(38 days)
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No
The summary describes a quality control material (lyophilized human sera) for protein electrophoresis, with no mention of software, algorithms, or any technology that would incorporate AI/ML.
No
The device is described as quality control sera used to monitor the precision of laboratory tests, not to treat a medical condition.
No
Explanation: The device is described as quality control sera used to monitor the precision of testing methods, not to diagnose a disease or condition in a patient.
No
The device description explicitly states it is "lyophilized human sera," which is a biological material, not software.
Based on the provided information, the device described is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for "monitoring the precision of cellulose acetate based protein electrophoresis testing methods." This indicates it's used in vitro (outside the body) to evaluate the performance of a diagnostic test.
- Device Description: The description "lyophilized human sera intended for use as assayed quality control sera" further supports its use as a control material in laboratory testing.
IVDs are defined as reagents, instruments, and systems intended for use in the diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae. Quality control materials like this are essential components of IVD testing to ensure accuracy and reliability.
N/A
Intended Use / Indications for Use
The Microcal Normal and Abnormal Controls are lyophilized human sera intended for use as assayed quality control sera to monitor the precision of cellulose acetate based protein electrophoresis testing methods.
Product codes
JJX
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
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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
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§ 862.1660 Quality control material (assayed and unassayed).
(a)
Identification. A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.(b)
Classification. Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.
0
DEPARTMENT OF HEALTH & HUMAN SERVICES
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 stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular pattern around the symbol. The logo is black and white.
Public Health Service
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
AUG 1 6 2004
InterLab Scientific Instruments c/o Mr. Gary Lehnus Trouble Shooter Consulting, Inc. 150 Cherry Lane Rd. East Stroudsburg, PA 18301-8804
K041871 Re:
Ko+1671
Trade/Device Name: Microcal Control Serum for Protein Electrophoresis Regulation Number: 21 CFR 862.1660 Regulation Name: Quality control material Regulatory Class: Class I Product Code: JJX Dated: July 07, 2004 Received: July 27, 2004
Dear Mr. Lehnus:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bector of the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosure) to regally the enactment date of the Medical Device Amendments, or to Commerce provision of they 20, 1970, the occordance with the provisions of the Federal Food, Drug, devices may nave been roomstilled in quire approval of a premarket approval application (PMA). You may, iherefore, market the device, subject to the general controls provisions of the Act. The r ou may, mercisions of the Act include requirements for annual registration, listing of general controls provisions of nactice, 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 your device is thassified (controls. Existing major regulations affecting your device it may be subject it back acceral Regulations (CFR), Parts 800 to 895. In addition, FDA can be found in This =========================================================================================================================================================
Please be advised that FDA's issuance of a substantial equivalence determination does not mean I least of advisou and I Drivination that your device complies with other requirements of the Act that I Dr has made a statutes and regulations administered by other Federal agencies. You must of any I catal statutes and regirements, including, but not limited to: registration and listing (21 comply with an the 110 - 12 CFR Parts 801 and 809); and good manufacturing practice CFR Part 807), tabelies in the quality systems (QS) 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) I mb lotect 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 guestions 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,
Sean M. Cooper US, DVM
MS, DVM
Jean M. Cooper, MS, D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): __KO4 i8 7 /
Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications For Use:
The Microcal Normal and Abnormal Controls are lyophilized human sera intended for use as assayed quality control sera to monitor the precision of cellulose acetate based protein electrophoresis testing methods.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Caul Benen
Division Sign-Off
Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) KC4/871
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