(38 days)
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.
lyophilized human sera intended for use as assayed quality control sera
This is a 510(k) premarket notification for a quality control material and as such, the document primarily focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study description with acceptance criteria for a novel diagnostic device. Therefore, much of the requested information regarding acceptance criteria, study design elements (sample size, expert qualifications, etc.), MRMC studies, standalone performance, and training set details are not typically found in this type of submission.
However, I can extract what is implied regarding equivalence.
Here's the analysis based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
This document does not present a formal table of acceptance criteria with reported device performance in the way a diagnostic device submission might. Instead, the "acceptance criteria" for a quality control material like this is substantial equivalence to a predicate device.
- Acceptance Criteria (Implied): The Microcal Control Serum for Protein Electrophoresis performs equivalently to a legally marketed predicate device in monitoring the precision of cellulose acetate-based protein electrophoresis testing methods. This equivalence is demonstrated through comparative testing.
- Reported Device Performance: The FDA has determined that the device is "substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices."
2. Sample Sizes Used for the Test Set and Data Provenance
- Sample Size (Test Set): Not explicitly stated in this document. Substantial equivalence for a quality control material would typically involve comparing the performance of the new device against the predicate device across a range of analytes and concentrations. The specific number of replicates or runs is not detailed here.
- Data Provenance: Not explicitly stated. For such a device, the data would likely be generated in a laboratory setting. There is no information regarding country of origin or whether the study was retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not Applicable. For a quality control material, the concept of "ground truth" established by experts for a test set, in the way it applies to diagnostic devices, is not relevant. The analytical performance of the control material (e.g., its assigned values, stability) is compared to a predicate, not to an expert-interpreted diagnostic outcome.
4. Adjudication Method for the Test Set
- Not Applicable. As there's no expert interpretation of diagnostic cases, there's no adjudication method in the traditional sense. The equivalence would be determined through analytical comparison.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done
- No. This type of study is not relevant for a quality control material. MRMC studies are typically used for diagnostic imaging devices where human readers interpret medical images, and the AI's impact on their performance is assessed.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- Yes (Implicit). A quality control material like this would be evaluated in a "standalone" analytical performance context, meaning its intrinsic properties and performance are assessed without direct human intervention in its function. However, it's not an "algorithm" in the typical sense of AI/software. The performance of the control material itself is what's being evaluated.
7. The Type of Ground Truth Used
- Predicate Device Performance/Reference Values. The "ground truth" in this context is the established and legally marketed performance of the predicate device, against which the Microcal Control Serum is compared for substantial equivalence in monitoring protein electrophoresis. The values assigned to the control material would also be part of this "ground truth" and are typically established through robust analytical methods.
8. The Sample Size for the Training Set
- Not Applicable. This is a quality control material, not an AI or machine learning algorithm that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. (See point 8).
{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).
{1}------------------------------------------------
Page 2
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
{2}------------------------------------------------
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
Page 1 of 1
§ 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.