(13 days)
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No
The summary describes a calibrator for a cholesterol assay, which is a chemical reagent, not a device that would typically incorporate AI/ML. There are no mentions of AI, ML, image processing, or data analysis techniques indicative of AI/ML.
No
The device is a calibrator for laboratory assays, not a treatment device for medical conditions.
No
The device is a calibrator for an assay, not a diagnostic device itself. It is used to ensure the accuracy of a diagnostic assay.
No
The provided text describes a "Calibrator" for a laboratory assay, which is typically a physical substance or material used to standardize measurements. There is no mention of software as the primary component or function of the device.
Yes, based on the provided information, the Raichem LIPID Calibrator is an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use explicitly states it's for the "calibration of the Raichem LDL and HDL Cholesterol Direct assay." Calibration is a crucial step in ensuring the accuracy of in vitro diagnostic tests that measure substances in biological samples (like cholesterol in blood).
- Nature of the Device: A calibrator is a substance with a known concentration of an analyte (in this case, lipids) used to set the scale of a measuring instrument (the assay). This function is inherently tied to the process of performing in vitro diagnostic tests.
While the "Device Description" is not found, the intended use alone strongly indicates its role in an in vitro diagnostic process.
N/A
Intended Use / Indications for Use
The Raichem LIPID Calibrator is intended to be used for the calibration of the Raichem LDL and HDL Cholesterol Direct assay.
Product codes
JIX
Device Description
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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)
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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.
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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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§ 862.1150 Calibrator.
(a)
Identification. A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also § 862.2 in this part.)(b)
Classification. Class II (special controls). The device is 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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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three wing-like shapes, positioned to the right of a circular arrangement of text. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" and is arranged around the top half of the circle.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. Jose A. Montanez Official Correspondent Hemagen Diagnostics, Inc. 9033 Red Branch Road Columbia, Maryland 21045
SEP - 3 2002
Re: K022767 Trade/Device Name: RAICHEM® LIPID Calibrator Regulation Number: 21 CFR § 862.1150 Regulation Name: Calibrator, Multi-Analyte Mixture Regulatory Class: II Product Code: JIX Dated: August 20, 2002 Received: August 21, 2002
Dear Mr. Montanez:
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.
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 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 Part 801); 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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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" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html".
Sincerely yours,
Steven Putman
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
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Page of
| 510(k) Number (if known): | K022767 |
|---|---|
| Device Name: | Raichem Lipid Calibrator |
Indications For Use:
Reagent:
The Raichem LIPID Calibrator is intended to be used for the calibration of the Raichem LDL and HDL Cholesterol Direct assay.
Veronica D. Calvin for Joan Cooper
Division of Clinical Laboratory Device 510(k) Number .
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter-Use
(Optional Format 1-2-96)