(23 days)
Elecsys PreciControl TS is used for quality control of the Elecsys TSH immunoassay on the Elecsys and cobas e immunoassay analyzers.
The Elecsys PreciControl TS is a lyophilized product consisting of human TSH at a euthyroid level in an equine serum matrix. During manufacture, the analyte is spiked into the matrix at the desired concentration levels. All human material should be considered potentially infectious. All products derived from human blood are prepared exclusively from the blood of donors tested individually and shown to be free from HBsAg and antibodies to HCV and HIV. The testing methods applied were FDA-approved or cleared in compliance with the European Directive 98/79/EC, Annex II, List A.
This document describes the 510(k) submission for the Elecsys PreciControl TS, a quality control material for TSH immunoassays. The studies conducted focus on "Value Assignment," "Stability," and "Reconstitution" of the device.
Here's an analysis of the acceptance criteria and study information provided:
1. Table of Acceptance Criteria and Reported Device Performance
| Study Component | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Value Assignment | (a) Precision, % CV: For TSH target value of 0.2 µIU/mL, % CV ≤ 9. (b) Acceptance range of Assigned Value, [%]: For TSH target value of 0.2 µIU/mL, range 60-140%. (c) Assigned value on Additional vs. Master Platform, %: For TSH target value of 0.2 µIU/mL, range 90-110%. | Conclusion: "Acceptance criteria for all stages of the process were met, supporting the target values and ranges above." Specific numerical results for each criterion are not provided in the summary but are stated to have passed. |
| Stability (Reconstituted: 72 hours at 2-8°C, 5 hours on analyzers) | Recovery: 90-110% of the reference material value. | Table 3: Stability of Reconstituted Lyophilized PreciControl TS (72h at 2-8°C, then 6h at 20-25°C) PC TS Sample: Reference 0.174 µIU/mL, Stressed control 0.168 µIU/mL. % Recovery: 96.6% Conclusion: "The data support the package insert claim that reconstituted PreciControl TS is stable for up to: 72 hours at 2-8°C, 5 h at 20-25°C on the analyzers." (The 5 hours on analyzers claim is implicit from the 6h at 20-25°C in the study description). |
| Stability (Reconstituted: 31 days at -20°C) | Recovery: 90-110% of the reference material value. | Table 4: Stability of Reconstituted Lyophilized on cobas e 411 (32 days at -20°C, then 6h at 20-25°C) PC TS Sample: Reference 0.174 µIU/mL, Stressed control 0.177 µIU/mL. % Recovery: 101.7% Conclusion: "The data support the package insert claim that reconstituted PreciControl TS is stable for up to: 31 days at -20°C." |
| Real-Time Stability (Shelf Life) | Recovery: 90-110% of the unstressed reference value (stored at -20°C). | Table 5: Real-time Stability testing plan for PreciControl TS The table shows % Recovery at various time points (months) for three lots (DR01, DR02, DR03). All reported values are within the 90-110% range. Lot DR01: 6m (106%), 9m (100%), 12m (103%), 16m (99%), 19m (103%), 25m (102%) Lot DR02: 6m (99%), 9m (100%), 12m (103%), 16m (98%), 19m (102%), 25m (102%) Lot DR03: 6m (100%), 9m (99%), 12m (95%), 16m (99%), 19m (101%), 25m (99%) Conclusion: "Data support the current package insert claim of shelf life of 24 months." (Note: Data up to 25 months is provided, supporting the 24-month claim). |
| Reconstitution Time Study | Recovery: 90-110% of the value obtained for the 30-minute reconstituted material. | Table showing Reconstitution Time Study Reference (30 min) TS: 0.174 µIU/mL, On-Test (60 min) TS: 0.174 µIU/mL. % Recovery: 100.0% Conclusion: "The data support the package insert claim that the PreciControl TS is completely reconstituted after 30 minutes." |
2. Sample Size and Data Provenance (Test Set)
- Value Assignment:
- The controls are run in duplicate on at least three (3) MODULAR ANALYTICS E170 measuring cells.
- The assigned value is the median of at least six (6) determinations per control level.
- Data provenance: Not explicitly stated, but assumed to be internal laboratory testing by Roche Diagnostics. It would typically be prospective for a new product's value assignment.
- Stability Studies (Study 1 & 2):
- "The on-test and reference materials were tested in duplicate."
- "The PreciControl TS lot was evaluated in duplicate on the cobas e 411."
- Sample size for "stressed" and "reference" is one lot, with duplicate measurements.
- Data provenance: Internal laboratory testing by Roche Diagnostics, likely prospective for stability validation.
- Real-Time Stability Study (Study 3):
- "Data for the time-points at 6, 12, 16, 19, 25 and 37 months tested in duplicate will be available."
- "Currently, the shelf life claim is 24 months. This is based on real-time stability data of three lots."
- Sample size: Three lots tested in duplicate at various time points.
- Data provenance: Internal laboratory testing by Roche Diagnostics, prospective, ongoing.
- Reconstitution Time Study:
- "PreciControl TS was reconstituted for 30 minutes (reference) and 60 minutes. Samples were evaluated in duplicate on the cobas e 411 analyzer."
- Sample size: One lot used, with duplicate measurements at each time point.
- Data provenance: Internal laboratory testing by Roche Diagnostics, likely prospective.
3. Number of Experts and Qualifications for Ground Truth (Test Set)
This device is a quality control material for an immunoassay. The concept of "experts" and "ground truth" as typically applied to image-based diagnostic devices (e.g., radiologists interpreting images) is not directly applicable here.
- Value Assignment: The ground truth or "target value" for the TSH control material is established against the 2nd IRP WHO Reference Standard 80/558. This is a primary reference standard, not dependent on human expert interpretation.
- Stability and Reconstitution: Ground truth is against an unstressed reference material value or a value obtained under standard reconstitution conditions, measured by the same analytical equipment.
Therefore, no human experts are noted as establishing the ground truth for the performance studies of this quality control device.
4. Adjudication Method (Test Set)
Not applicable for this type of device and study. The measurements are quantitative and compared against established reference values or performance specifications, not subjective interpretations requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This device is a quality control material, not a diagnostic algorithm that assists human readers.
6. Standalone (Algorithm Only) Performance Study
This is a standalone performance study of the quality control material itself (Elecsys PreciControl TS) without human intervention in the result generation or interpretation by the device. The purpose is to characterize the performance of the control material (e.g., its target value, stability) when run on an automated immunoassay analyzer. The performance metrics are analytical (precision, recovery, stability), not diagnostic.
7. Type of Ground Truth Used
- Value Assignment: The ground truth for the analyte (TSH) concentration in the control material is traceable to the 2nd IRP WHO Reference Standard 80/558. This is a recognized international reference standard for TSH, providing a highly accurate and standardized basis for the assigned value.
- Stability and Reconstitution Studies: The ground truth for these studies is typically derived from reference measurements (e.g., freshly prepared material, material stored under optimal conditions, or material reconstituted according to the standard protocol). This involves comparing the "stressed" or "test" material's measurement against an unstressed or reference measurement using the same analytical method.
8. Sample Size for the Training Set
Not applicable. This is a quality control material, not an AI/ML algorithm that requires a "training set" in the conventional sense. The "value assignment" process and stability studies are for characterizing the product itself, not for training a model.
9. How the Ground Truth for the Training Set was Established
Not applicable, as no training set for an AI/ML algorithm is involved.
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MAR 2 7 2014
510(k) Summary
.
| Introduction | According to the requirements of 21 CFR 807.92, the following informationprovides sufficient detail to understand the basis for a determination ofsubstantial equivalence. |
|---|---|
| SubmitterName,Address,Contact | Roche Diagnostics9115 Hague Road, P.O. Box 50416Indianapolis, IN 46250-0416Contact Person: Jane PhillipsPhone: 317-521-3338Fax: 317-521-2324Email: jane.phillips@roche.com |
| Date Prepared: March 12, 2014 |
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| Device Name | Proprietary name: | Elecsys PreciControl TS |
|---|---|---|
| Common name: | Elecsys PreciControl TS | |
| Classification name: | Quality control material (assayed and unassayed) | |
| EstablishmentRegistration | For the Elecsys PreciControl TS, the establishment registration number(Roche Diagnostics GmbH Mannheim) is 9610126. The establishmentregistration number for Roche Diagnostics United States is 1823260. |
Classification The FDA has classified the product as a Class I Reserved device.
| Panel | ProductCode | Classification Name | RegulationCitation |
|---|---|---|---|
| Clinical Chemistry | JJX | Quality control material(assayed and unassayed) | 862.1660 |
| PredicateDevice | The Elecsys PreciControl TS is substantially equivalent to other products incommercial distribution intended for similar use. We claim equivalency tothe currently marketed Elecsys PreciControl TSH (K962573). |
|---|---|
| DeviceDescription | The Elecsys PreciControl TS is a lyophilized product consisting of humanTSH at a euthyroid level in an equine serum matrix. During manufacture, theanalyte is spiked into the matrix at the desired concentration levels. Allhuman material should be considered potentially infectious. All productsderived from human blood are prepared exclusively from the blood of donorstested individually and shown to be free from HBsAg and antibodies to HCVand HIV. The testing methods applied were FDA-approved or cleared incompliance with the European Directive 98/79/EC, Annex II, List A. |
| Intended Use | Elecsys PreciControl TS is used for quality control of the Elecsys TSHimmunoassay on the Elecsys and cobas e immunoassay analyzers. |
| SubstantialEquivalence | The Elecsys PreciControl TS is equivalent to the Elecsys PreciControl TSH(K962573). |
| Continued on next page |
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Table 1 below compares Elecsys PreciControl TS with the predicate device, Comparison PreciControl TSH. Table
| Table 1. Comparison of Candidate and Predicate Device | ||||||
|---|---|---|---|---|---|---|
| -- | -- | -- | -- | -- | -- | ------------------------------------------------------- |
. ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------
.
| Characteristic | Elecsys PreciControl TS(Candidate Device) | Elecsys® PreciControl TSH (K962573) |
|---|---|---|
| IntendedUse | Elecsys PreciControl TS is used forquality control of the Elecsys TSHimmunoassay on the Elecsys andcobas e immunoassay analyzers. | PreciControl TSH is used for qualitycontrol of the Elecsys TSHimmunoassay on the Elecsys andcobas e immunoassay analyzers. |
| Format | Lyophilized material needs to bereconstituted with 2.0 mL of distilledor deionized water. | Liquid (2.0 mL) |
| Analyte | Recombinant human TSH | Same |
| Matrix | Equine serum | Same |
| Levels | One | Same |
| TargetRanges | TSH: ~0.2 $ μIU/mL $ | Same |
| Stability | Lyophilized:• Up until labeled expiration date at2-8°CReconstituted:• -20°C: 31 days (1 month) (freezeonly once)• 2-8° C: 72 hours (3 days)• on the analyzers (20-25°C): up to 5hours | Unopened:• Store at 2-8°C until expiration dateOpened:• Unopened at 2-8°C: Up to the statedexpiration date• Opened at 2-8°C: 12 weeks• on the analyzers (20-25°C): up to 5hours |
Continued on next page
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| Characteristic | Elecsys PreciControl TS(Candidate Device) | Elecsys PreciControl TSH (K962573) |
|---|---|---|
| Handling | Carefully dissolve the contents ofone bottle by adding exactly 2.0 mLof distilled or deionized water andallow to stand closed for 30 minutesto reconstitute. Mix carefully,avoiding foam formation.Transfer aliquots (500µl) of thereconstituted control into emptylabeled snap-cap bottles (ControlSetVials)Attach the supplied labels to theadditional bottles. Store the aliquotsimmediately at -20°C.Discard of aliquot after performingthe control procedure since theyshould be used only once. | The control is supplied ready-for-usein bottle compatible with the system.The control should only be left on theanalyzer during performance ofquality control. After use, close thebottle as soon as possible and store at2-8°C. Because of possibleevaporation effects, not more than 20quality control procedures per bottleshould be performed. |
| Traceability | The Elecsys TSH assay wasstandardized against the 2nd IRPWHO Reference Standard 80/558 | Same |
Table 1. Comparison of Candidate and Predicate Devices, continued
The Elecsys PreciControl TS was evaluated for value assignment, stability, and reconstitution. Characteristics
and the same of the same of the same of the same of the same of the same of the states of the states of the states of the states of the states of the states of the states of
・・・・・・・・・・・・・・・・・・・・・
The data demonstrate that the performance of the Elecsys PreciControl TS is Conclusion substantially equivalent to that of the predicate device, Elecsys® PreciControl TSH.
Performance
. . . . . . . .
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Value Assignment
1. Standardization and traceability
Procedure for Value Assignment
The PreciControl TS is assigned an analyte-specific value with the Elecsys TSH immunoassay. The Elecsys TSH assay was standardized against the 2nd IRP WHO Reference Standard 80/558.
2. Value Assignment
Values are assigned for each lot of PreciControl TS in combination with each assay reagent lot available. The controls are run in duplicate on at least three (3) MODULAR ANALYTICS E170 measuring cells. The assigned value of each control level is defined as the median value obtained over at least six (6) determinations of the respective control level.
Acceptance Criteria for Value assignment, specified in Table 2.
- a. Precision of the control determinations
- b. Percent difference between assigned and target (nominal) values
- c. Analyzer-to-analyzer variability
For additional analyzer platforms, the same value assignment procedure is performed. The assigned values obtained on the additional analyzers are compared to those obtained on the MODULAR ANALYTICS E170 (the master analyzer).
Table 2. Value Assignment Acceptance Criteria for PreciControl TS
| TargetValue[µIU/mL] | (a)Precision,% CV | (b)Acceptance rangeof AssignedValue,[%] | (c)Assigned valueon Additionalvs. MasterPlatform,% | |
|---|---|---|---|---|
| TSH | 0.2 | 9 | 60-140 | 90-110 |
Conclusion: Acceptance criteria for all stages of the process were met, supporting the target values and ranges above.
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Stability Studies
Stability
Studies
Three studies were performed in order to verify the stability claims for the PreciControl TS.
All stability studies were performed on the cobas e 411 analyzer.
Study 1 and 2. Stability after Reconstitution:
Study 1
The on-test and reference materials were tested in duplicate. The on-test material was reconstituted and stored for 73 h at +2℃ to +8℃ and afterwards stored in snap-cap bottles for 6h at +20°C to 25°C. The reference material was lyophilized material stored at +2℃ to +8℃. The on-test recovery was calculated as a percent of the reference value.
The PreciControl TS lot was evaluated in duplicate on the cobas e 411. The acceptance criterion was 90-110% recovery of the reference material value.
| Table 3. Stability of Reconstituted Lyophilized PreciControl TS | ||
|---|---|---|
| ----------------------------------------------------------------- | -- | -- |
| Stability of reconstituted PreciControl TS on cobas e 411 | |||
|---|---|---|---|
| Sample | Reference[µIU/mL] | Stressed control[µIU/mL] | % Recovery |
| PC TS | 0.174 | 0.168 | 96.6 |
Continued on next page
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Stability Studies
Stability Study 2 Studies The on-test and reference materials were tested in duplicate. The on-test material was reconstituted and stored for 32 days at -20°C and afterwards stored in snap-cap bottles for 6h at +20°C to 25°C. The reference material was lyophilized material stored at +2℃ to +8℃. The on-test recovery was calculated as a percent of the reference value.
The PreciControl TS lot was evaluated in duplicate on the cobas e 411. The acceptance criterion was 90-110% recovery of the reference material value.
| Stability of reconstituted Lyophilized on cobas e 411 | |||
|---|---|---|---|
| Sample | Reference[µIU/mL] | Stressed control[µIU/mL] | % Recovery |
| PC TS | 0.174 | 0.177 | 101.7 |
Table 4. Stability of Reconstituted Lyophilized PreciControl TS
Conclusion: The data support the package insert claim that reconstituted PreciControl TS is stable for up to:
31 days at -20°C 72 hours at 2-8°C 5 h at 20-25°C on the analyzers
Continued on next page
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Stability Studies
| Stability | Study 3. Real-Time Stability: | |
|---|---|---|
| Studiescontinued | The real-time stability is being evaluated as follows: | |
| In the on-going real-time stability study, the PreciControl TS test material isstored at +2 to +8°C. The controls are tested at specified intervals over theshelf life of the device up to the planned shelf life plus one month. | ||
| Data for the time-points at 6, 12, 16, 19, 25 and 37 months tested in duplicatewill be available. The average on-test recovery value is calculated as percentrecovery compared to the unstressed reference value (stored at -20°C). | ||
| The acceptance criterion is a recovery of 90-110% of the unstressedreference. | ||
| Currently, the shelf life claim is 24 months. This is based on real-timestability data of three lots. | ||
| The testing will be continued with this stability protocol until data is availableto support a claim of 36 months. | ||
| A |
Conclusion: Data support the current package insert claim of shelf life of 24 months.
| Lot | Level | On-Test as a Percent of Reference, % | ||||||
|---|---|---|---|---|---|---|---|---|
| 6 | 9 | 12 | 16 | 19 | 25 | 37 | ||
| DR01 | TSH | 106 | 100 | 103 | 99 | 103 | 102 | |
| DR02 | TSH | 99 | 100 | 103 | 98 | 102 | 102 | |
| DR03 | TSH | 100 | 99 | 95 | 99 | 101 | 99 |
・・・・・
:
Career States
Table 5. Real-time Stability testing plan for PreciControl TS
Continued on next page
.
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Reconstitution
PreciControl TS was reconstituted for 30 minutes (reference) and 60 Reconstitution minutes. Samples were evaluated in duplicate on the cobas e 411 analyzer. Time Study The average recovery after 60 minutes of reconstitution will be calculated as percent recovery compared to the value obtained at 30 minutes of reconstitution (the reference value).
The acceptance criterion is recovery of 90-110% of the value obtained for the 30 minute reconstituted material.
| Reference result(30 min reconstitution)TS [µIU/mL] | On-Test result(60 minreconstitution)TS [µIU/mL] | % Recovery |
|---|---|---|
| 0.174 | 0.174 | 100.0 |
Conclusion: The data support the package insert claim that the PreciControl TS is completely reconstituted after 30 minutes.
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Image /page/9/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol, with three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 27, 2014
ROCHE DIAGNOSTICS JANE PHILLIPS REGULATORY PROGRAM MANAGER 9115 HAGUE ROAD INDIANAPOLIS IN 46250
Re: K140534
Trade/Device Name: Elecsys PreciControl TS Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: I, Reserved Product Code: JJX Dated: February 27, 2014 Received: March 4, 2014
Dear Ms. Phillips:
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. Iisting 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.
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Page 2-Ms. Phillips
If you desire specific advice for your device on our labeling regulations (2) CFR Parts 801 and 809), please contact the Division of Small Manufacturers, International and Consumer Assistance 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. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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/Safetw/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 Small Manufacturers, International and Consumer Assistance 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,
Courtney H. Lias -S
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
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K140534
Device Name Elecsys PreciControl TS
Indications for Use (Describe)
Elecsys PreciControl TS is used for quality control of the Elecsys TSH immunoassay on the 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)
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)
Yung W. Chan -S
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§ 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.