(28 days)
Not Found
No
The document describes calibration verification solutions for an immunoassay analyzer and does not mention any AI or ML components or functionalities.
No
This device is for verifying the calibration of immunoassay analyzers, not for treating patients.
No
This device is described as a "calibration verification solution" for use in "verification of the calibration" of a reagent used in immunoassay analyzers. It does not diagnose a condition or disease in a patient.
No
The device description explicitly states that the device comprises "solutions" which are physical materials, not software.
Based on the provided information, yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's "For use in the verification of the calibration established by the Elecsys Prolactin II reagent on Elecsys 1010/2010 and MODULAR ANALYTICS E170 Immunoassay analyzers." This describes a product used in vitro (outside the body) to assess the performance of another diagnostic test (the Elecsys Prolactin II reagent).
- Device Description: The description details solutions with defined Prolactin concentrations used to check the calibration of an immunoassay analyzer. This is a typical function of an IVD calibration verification material.
- Predicate Device: The mention of a predicate device (K970147; Elecsys Prolactin CalCheck) which is also a CalCheck product, strongly suggests that this device falls under the same regulatory classification as an IVD.
Therefore, the purpose and nature of this device align with the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
For use in the verification of the calibration established by the Elecsys Prolactin II reagent on Elecsys 1010/2010 and MODULAR ANALYTICS E170 Immunoassay analyzers.
Product codes (comma separated list FDA assigned to the subject device)
JJX
Device Description
The Elecsys Prolactin II CalCheck calibration verification solutions comprise three levels - low, mid and high - each with a defined Prolactin concentration range. The low solution concentration is near the lower detection limit of the assay. The mid solution is in the middle and the high solution is near the upper limit of the measuring range. Roche Diagnostics has validated that these materials are matrix compatible for use on the Elecsys systems.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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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)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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).
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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.
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510(k) Summary - Elecsys Prolactin II CalCheck
| 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 Rd | |
| Indianapolis IN 46250 | |
| (317) 521-3532 | |
| Contact person: Randy Johnson | |
| Date prepared: October 28, 2005 | |
| Device name | Proprietary name: Roche Diagnostics Elecsys Prolactin II CalCheck |
| Common name: Calibration Verification Material | |
| Classification name: Single (specified) Analyte Controls (Assayed and Unassayed) | |
| Device description | The Elecsys Prolactin II CalCheck calibration verification solutions comprise three levels - low, mid and high - each with a defined Prolactin concentration range. The low solution concentration is near the lower detection limit of the assay. The mid solution is in the middle and the high solution is near the upper limit of the measuring range. Roche Diagnostics has validated that these materials are matrix compatible for use on the Elecsys systems. |
Continued on next page·
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510(k) Summary - Elecsys Prolactin II CalCheck, Continued
| Intended use | For use in the verification of the calibration established by the Elecsys
Prolactin II reagent on Elecsys 1010/2010 and MODULAR ANALYTICS
E170 Immunoassay analyzers. |
|----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Predicate
device | The Elecsys Prolactin II CalCheck is equivalent to other devices legally
marketed in the United States. We claim equivalence to the Elecsys Prolactin
CalCheck (K970147). |
| Device
comparison | The table below illustrates the similarities between the Elecsys Prolactin
CalCheck (K970147) and the Elecsys Prolactin II CalCheck (modified
device). |
| Topic | Elecsys Prolactin CalCheck
(K970147) | Elecsys Prolactin II CalCheck
(Modified Device) |
|---------------|----------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended use | For use in the verification of the
calibration established by the Elecsys
Prolactin reagent on Elecsys® 2010
Immunoassay analyzers. | For use in the verification of the
calibration established by the Elecsys
Prolactin II reagent on Elecsys
1010/2010 and MODULAR
ANALYTICS E170 Immunoassay
analyzers. |
| Matrix | Human serum | Buffered equine serum |
| Storage form | Lyophilized | Same |
| Target values | Low = 500 µIU/mL
Mid = 5,000 µIU/mL
High = 8,000 µIU/mL | Same |
| Traceability | Calibrated against the WHO Standard
84/500 | Same |
| Stability | Unopened:
Up to the printed expiration date on
the bottle labels at 2 - 8°C
Reconstituted:
4 hours at 15 - 25°C | Unopened:
Up to the printed expiration date on
the bottle labels at 2 - 8°C
Reconstituted:
4 hours at 15 - 25°C |
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS) of the United States. The logo features a stylized depiction of an eagle or bird with three wing-like shapes, symbolizing care and protection. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol.
Public Health Service
NOV 2 8 2005
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. Randy Johnson, MT (ASCP) Regulatory Affairs Consultant Roche Diagnostics 9115 Hague Road Indianapolis, IN 46250
K053059 Re:
Trade/Device Name: Elecsys Prolactin II CalCheck Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material (assayed and unassayed) Regulatory Class: Class I Product Code: JJX Dated: October 28, 2005 Received: October 31, 2005
Dear Mr. Johnson:
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); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).
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Page 2 -
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific information about the application of labeling requirements to your device, 11 you atons on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (240) 276-0484. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours,
Alberto Gutierrez, Ph.D.
Alberto Gutierrez, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K053059
Device Name: Elecsys Prolactin II CalCheck
Indications For Use:
For use in the verification of the calibration established by the Elecsys Prolactin II reagent on Elecsys 1010/2010 and MODULAR ANALYTICS E170 Immunoassay analyzers.
Prescription Use XXXX (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) KD53059
Confidential
20