(46 days)
To determine the predicate device(s) for K030045, further information beyond the provided text is needed. The document states "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..." and refers to a "legally marketed predicate device," but it does not explicitly list the K/DEN number of the predicate device(s) within the provided text.
None
No
The summary describes a reagent for a standard clinical chemistry test and contains no mention of AI, ML, or related concepts.
No.
Yes
Explanation: The device is a reagent for determining cholinesterase concentrations in human serum and plasma, which is explicitly stated to "assess liver function," "investigate variants of cholinesterase enzyme," "predict susceptibility to prolonged apnea," and "monitor excessive exposure to organophosphorus insecticides." These are all diagnostic purposes.
No
The device is a reagent for a clinical chemistry analyzer, which is a physical substance used in a laboratory test, not a software-only device.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's a "Reagent for the determination of cholinesterase concentrations in human serum and plasma." This indicates it's used to analyze a sample taken from the human body (in vitro) to provide information about a person's health status.
- Clinical Significance: The intended use also describes the clinical significance of measuring cholinesterase, linking it to assessing liver function, investigating enzyme variants, predicting succinylcholine susceptibility, and monitoring insecticide exposure. These are all diagnostic purposes.
- Sample Type: The device is designed to work with "human serum and plasma," which are biological samples taken from a patient.
Therefore, based on the provided information, this device clearly fits the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Reagent for the determination of cholinesterase concentrations in human serum and plasma using the Olympus family of clinical chemistry analyzers. Measurement of serum cholinesterase has been used to assess liver function and to investigate the variants of cholinesterase enzyme. It is also useful in predicting susceptibility to prolonged apnea after the administration of succinylcholine and in monitoring excessive exposure to organophosphorus insecticides.
Product codes
DIH
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)
To determine the predicate device(s) for K030045, further information beyond the provided text is needed. The document states "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..." and refers to a "legally marketed predicate device," but it does not explicitly list the K/DEN number of the predicate device(s) within the provided text.
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 862.3240 Cholinesterase test system.
(a)
Identification. A cholinesterase test system is a device intended to measure cholinesterase (an enzyme that catalyzes the hydrolysis of acetylcholine to choline) in human specimens. There are two principal types of cholinesterase in human tissues. True cholinesterase is present at nerve endings and in erythrocytes (red blood cells) but is not present in plasma. Pseudo cholinesterase is present in plasma and liver but is not present in erythrocytes. Measurements obtained by this device are used in the diagnosis and treatment of cholinesterase inhibition disorders (e.g., insecticide poisoning and succinylcholine poisoning).(b)
Classification. Class I (general 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 border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle or other bird with its wings spread, rendered in black. The bird's body is formed by a series of curved lines, giving it a flowing, abstract appearance.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
FEB 2 1 2003
Mr. Michael Campbell Manager, RA/QA Olympus America Inc. 3131 West Royal Lane Irving, TX 75063-3104
Re: K030045
Trade/Device Name: Olympus Cholinesterase Reagent Regulation Number: 21 CFR 862.3240 Regulation Name: Cholinesterase test system Regulatory Class: Class I Product Code: DIH Dated: January 6, 2003 Received: January 6, 2003
Dear Mr. Campbell:
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. Ilsting 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 (OS) regulation (21 CFR Part 820).
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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, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. 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/dsma/dsmamain.html.
Sincerely yours,
Steven Sutman
Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
2
Indications for Use Statement
510(k) Number (if known):
Device Name: Indications for Use: Olympus Cholinesterase Reagent
Reagent for the determination of cholinesterase concentrations in human serum and plasma using the Olympus family of clinical chemistry analyzers.
Measurement of serum cholinesterase has been used to assess liver function and to investigate the variants of cholinesterase enzyme. It is also useful in predicting susceptibility to prolonged apnea after the administration of succinylcholine and in monitoring excessive exposure to organophosphorus insecticides.
Lron Cooper
(Division Sign-Off)
Division of Clinical Laboratory Devices
510(k) Number K030045
0063
(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) |
|---|---|---|
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