(21 days)
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No
The summary describes a standard clinical chemistry analyzer and does not mention any AI or ML capabilities.
No
The device is a clinical chemistry analyzer used for diagnostic purposes, not for treating or preventing disease.
Yes
The device is described as a "Clinical Chemistry Analyzer" used for "clinical laboratory use" and its applications include various analytical techniques like "colorimetric, turbidimetric, latex agglutination, and homogeneous enzyme immunoassay," all of which are methods used to analyze patient samples for diagnostic purposes.
No
The device description clearly states it is a "fully automated photometric analyzer," which is a hardware device. The summary does not mention any software component being the primary or sole medical device.
Yes, based on the provided information, the Olympus AU5400 Clinical Chemistry Analyzer is an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The "Intended Use / Indications for Use" explicitly states it is "intended for clinical laboratory use" and performs tests like "colorimetric, turbidimetric, latex agglutination, and homogeneous enzyme immunoassay." These are all types of tests performed on biological samples outside of the body to diagnose or monitor medical conditions.
- Device Description: While brief, it describes a "fully automated photometric analyzer," which is a common type of instrument used in clinical laboratories for performing IVD tests.
The definition of an IVD device is a medical device that is used to examine specimens, such as blood, urine, or tissue, taken from the human body to provide information for diagnosis, monitoring, or treatment. The description of the Olympus AU5400 aligns perfectly with this definition.
N/A
Intended Use / Indications for Use
The Olympus AU5400 Clinical Chemistry Analyzer is a fully automated photometric analyzer intended for clinical laboratory use. Applications include colorimetric, turbidimetric, latex agglutination, and homogeneous enzyme immunoassay.
Product codes
CIX, CJE, DEM, JFJ, GTQ, JHN, CIT, JZG, CIG, CHS, CGZ, CZW, DBI, DCN, CGS, JLB, CGX, DBF, CFR, DAD, CFQ, CFJ, JIR, DDR, CEO, CEM, CEK, DHR, JGS, DDD, CDQ, JJE, CKA, LKL, JHN, JHN, CHH, JQB, LBS, JIY, JMO, CDT, JGJ, DDS, CDT, CDO
Device Description
The Olympus AU5400 Clinical Chemistry Analyzer is a fully automated photometric analyzer.
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
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.)
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 862.1035 Albumin test system.
(a)
Identification. An albumin test system is a device intended to measure the albumin concentration in serum and plasma. Albumin measurements are used in the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys.(b)
Classification. Class II.
0
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (USA). The seal features a stylized eagle with three stripes forming its body and wing. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.
Public Health Service
JUN 2 5 2001
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Mr. Michael Campbell Manager, Regulatory Affairs/Quality Assurance Olympus America Inc. 3131 West Royal Lane Irving. TX 75063-3104
510(k) Number: K011720 Re: Trade/Device Name: Olympus AU5400 Clinical Chemistry Analyzer
Regulation Number: 862.2160 862.1030 862.1035 862.1050 866.5420 866.5130 862.1070 866.3720 862.1475 862.1475 862.1100 866.5630 862.1110 862.1110 862.1145 862.1160 862.1170 862.1175 866.5240 866.5240 866.5270 862.1215 862.1215 862.1225 866.5340 862.1360 862.1345 866.5460 862.1475 866.5510 866.5510 866.5510 862.1410 862.1415 862.1440 862.1465 862.1495 866.5040 866.5680 862.1580 862.1600 866.5060 862.1635 866.5775 862.1665 866.5880 862.1705 862.1770 862.1775
Regulatory Class: II
Product Code: CIX CJE DEM JFJ GTQ JHN CIT JZG CIG CIG CIG CIG CIG CIG CHS CGZ CZW DBI DCN CGS JLB CGX DBF CFR DAD CFQ CFQ CFQ CFJ JIR DDR
CEO CEM CEK DHR JGS DDD CDQ
Regulatory Class: I
Product Code: JJE CKA LKL JHN JHN CHH JQB LBS JIY JMO CDT JGJ DDS CDT CDO
Dated: June 1, 2001 Received: June 4, 2001
Dear Mr. Campbell:
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 to 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.
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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 Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP 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.
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 vou 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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AU5400 510(K) Premarket Notification Submission
Indications for Use Statement
510(k) Number (if known):
Device Name:
Olympus AU5400 Clinical Chemistry Analyzer
Indications for Use:
The Olympus AU5400 Clinical Chemistry Analyzer is a fully automated photometric analyzer intended for clinical laboratory use. Applications include colorimetric, turbidimetric, latex agglutination, and homogeneous enzyme immunoassay.
(Division Sign-Off) Division of Clinical Laboratory Devices K011720 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) | |
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OR
| Over-The-Counter Use (Optional Format 1-2-96) | |
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