(84 days)
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No
The 510(k) summary describes a chemical calibrator for laboratory analyzers and contains no mention of AI or ML technology.
No
The device is a multicalibrator used in clinical chemistry analyzers for diagnostic determinations, not for treating a disease or condition.
Yes
The device is described as a multicalibrator for determining specific proteins in clinical chemistry analyzers, which are used to measure analytes for diagnostic purposes.
No
The 510(k) summary describes a "Serum Protein Multicalibrator," which is a reagent used in clinical chemistry analyzers. This is a physical substance, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's "designed for use in Olympus automated clinical chemistry analyzers for α-1-acidoglycoprotein, α-1-antitrypsin, haptoglobin and ß-2-microglobulin determinations." These determinations are performed on biological samples (serum, as indicated by the product name "Serum Protein Multicalibrator") outside of the body (in vitro) to provide information about a person's health.
- Device Type: A calibrator is a substance used to establish the relationship between the signal produced by an analytical instrument and the concentration of the analyte being measured. Calibrators are essential components of many in vitro diagnostic tests.
Therefore, based on its intended use and function as a calibrator for clinical chemistry determinations, the Olympus Serum Protein Multicalibrator fits the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Olympus Serum Protein Multicalibrator, catalog number ODR3023, is designed for use in Olympus automated clinical chemistry analyzers for α-1-acidoglycoprotein, α-1-antitrypsin, haptoglobin and ß-2-microglobulin determinations.
Product codes
JIT
Device Description
Olympus Serum Protein Multi-Calibrator, catalog number ODR3023
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
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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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Food and Drug Administration 2098 Gaither Road Rockville MD 20850
AUG 1 8 1998
Laura Storms-Tyler Director, Regulatory Affairs Olympus America, Inc. Two Corporate Center Drive Melville, New York 11747
Re: K981854 Serum Protein Multicalibrator Requlatory Class: II Product Code: JIT Dated: July 21, 1998 Received: July 23, 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 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 qeneral 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 requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਕੇ 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 requlation may result in requlatory 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 = = requlations.
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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 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 (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Steven Gutman
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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Indications for Use Statement
510(k) Number (if known): Not assigned yet
Device Name:
Olympus Serum Protein Multi-Calibrator
Indications for Use:
The Olympus Serum Protein Multicalibrator, catalog number ODR3023, is designed for use in Olympus automated clinical chemistry analyzers for α-1-acidoglycoprotein, α-1-antitrypsin, haptoglobin and ß-2-microglobulin determinations.
(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 | K981854 |