(33 days)
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No
The summary describes a calibration standard for a laboratory test, not a device that processes data or makes decisions using AI/ML.
No.
The device is intended for verification of calibration of a Parathyroid Hormone test, not for treating or diagnosing any disease or condition.
No
Explanation: This device is a "CalCheck" product used for the periodic verification of the calibration of a test. It does not directly diagnose a condition or disease in a patient.
No
The device description explicitly states it is a "lyophilized product manufactured using a human serum base, synthetic PTH, and preservative," indicating it is a physical reagent, 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 "periodic verification of the calibration of the Elecsys® Parathyroid Hormone test." This test is used to measure parathyroid hormone, which is a substance found in the body. Verifying the calibration of a test that measures a substance in the body is a core function of an IVD.
- Device Description: The description mentions it's a "lyophilized product manufactured using a human serum base, synthetic PTH, and preservative." This indicates it's a reagent or control material used in a laboratory setting to interact with a biological sample (or a simulated biological sample in this case, as it's used for calibration).
- Predicate Device: The mention of a "Predicate Device(s) (K number(s) and name(s); separate multiples with ";") Elecsys CalCheck TSH" further supports its classification as an IVD. Predicate devices are typically other IVDs that the current device is being compared to for regulatory purposes.
While the document doesn't provide details about patient age, user setting, or performance metrics like sensitivity and specificity (which are more relevant to the diagnostic test itself rather than a calibration check), the core function and composition align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Elecsys® Parathyroid Hormone CalCheck is used to verify the calibration of the Elecsys® Parathyroid Hormone assay. Elecsys® Parathyroid Hormone CalCheck calibration verification solutions comprise three levels - low, mid, and high - each with a defined parathyroid hormone concentration. The low solution concentration is near the lower detection limit of the assay. The middle solution is in the middle or at the clinically critical point of the measuring range. The high solution is near the upper limit of the measuring range. The Elecsys® Parathyroid Hormone CalCheck is intended for use in periodic verification of the calibration of the Elecsys® Parathyroid Hormone test.
Product codes (comma separated list FDA assigned to the subject device)
JJX
Device Description
The Elecsys® Parathyroid Hormone CalCheck is a lyophilized product manufactured using a human serum base, synthetic PTH, and preservative. The analyte is appropriately spiked into the CalCheck matrix to the correct CalCheck concentration levels.
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
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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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® Parathyroid Hormone CalCheck was evaluated for value assignment and stability.
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.
The Elecsys® Parathyroid Hormone CalCheck is substantially equivalent to the currently marketed Elecsys CalCheck TSH.
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 | NOV 30 1999 |
|---|---|
| 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 Corporation |
| 9115 Hague Road | |
| Indianapolis, IN 46250 | |
| (317) 576 - 3723 | |
| Contact Person: Priscilla A. Hamill | |
| Date Prepared: October 26, 1999 | |
| Device Name | Proprietary name: Elecsys® Parathyroid Hormone CalCheck |
| Common name: Calibration Verification Material | |
| Classification name: Single (specified) analyte controls (assayed + | |
| unassayed) | |
| Predicate | |
| device | The Elecsys® Parathyroid Hormone CalCheck is substantially equivalent to |
| the currently marketed Elecsys CalCheck TSH. | |
| Device ® | |
| Description | The Elecsys® Parathyroid Hormone CalCheck is a lyophilized product |
| manufactured using a human serum base, synthetic PTH, and preservative. | |
| The analyte is appropriately spiked into the CalCheck matrix to the correct | |
| CalCheck concentration levels. | |
| Intended use | The Elecsys® Parathyroid Hormone CalCheck is used to verify the calibration of the Elecsys® Parathyroid Hormone assay. |
| Comparison to predicate device | The Elecsys® Parathyroid Hormone CalCheck is substantially equivalent to other products in commercial distribution intended for similar use. Most notably, it is substantially equivalent to the currently marketed Elecsys® CalCheck™ TSH. |
Both products are intended to be used for the verification of calibration for analytes on the Elecsys® Immunoassay Analyzers. |
| Performance Characteristics | The Elecsys® Parathyroid Hormone CalCheck was evaluated for value assignment and stability. |
NOV 300 1999
:
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510(k) Summary, Continued
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, in the center. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus. The seal is simple, using a black and white color scheme.
NOV 300 1999
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Priscilla A. Hamill Regulatory Affairs, Laboratory Systems Roche Diagnostics Corporation 9115 Hague Road Indianapolis, Indiana 46250-0457
K993642 Re:
Trade Name: Elecsys® Parathyroid Hormone CalCheck Regulatory Class: I Product Code: JJX Dated: October 26, 1999 Received: October 28, 1999
Dear Ms. Hamill:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS inspections. the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770)488-7655.
This letter will allow you to begin marketing your device as described in your 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 advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll free number (800) 638-2041 or at (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html"
Sincerely yours,
Steven Autman
Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use Statement
510(k) Number (if known): N/A
Device Name: Elecsys® Parathyroid Hormone CalCheck
Indications For Use:
Elecsys® Parathyroid Hormone CalCheck calibration verification solutions comprise three levels - low, mid, and high - each with a defined parathyroid hormone concentration. The low solution concentration is near the lower detection limit of the assay. The middle solution is in the middle or at the clinically critical point of the measuring range. The high solution is near the upper limit of the measuring range.
The Elecsys® Parathyroid Hormone CalCheck is intended for use in periodic verification of the calibration of the Elecsys® Parathyroid Hormone test.
V Prescription Use (Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
Peter E. Madeni
(Division Sign-Off)
Division of Clinical Laboratory Devices K993642
510(k) Number
.