(22 days)
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Not Found
No
The summary does not mention AI, ML, or any related concepts like image processing, training sets, or performance metrics typically associated with AI/ML devices. The description is purely of a standard photometric analyzer.
No
This device is a clinical chemistry analyzer used for diagnostic purposes in a laboratory setting, not for treating diseases or conditions.
Yes
Justification: The device is described as a "Photometric clinical chemistry analyzer for clinical laboratory use," which performs "colorimetric, turbidimetric, latex agglutination and homogenous enzyme immunoassay." These are all techniques used to analyze biological samples to help diagnose diseases or monitor health conditions, fitting the definition of a diagnostic device.
No
The device description explicitly states it is a "Photometric clinical chemistry analyzer," which is a hardware device used for laboratory analysis. There is no mention of it being a software-only component.
Based on the provided information, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states "Photometric clinical chemistry analyzer for clinical laboratory use." Clinical chemistry analyzers are used to perform tests on biological samples (like blood, urine, etc.) in vitro (outside the body) to diagnose or monitor medical conditions.
- Device Description: The description "Photometric clinical chemistry analyzer" further supports its function as an IVD.
- Intended User / Care Setting: "clinical laboratory use" is the typical setting for performing IVD tests.
The other sections being "Not Found" (like image processing, AI, performance studies, etc.) do not negate its classification as an IVD based on its core function and intended use.
N/A
Intended Use / Indications for Use
Photometric clinical chemistry analyzer for clinical laboratory use. Applications include colorimtric, turbidimetric, latex agglutination and homogenous enzyme immunoassay.
Product codes
CKB, CIX, CJE, JFJ, JHN, CIT, CIG, DCN, CZW, DGI, CIC, CHH, CHJ, CGS, JLB, CGX, DEF, CFR, CEO, JIY, CFQ, JMO, JGS, JGJ, DHR, DOD, CDQ, CDQ
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
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
clinical laboratory use.
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.)
Not Found
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.
Not Found
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.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 862.1020 Acid phosphatase (total or prostatic) test system.
(a)
Identification. An acid phosphatase (total or prostatic) test system is a device intended to measure the activity of the acid phosphatase enzyme in plasma and serum.(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.
0
Image /page/0/Picture/2 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized symbol consisting of three curved lines that resemble a human figure.
a 1998 JUN
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Laura Storms-Tyler Director, Regulatory Affairs Olympus America, Inc. Two Corporate Center Drive Melville, NY 11747
Re: K981743 Trade Name: Reagents for the Olympus AU400 Clinical Chemistry Analyzer Regulatory Class: I, II CKB, CIX, CJE, JFJ, JHN, CIT, CIG, DCN, CZW, DGI, CIC, Product Codes: CHH, CHJ, CGS, JLB, CGX. DEF, CFR, CEO, JIY, CFQ, JMO, JGS, JGJ, DHR, DOD, CDQ, CDQ Dated: May 14, 1998 Received: May 18, 1998
Dear Ms. Storms-Tyler:
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 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) ble 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 vour 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 Sutman
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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Indications for Use Statement
510(k) Number (if known):
Not assigned yet
Device Name:
Olympus AU400 Clinical Chemistry Analyzer
Indications for Use:
Photometric clinical chemistry analyzer for clinical laboratory use. Applications include colorimtric, turbidimetric, latex agglutination and homogenous enzyme immunoassay.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use (per 21CFR 801.109) | OR | Over-the Counter Use (Optional Format 1-2-96) | |
|---|---|---|---|
| -------------------------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------- | ---- | ----------------------------------------------- |
(Division Sign-Off)
Division of Clinical Laboratory Devices
| 510(k) Number | K981743 |
|---|---|
| --------------- | --------- |