(10 days)
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No
The summary describes a calibrator for clinical chemistry systems and does not mention any AI or ML components or functionalities.
No
The product is described as an "in vitro diagnostic" for the calibration of clinical chemistry systems, not for treating diseases or conditions.
Yes
This device is an in vitro diagnostic product intended for the quantitative calibration of clinical chemistry systems, which are used for diagnostic measurements.
No
The device is described as an in vitro diagnostic calibrator, which is a physical substance used to calibrate laboratory instruments. The description explicitly mentions "material" and "lot specific calibration set point values," indicating a tangible product, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
The "Intended Use / Indications for Use" section explicitly states: "This product is intended for in vitro diagnostic for the quantitative calibration of automated, semi-automated, or manual clinical chemistry systems for the measurement of ammonia, ethanol and lactate."
This statement clearly indicates that the product is used outside of the body (in vitro) for diagnostic purposes, specifically for calibrating systems that measure substances in clinical samples. This aligns directly with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
This product is intended for in vitro diagnostic for the quantitative calibration of automated, semi-automated, or manual clinical chemistry systems for the measurement of ammonia, ethanol and lactate. Each lot of DOCUMENT" Ammonia, Ethanol, Lactate Calibrator has lot specific calibration set point values for the various analytical systems on which is was assayed. This material is not intended for use on those clinical chemistry systems employing reflectance spectroscopy.
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 circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized emblem featuring three curved shapes that resemble a bird in flight or a stylized human figure. The logo is printed in black and white.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
APR 2 4 1998 Ms. Christine V. Beach Manager, Regulatory Affairs CASCO Standards 500 Riverside Industrial Parkway Portland, Maine 04103-1418
Re : K981436 Trade Name: DOCUMENT Ammonia/Ethanol/Lactate Calibrator for use on BMC Hitachi 717 Analyzer Requlatory Class: II Product Code: JIX Dated: April 9, 1998 Received: April 14,1998
Dear Ms. Beach:
laws or regulations.
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 leqally 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 qeneral controls provisions of the Act. The general controls provisions of the Act include requirements for annual reqistration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst 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 Requlations, 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 Reqister. 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
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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 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
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510(k) Number : K981436
DOCUMENI" Ammonia, Ethanol, Lactate Calibrator Device Name:
Indications for Use:
This product is intended for in vitro diagnostic for the quantitative calibration of automated, semi-automated, or manual clinical chemistry systems for the measurement of ammonia, ethanol and lactate. Each lot of DOCUMENT" Ammonia, Ethanol, Lactate Calibrator has lot specific calibration set point values for the various analytical systems on which is was assayed. This material is not intended for use on those clinical chemistry systems employing reflectance spectroscopy.
(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)
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Over-the -Counter Use
(Optional Format 1-2-96)
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