to release the Assigned Values
for T-Uptake CalSet. | |
| | Continued on next page | |
Comparison Table
6
Table continued
7
8
Three studies were performed in order to verify the stability claims for Stability Studies the T-Uptake 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 and reference materials were tested in duplicate. The on-test material was reconstituted and stored in closed vials for 85 days at 2 to 8°C, for 699 days at -15 to -25°C and for 6 hours at 20 to 25°C in open vial. In addition, the stability of the T-Uptake CalSet for one (1) freeze/thaw cycles was evaluated.
The on-test signal recovery was calculated as percent of the reference value. The reference material was a freshly reconstituted set of T-Uptake CalSet.
T-Uptake CalSet was evaluated in duplicate on the cobas e 411. The acceptance criterion was 95 to 105 % signal recovery of the reference material value.
Study 2. Accelerated Stability:
The on-test material was stored lyophilized (as supplied to the user) at 35℃ for 3 weeks. The reference material was a freshly reconstituted set of T-Uptake 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 T-Uptake CalSet lot was evaluated in duplicate on the cobas e 411 analvzer.
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 real-time stability study, the T-Uptake 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 (25 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 T-Uptake Calibrator 1 and 2 is recovery of
95-105 % of the reference value. |
| Reconstitution
Study | Reconstitution time for the lyophilized T-Uptake CalSet was tested. Two
sets of T-Uptake CalSet were reconstituted, one for 15 minutes and the
other for 30 minutes. Signal recovery after 30 minutes reconstitution was
compared to the signal value after 15 minutes. |
| | T-Uptake CalSet was evaluated in duplicate on the cobas e 411 analyzer
as a reference. |
| | The acceptance criterion was 95 to 105 % signal recovery of the reference
material value. |
| | |
| Conclusion | We trust that the data and information provided in this Premarket
Notification (510(k)) will support a determination of substantial
equivalence for the Elecsys T-Uptake CalSet. The data supports a safe
effective device which performs as well as or better than the predicate
device. |