(59 days)
Not Found
Not Found
No
The summary focuses on the intended use with reagents for determining constituent values in human serum and does not mention any AI or ML technologies.
No
Explanation: The device is intended for establishing reference points to determine values for specific constituents in human serum, which is a diagnostic function, not a therapeutic one.
Yes
The device is used to determine values for specific constituents in human serum, which is a common practice in diagnostic testing to identify or monitor health conditions.
No
The 510(k) summary describes a device intended for use with "Olympus reagents" to establish reference points for constituents in human serum. This strongly implies a laboratory instrument or system that utilizes physical reagents and processes biological samples, which is not a software-only device. The lack of a device description further supports this interpretation as it doesn't provide any information suggesting a software-only nature.
Based on the provided information, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for "the establishment of reference points used in the determination of values for specific constituents found in human serum." This involves analyzing a biological sample (human serum) in vitro (outside the body) to obtain information about a person's health status.
- Sample Type: The device is used with "human serum," which is a biological specimen.
- Constituents Measured: It measures specific constituents (ceruloplasmin, alpha-l-acidglycoprotein, alpha-2-macroglobulin, haptoglobin, and beta-2-microglobulin) in the serum. Measuring these substances in a biological sample is a core function of IVDs.
The definition of an IVD generally includes devices intended for use in the examination of specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device fits that description by providing reference points for determining values of specific constituents in human serum, which would be used in a diagnostic or monitoring context.
N/A
Intended Use / Indications for Use
Intended for use with Olympus reagents for the establishment of reference points used in the determination of values for specific constituents found in human serum. The five constituents are ceruloplasmin, alpha-1-acidglycoprotein, alpha-2-macroglobulin, haptoglobin, and beta-2-microglobulin.
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
human serum
Indicated Patient Age Range
Not Found
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
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Key Metrics
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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
Not Found
§ 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.
0
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" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, representing the department's mission to protect the health of all Americans.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
400-1999 1999
Ms. Laura Storms-Tyler Director, Regulatory Affairs Olympus America, Inc. Two Corporate Center Drive Melville, New York 11042
K992086 Re:
Trade Name: Olympus® Serum Protein Multicalibrator 2 Regulatory Class: II Product Code: JIX Dated: April 27, 1999 Received: June 21, 1999
Dear Ms. Storms-Tyler:
We have reviewed your Section 510(k) notification of intent to market the device referenced we nave leviewed your becaon 9 ro(x) xe is substantially equivalent (for the indications for use above and we nave determinou and actresed predicate devices marketed in interstate commerce stated in the enclosure) to logary manote = p.the Medical Device Amendments, or to devices that provi to May 20, 1970, the charances with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls Cosment Act (Act. The general controls provisions of the Act include requirements for annual provisions of the Act. "The general conaufacturing 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 (Fremarks) Approval), it may of says. It is a code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good A substantially equiralient determinates 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 inspections, the rood and Drug Nammountin (1 Directory action. In addition, FDA may publish comply with the Grill regareming your device in the Federal Register. Please note: this response to your premarks concerning your 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.
1
Page 2
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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may
Under the Clinical Laboratory Improvement Amendments of 1988 (CEIFF 09) 2007 (1978)
require a CLIA complexity categorization. To determine if it does, you should contact the ones.
Centers for Disease Control and Prevention (CDC) at (770) 488-7655.
Centers for Disease Control and Prevention (CDC) at (770) 488-7655.
Centers for Discase Control and 1914 - 1978
This letter will allow you to begin marketing your device as described in your 10(k) premarket
1978 - The FDA firding of substan This letter will allow you to begin marketing your device to a legally for to a legally marketed
notification. The FDA finding of substantial equivalence of your device to This letter will and with to substantial equivalence of your device to a vogal your device to
predicate device results in a classification for your device and thus, permits y proceed to the market.
proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and If you desire specific advice for your devices), please contact the Office of Compliance at
additionally 809.10 for in vitro diagnostic devices), please contact the Organisat If you desire specific dagnostic devices on the prince of contract of cour device,
(301) 594-458. Additionally, for questions on the prince of courtes and (301) 594-4588. Additionally, for questions on the promotion and aboveristials de yeallation
(301) 594-4588. Additionally, for questions on the promotion of Sundan (301) 394-4388. Auditions) (201) 594-4639. Also, please note 2.60 States (201) (2010-02-01) Politico (201) School States (201) Colbi of Smark
entitled, "Misbranding by r please contact are of the concerties notification (2) CFA 0017 ) CPN of Small
entitled, "Misbranding by refective to premarket motifican of Small
information on your respons entitled, "Assistance at its toll-free mumber (800) 638-2041 or (301) 443-6597, or at its
Manufacturers Assistance ai its toll-free mumber (800) 638-2041 or (301) 443-6597, Manufacturers Assistance at Its toll-free humor (000)
internet address "http://www.fda.gov/cdrl/dsma/dsmamain.html".
Internet address "http://www.fda.gov/cdrl/dsmaldsmamain.h
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
Enclosure
2
510(k) Number (if known):
Device Name:
Olympus Serum,Protein Multicalibrator 2
Indications for Use:
ansiness for use with Olympus reagents for the establishment of Intended for use with Olympus reagents for the country.
reference points used in the determination of values for specific reference points ascu in to
constituents found in human serum.
The five constituents are ceruloplasmin, alpha-l-acidglycoprotein,
constituents are ceruloplasmin and beta-2-microglobulin. The five constituents are ceruloplabili, and beta-2-microgloulin.
H an Cooper
(Division Sign-Off)
Division of Clinical Laboratory Devices 510(k) Number. 1992086
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Presciption Use (per 21CFR 801.109) OR
Over-the Counter Use_
(Optional Format 1-2-96)