(57 days)
Not Found
No
The summary describes a control serum for laboratory tests and explicitly states "Mentions AI, DNN, or ML: Not Found".
No
Explanation: The device is described as an assayed control serum used for accuracy and precision in quantitative immunochemical determinations, indicating it's a diagnostic or laboratory reagent, not a therapeutic agent.
No
The device is described as an "assayed control" used for accuracy and precision in quantitative immunochemical determinations, indicating it's a control material for diagnostic tests rather than a diagnostic device itself.
No
The device is a lyophilized reagent prepared from human serum, which is a physical substance, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it is used as a control for the quantitative immunochemical determination of various Apolipoproteins and CRP. These determinations are performed in vitro (outside the body) on biological samples (serum).
- Device Description: The device is a lyophilized reagent prepared from human serum, which is a biological sample. It is used in laboratory settings to assess the accuracy and precision of diagnostic tests.
- Predicate Device: The mention of a predicate device (K903687; Apolipoprotein Control Serum) further supports its classification as an IVD, as predicate devices are typically other IVD products.
Therefore, based on the provided information, the Apolipoprotein Control Serum CHD fits the definition of an In Vitro Diagnostic device.
N/A
Intended Use / 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, or Apolipoprotein A-1, B and Myoglobin with the TurbiTime System™. *Reagents for these determinations are not available in the USA.
Product codes
JJY
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Apolipoprotein Control Serum (K903687)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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
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. Wolf
Dade Behring Inc.
P. O. Box 6101
Newark, Delaware 19714
Tel: 302-631-0384 |
|-------------------------------|-----------------------------------------------------------------------------------------------------|
| Preparation Date: | September 30, 1999 |
| Device Name / Classification: | Apolipoprotein Control Serum CHD
Quality 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 Control
Serum CHD (modified) | Apolipoprotein Control
Serum (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 from
human serum | Stabilized reagent from
human serum |
| Form | Lyophilized | Lyophilized |
| Volume | 0.5 ml per vial | 0.5 ml per vial |
1
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
2
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.
3
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
4
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