(10 days)
Not Found
No
The device is a control material for immunoassay analyzers and the description focuses on its composition, manufacturing, and performance characteristics as a control. There is no mention of AI or ML in the intended use, device description, or performance studies.
No
This device is an assayed control used for calibration verification and assay range verification for diagnostic tests, not for treating any condition or disease.
No
This device is an assayed control used for calibration verification and verification of assay range for Elecsys LH reagent. It is not used to diagnose a patient's condition directly.
No
The device description explicitly states it is a "lyophilized product consisting of human luteinizing hormone (LH) 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's for "calibration verification and for use in the verification of the assay range established by the Elecsys LH reagent on the indicated Elecsys and cobas e immunoassay analyzers." This indicates it's used in vitro (outside the body) to assess the performance of a diagnostic assay.
- Device Description: It's a "lyophilized product consisting of human luteinizing hormone (LH) in a human serum matrix." This is a biological material designed to be used in a laboratory setting for testing.
- Performance Studies: The performance studies describe testing conducted on immunoassay analyzers, which are used for in vitro diagnostic testing.
- Predicate Device: The predicate device listed is "Elecsys N-MID Osteocalcin CalCheck 5," which is also a control product used in in vitro diagnostic testing.
All these factors point to the device being used in vitro to support the accuracy and reliability of a diagnostic test, which is the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Elecsys LH 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 LH 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 LH CalCheck 5 is a lyophilized product consisting of human luteinizing hormone (LH) in a human serum matrix. During manufacture, the analyte is spiked into the matrix at the desired concentration levels.
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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The Elecsys LH CalCheck 5 was evaluated for value assignment and stability.
Value assignment testing was conducted and must pass pre-defined acceptance criteria. For each Elecsys LH CalCheck 5 lot manufactured, the CalChecks are run in duplicate on at least three E170 analyzer measuring cells. The assigned value of each CalCheck is defined as the median value obtained over at least 6 determinations (duplicate runs on at least 3 analyzer measuring cells) of the respective CalCheck. The target value for each CalCheck is the median value obtained over at least 6 determinations of the respective CalCheck. The assigned range is calculated as +/-30% of the assigned value for levels 2 through 5. The % CV is 10% for levels 2 through 5, while level 1 is free of the analyte. The label states that each laboratory should establish appropriate acceptance criteria when using this product for its intended use.
To ensure the values assigned using the master platform are transferrable and valid for the other instrument platforms, the same value assignment procedure is performed on the Elecsys 2010, cobas e 411, cobas e 601, and cobas e 602 analyzers. The assigned values obtained on the additional analyzers are compared to those obtained on the MODULAR ANALYTICES E170. The median value obtained on the four additional analyzers must be within 10% of the master platform assigned value (10% for between analyzer platform tolerances). After this acceptance criterion is met, the assigned values from the master platform are deemed valid for the MODULAR ANALYTICS E170, Elecsys 2010, cobas e 411, cobas e 601, and cobas e 602 immunoassay analyzers.
Real-time and accelerated stability tests were conducted to establish the shelflife and open-vial claims.
Real-time testing was performed and the data support the package insert claim that reconstituted Elecsys LH CalCheck 5 is stable up to 4 hours at 20-25°C.
The accelerated stability testing performed at 35℃ supports an initial shelflife claim of 18 months at 2-8°C. Real-time testing at 2-8°C is on-going to support a claim of 36 months.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 862.1660 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
121279
510(k) Summary
Introduction
According to the requirements of 21 CFR 807.92, the following information provides sufficient detail to understand the basis for a determination of substantial equivalence.
Submitter name, address, contact
Roche Diagnostics 9115 Hague Road, P.O. Box 50416 Indianapolis, IN 46250-0416 317-521-3501
Contact Person: K. Colleen Adams Phone: 317-521-3577 Fax: 317-521-2324 Email: colleen.adams@roche.com
Secondary Contact: Stephanie Greeman Phone: 317-521-2458 Fax: 317-521-2324 Email: stephanie.greeman@roche.com
Date Prepared: April 27, 2012
Device Name
Proprietary name: Elecsys LH CalCheck 5 Common name: LH CalCheck 5 Classification: 21 CFR 862.1660, Single (specified) analyte controls (assayed and unassayed), Product Code: JJX
Predicate device
commercial distribution intended for similar use. We claim equivalency to the currently marketed Elecsys N-MID Osteocalcin CalCheck 5 (K112104).
The Elecsys LH CalCheck 5 is substantially equivalent to other products in
Device Description
Intended use
The Elecsys LH CalCheck 5 is a lyophilized product consisting of human luteinizing hormone (LH) in a human serum matrix. During manufacture, the analyte is spiked into the matrix at the desired concentration levels.
The Elecsys LH 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 LH reagent on the indicated Elecsys and cobas e immunoassay analyzers.
Continued on next page
1
510(k) Summary, Continued
The table below compares Elecsys LH CalCheck 5 with the predicate devices, Comparison Table Elecsys N-MID Osteocalcin CalCheck 5 (K112104).
| Characteristic | Elecsys LH CalCheck 5
(Candidate) | Elecsys N-MID Osteocalcin
CalCheck 5 (K112104) |
|----------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Differences | | |
| Intended Use | The Elecsys LH 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 Myoglobin
reagent on the indicated Elecsys and
cobas e immunoassay analyzers. | The Elecsys N-MID Osteocalcin
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 N-
MID Osteocalcin reagent on the
indicated Elecsys and cobas e
immunoassay analyzers. |
| Analyte | Luteinizing Hormone (LH) | Osteocalcin |
| Similarities | | |
| Matrix | Human serum matrix | Same |
| Levels | Five | Same |
| Format | Lyophilized | Same |
| Handling | Reconstitute Check 1, Check 2, Check
3, Check 4, and Check 5 with exactly
1.0 mL distilled or deionized water.
Allow to stand closed for 15 minutes,
then mix gently by inversion. | Same |
| Stability | Unopened:
• Store at 2-8°C until expiration date
Opened:
• 20-25°C: 4 hours | Same |
Performance Characteristics
The Elecsys LH CalCheck 5 was evaluated for value assignment and stability. See the following sections for details.
Traceability
The Elecsys LH CalCheck 5 was standardized against the 2nd International Standard (NIBSC) 80/552.
Continued on next page
2
510(k) Summary, Continued
Value Assignment
ジ
Value assignment testing was conducted and must pass pre-defined acceptance criteria. For each Elecsys LH CalCheck 5 lot manufactured, the CalChecks are run in duplicate on at least three E170 analyzer measuring cells. The assigned value of each CalCheck is defined as the median value obtained over at least 6 determinations (duplicate runs on at least 3 analyzer measuring cells) of the respective CalCheck. The target value for each CalCheck is the median value obtained over at least 6 determinations of the respective CalCheck. The assigned range is calculated as ±30% of the assigned value for levels 2 through 5. The % CV is 10% for levels 2 through 5, while level 1 is free of the analyte. The label states that each laboratory should establish appropriate acceptance criteria when using this product for its intended use.
To ensure the values assigned using the master platform are transferrable and valid for the other instrument platforms, the same value assignment procedure is performed on the Elecsys 2010, cobas e 411, cobas e 601, and cobas e 602 analyzers. The assigned values obtained on the additional analyzers are compared to those obtained on the MODULAR ANALYTICES E170. The median value obtained on the four additional analyzers must be within 10% of the master platform assigned value (10% for between analyzer platform tolerances). After this acceptance criterion is met, the assigned values from the master platform are deemed valid for the MODULAR ANALYTICS E170, Elecsys 2010, cobas e 411, cobas e 601, and cobas e 602 immunoassay analyzers.
Stability
Real-time and accelerated stability tests were conducted to establish the shelflife and open-vial claims.
Open-Vial Stability After Reconstitution:
Real-time testing was performed and the data support the package insert claim that reconstituted Elecsys LH CalCheck 5 is stable up to 4 hours at 20-25°C.
Shelf-Life Stability:
The accelerated stability testing performed at 35℃ supports an initial shelflife claim of 18 months at 2-8°C. Real-time testing at 2-8°C is on-going to support a claim of 36 months.
3
10903 New Hampshire Avenue Silver Spring, MD 20993
Roche Diagnostics c/o K. Colleen Adams Roche Professional Diagnostics 9115 Hague Road Indianaopolis, IN 46250-0416
MAY 1 0 2012
K121279 Re:
Trade Name: Elecsys LH CalCheck 5 Regulation Number: 21 CFR §862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: Class I, reserved Product Codes: JJX Dated: April 27, 2012 Received: April 30, 2012
Dear Ms Adams:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
4
Page 2
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, J please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (301) 796-5760. For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/Medical
Devices/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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-5680 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm
Sincerely yours,
$\qquad$
Counney H. Lias, Ph.D. Director Division of Chemistry and Toxicology Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
5
Indication for Use
K121279 510(k) Number (if known):
Device Name: Elecsys LH CalCheck 5
Indication For Use:
The Elecsys LH 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 LH reagent on the indicated Elecsys and cobas e immunoassay analyzers.
Prescription Use X (21 CFR Part 801 Subpart D) And/Or
Over the Counter Use (21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation and Safety (OIVD)
Ruta Chian
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) (2\279