(57 days)
Apolipoprotein Control Serum CHD is used as an assayed control for accuracy and precision in the quantitative immunochemical determination of Apolipoprotein A-I and B by radial immunodiffusion; Apolipoprotein A-I, All*, B, E* and CRP with the Behring Nephelometer Systems; and Apolipoprotein A-I, B and Myoglobin with the TurbiTime System™ * Reagents for these determinations are not available in USA
Apolipoprotein Control Serum CHD is a lyophilized reagent prepared from human serum with stabilizers and preservative. The product is calibrated against different protein standard preparations including in-house and commercially available reference preparations.
This submission is for a quality control material (Apolipoprotein Control Serum CHD) and therefore the typical acceptance criteria and study designs for diagnostic devices are not applicable in the same way. The primary goal is to demonstrate that the control material is substantially equivalent to an existing legally marketed predicate device. This means showing that it performs similarly and serves the same purpose as the predicate, not that it achieves a specific diagnostic performance metric.
Therefore, many of the requested categories (e.g., sample size for test/training sets, experts for ground truth, MRMC study, standalone performance) are not relevant or not present in this documentation for a quality control product.
Here's an interpretation based on the provided text for a quality control material:
1. Table of Acceptance Criteria and Reported Device Performance
For a quality control material, "acceptance criteria" revolve around its intended use and composition being substantially equivalent to a predicate device, ensuring it functions appropriately to monitor the performance of assays. "Device performance" is typically about its characteristics being consistent with or comparable to the predicate.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Intended Use: Assayed control for accuracy and precision in quantitative immunochemical determinations. | Intended Use: Assayed control for accuracy and precision in the quantitative immunochemical determination of specified apolipoproteins and CRP/Myoglobin. |
| Analytes: Comparable or expanded panel. | Analytes: Apolipoprotein A-1, AII, B, E, myoglobin, and CRP. (Note: Expanded compared to predicate which listed A-1, AII, B, E, and myoglobin). |
| Matrix: Stabilized reagent from human serum. | Matrix: Stabilized reagent from human serum. |
| Form: Lyophilized. | Form: Lyophilized. |
| Volume: 0.5 ml per vial. | Volume: 0.5 ml per vial. |
| Compatibility: Compatible with specified assay systems (Radial Immunodiffusion, Behring Nephelometer Systems, TurbiTime System™). | Compatibility: Used with Radial Immunodiffusion, Behring Nephelometer Systems, and TurbiTime System™. |
2. Sample Size Used for the Test Set and Data Provenance
Not applicable in the context of a 510(k) submission for a quality control material. There is no "test set" of patient data to evaluate diagnostic accuracy. The submission focuses on product characteristics and substantial equivalence to a predicate.
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. "Ground truth" in this context would refer to the true values of analytes in the control material, which are established by the manufacturer through rigorous characterization and calibration, often against reference materials. This is an internal manufacturing and validation process, not a clinical expert review.
4. Adjudication Method for the Test Set
Not applicable. There is no "test set" in the diagnostic performance sense that would require expert adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a quality control material, not a diagnostic device involving human readers or AI assistance.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a biochemical control material, not an algorithm.
7. The Type of Ground Truth Used
For a quality control material, the "ground truth" for the assigned values of the analytes within the control serum is established by:
- Calibration against different protein standard preparations: This includes in-house and commercially available reference preparations.
- Assay-specific determination: The control is "assayed" for accuracy and precision in specific immunochemical determination methods, implying that the expected values are derived from testing it with the very clinical assays it is intended to control.
Therefore, the ground truth is based on calibration against reference standards and empirical determination using established assay methods, rather than clinical outcomes or pathology.
8. The Sample Size for the Training Set
Not applicable. This device is a manufactured reagent, not a machine learning algorithm that requires a "training set."
9. How the Ground Truth for the Training Set was Established
Not applicable as there is no training set for this type of device. The "ground truth" (i.e., assigned values) for the control serum is established through the manufacturer's internal calibration and characterization processes as described in point 7.
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510(k) Summary For Apolipoprotein Control Serum CHD
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
| Submitter's Name: | Donna A. WolfDade Behring Inc.P. O. Box 6101Newark, Delaware 19714Tel: 302-631-0384 |
|---|---|
| Preparation Date: | September 30, 1999 |
| Device Name / Classification: | Apolipoprotein Control Serum CHDQuality Control Material (assayed) |
| Predicate Device: | Apolipoprotein Control Serum (K903687) |
Device Description: Apolipoprotein Control Serum CHD is a lyophilized reagent prepared from human serum with stabilizers and preservative. The product is calibrated against different protein standard preparations including in-house and commercially available reference preparations.
Device Intended Use: Apolipoprotein Control Serum CHD is used as an assayed control for accuracy and precision in the quantitative immunochemical determination of apolipoprotein A-I and B by radial immunodiffusion, apolipoprotein A-I, All*, B, E* and CRP with the Behring Nephelometer Systems, or apolipoprotein A-1, B and Myoglobin with the TurbiTime System™
*Reagents for these determinations are not available in the USA.
Comparison to Predicate Device:
| Apolipoprotein ControlSerum CHD (modified) | Apolipoprotein ControlSerum (K903687) | |
|---|---|---|
| Intended Use | Assayed control | Assayed control |
| Analytes | Apolipoprotein A-1, AII, B, E,myoglobin and CRP | Apolipoprotein A-1, AII, B, E,and myoglobin |
| Matrix | Stabilized reagent fromhuman serum | Stabilized reagent fromhuman serum |
| Form | Lyophilized | Lyophilized |
| Volume | 0.5 ml per vial | 0.5 ml per vial |
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Dade Behring Inc. Apolipoprotein Control 510(k) Notification
Comments on Substantial Equivalence: Both the Apolipoprotein Control Serum CHD and the Apolipoprotein Control are similar products. Both products are intended for use as a quality control material to monitor accuracy and precision of human serum protein assays using radial immunodiffusion, the Behring Nephelometer Systems, and the TurbiTime System™.
Conclusion: The Apolipoprotein Control Serum CHD is substantially equivalent to the Apolipoprotein Control Serum based on the comparison summarized above.
Donna A. Wolf
Regulatory Affairs and Compliance Specialist Date: September 30, 1999
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a stylized symbol. The symbol consists of three abstract shapes resembling human figures or birds in flight. The logo is presented in black and white.
NOV 30 1999
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Donna A. Wolf Regulatory Affairs Specialist. Biology Dade Behring, Inc. P.O. Box 6101 Newark, Delaware 19714
Re: K993310 Trade Name: Apolipoprotein Control Serum CHD Regulatory Class: I Product Code: JJY Dated: September 30, 1999 Received: October 4, 1999
Dear Ms. Wolf:
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 legally marketed predicate 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.
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 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 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.
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Page 2
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 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 Putman
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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Dade Behring Inc. Apolipoprotein Control 510(k) Notification
Nov 30 1999
K993310
Indications for Use Statement
Device Name:
Apolipoprotein Control Serum CHD
Indications for Use:
Apolipoprotein Control Serum CHD is used as an assayed control for accuracy and precision in the quantitative immunochemical determination of
Apolipoprotein A-I and B by radial immunodiffusion;
Apolipoprotein A-I, All*, B, E* and CRP with the Behring Nephelometer Systems;
and Apolipoprotein A-I, B and Myoglobin with the TurbiTime System™
- Reagents for these determinations are not available in USA
Peter E. Madoni
(Division Sign-Off)
Division of Clinical Laboratory Devices K993310
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 21CFR801.109)
Over-The-Counter-Use (Optional Format 1-2-96)
000000
CONFIDENTIAL
§ 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.