(79 days)
No
The device is a set of assayed solutions used for calibrating and verifying the performance of immunochemistry and clinical chemistry systems. There is no mention of AI or ML in the description or intended use.
No
The device is described as containing assayed solutions for in vitro diagnostic use, specifically for calibration and verification of immunochemistry and clinical chemistry systems, not for treating a condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that the solutions are "intended for in vitro diagnostic use."
No
The device description explicitly states it contains "assayed solutions" in a "serum matrix" and is provided in "bottles," indicating it is a physical in vitro diagnostic product, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The document explicitly states the intended use is "in vitro diagnostic use in the quantitative determination of linearity, calibration verification and verification of reportable range on immunochemistry systems and clinical chemistry systems". This directly aligns with the definition of an IVD, which are used to examine specimens taken from the human body to provide information for diagnostic purposes.
- Device Description: The device contains assayed solutions of analytes (T4, T3, TSH, Cortisol) in a serum matrix. These are materials used in vitro (outside the body) to test samples.
- Intended User / Care Setting: The intended use is on "immunochemistry systems and clinical chemistry systems," which are laboratory instruments used for in vitro testing.
The document clearly indicates that this product is designed to be used in a laboratory setting to verify the performance of other diagnostic systems, which is a key function of an IVD.
N/A
Intended Use / Indications for Use
DOCUMENT Thyroid CAL • VER contains assayed solutions for in vitro diagnostic use in the quantitative determination of linearity, calibration and verification of reportable range on immunochemistry systems and clinical chemistry systems for the following analytes: Thyroxine (T4). Triodothyronine (T3), Thyroid Stimulating Hormone (TSH), and Cortisol . This product is not intended for use as a calibration material on instrument systems or as a routine quality control material.
Product codes
JJY
Device Description
DOCUMENT® Thyroid CAL . VER contains assayed solutions of the following analytes: Thyroxine (T4), Triiodothyronine (T3), Thyroid Stimulating Hormone (TSH), and Cortisol in a serum matrix. Multiple levels are provided to establish the linear relationship between theoretical operation and actual performance of each chemistry. DOCUMENT Thyroid CAL . VER contains 6 levels, 1 bottle per level, 5.0 milliliters per bottle.
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)
DOCUMENT® Thyroid CAL • VER consists of 8 levels which cover the reportable range of instrumentation on the market. Targets cover the clinical reference range for the analytes present. This product has a 12-month shelf life at frozen temperatures (-10 to -20℃).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
DOCUMENT® Thyroid CAL•VER™ K992034
Reference Device(s)
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.
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NOV 26 1999
ATTACHMENT 2
510(k) SUMMARY
[Refer to 21 CFR $807.92]
| CASCO-NERL Diagnostics | |
|---|---|
| Submitted by: | 500 Riverside Industrial Parkway |
| Portland, ME 04103-1418 | |
| (207)-878-7550 | |
| Contact Person: | Karen Hickey |
| Date Prepared: | September 7, 1999 |
| Proprietary Name: | DOCUMENT® Thyroid CAL•VER™ |
| Common Name: | Calibration Verification Quality Control Material |
| Classification Name: | Control, Multianalyte Assayed |
| (21 CFR §862.1660) | |
| Predicate Device: | DOCUMENT® Thyroid CAL•VER™ |
| 510(k) #K992034 |
Description of the Device:
DOCUMENT® Thyroid CAL . VER contains assayed solutions of the following analytes: Thyroxine (T4), Triiodothyronine (T3), Thyroid Stimulating Hormone (TSH), and Cortisol in a serum matrix. Multiple levels are provided to establish the linear relationship between theoretical operation and actual performance of each chemistry. DOCUMENT Thyroid CAL . VER contains 6 levels, 1 bottle per level, 5.0 milliliters per bottle.
Intended Use of the Device:
DOCUMENT Thyroid CAL • VER contains assaved solutions for in vitro diagnostic use in the quantitative determination of linearity, calibration and verification of reportable range on immunochemistry systems and clinical chemistry systems for the following analytes: Thyroxine (T4). Triodothyronine (T3), Thyroid Stimulating Hormone (TSH), and Cortisol . This product is not intended for use as a calibration material on instrument systems or as a routine quality control material. ﻪ . . .
Technological Characteristics:
Many inspection agencies require the documentation of periodic linearity, calibration verification of reportable range studies on procedures in the clinical laboratory, DOCUMENI® Thyroid CAL . VER will assist in this process when used as instructed. In addition, d Thyroid CAL . VER will provide valuable assistance when troubleshooting chemistry systems, reagent problems and calibration anomalies.
Performance Characteristics and Data
DOCUMENT® Thyroid CAL • VER consists of 8 levels which cover the reportable range of instrumentation on the market. Targets cover the clinical reference range for the analytes present. This product has a 12-month shelf life at frozen temperatures (-10 to -20℃).
1
Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol is a stylized depiction of a human figure embracing a bird, representing the department's mission to protect and promote the health and well-being of Americans.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
NOV 26 1999
Ms. Karen Hickey Director. Quality Assurance and Regulatory Affairs CASCO®NERL Diagnostics 500 Riverside Industrial Parkway Portland, Maine 04103-1418
Re: K993014
Trade Name: DOCUMENT Thyroid CAL VERTM Regulatory Class: I Product Code: JJY Dated: September 3, 1999 Received: September 8, 1999
Dear Ms. Hickey:
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 QS 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
3
III. INDICTATIONS FOR USE STATEMENT
510(k) Number (if known): K_993014
Device name: DOCUMENT Thyroid CAL•VER™
Indications for Use:
DOCUMENT Thyroid CAL • VER contains assayed solutions intended for in vitro diagnostic use in the quantitative determination of linearity, calibration verification and verification of reportable range on immunochemistry systems and clinical chemistry systems for the following analytes: Thyroxine (T4), Triiodothyronine (T3), Thyroid Stimulating Hormone (TSH), and Cortisol.
Prescription Use (Per 21 CFR 801.109) OR
Over-The-Counter-Use
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Teta E. Mahini
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number. K993014