(55 days)
Not Found
No
The device description and intended use describe a standard for calibrating a nephelometer, which is a laboratory instrument. There is no mention of AI or ML in the provided text.
No.
The device is a laboratory standard used to establish reference curves for the quantitative determination of human serum proteins; it is not directly used for treating or diagnosing a disease.
No.
The device is described as a liquid standard used to establish reference curves for the quantitative determination of human serum proteins. It is not used to diagnose a medical condition itself, but rather to calibrate other diagnostic devices (Behring Nephelometer Systems).
No
The device description clearly states it is a "liquid standard prepared from human serum with stabilizers and preservative," indicating it is a physical reagent, not software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for "Establishment of reference curves for the determination of IgG, IgG14, IgM, C3c, C4, Transferrin, Albumin, α1-antitrypsin, α2-macroglobulin, Haptoglobin, α--acid glycoprotein, Prealbumin, Ceruloplasmin, RbP, Ig/L-chain lambda & kappa, ß2microglobulin, Soluble transferrin receptor (sTfR), IgE, and Ferritin by immunonephelometry". This describes a process performed in vitro (outside the body) on biological samples (human serum) to obtain diagnostic information (quantitative determination of proteins).
- Device Description: The description confirms it's a "liquid standard prepared from human serum" and is "intended to establish reference curves for the quantitative determination of human serum proteins by immunonephelometry". This further reinforces its use in an in vitro diagnostic procedure.
- Predicate Device: The mention of a predicate device, "N Protein Standard SL (K964062)", which is also a standard used in immunonephelometry, strongly suggests that this type of product is regulated as an IVD.
While the document doesn't contain information about image processing, AI, or clinical performance metrics like sensitivity and specificity (which are more relevant for diagnostic tests themselves, not standards used in those tests), the core function and intended use align perfectly with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Establishment of reference curves for the determination of IgG, IgG+4, IgM, C3c, C4, Transferrin, Albumin, α-antitrypsin, α-macroglobulin, Haptoglobin, α-acid glycoprotein, Prealbumin, Ceruloplasmin, RbP, Ig/L-chain lambda & kappa, ß2-microglobulin, Soluble transferrin receptor (sTfR), IgE, and Ferritin by immunonephelometry with the Behring Nephelometer Systems.
Product codes
JIX
Device Description
N Protein Standard SL is a liquid standard prepared from human serum with stabilizers and preservative. It is intended to establish reference curves for the quantitative determination of human serum proteins by immunonephelometry with the Behring Nephelometer Systems (particle-enhanced nephelometry).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
human serum
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)
Stability was evaluated according to in-house protocols and the standard was found to be Stable for at least 12 months at +2° to +8° C, as originally packaged and for at least 14 days at +2° to +8° C, once opened.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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.
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JUN 1 1999
510(k) Summary For N Protein Standard SL
1. Manufacture's Name, Address, Telephone, and Contact Person, Date of Preparation:
Manufacturer:
Contact Information:
Dade Behring Marburg GmbH Emil-von-Behring Str. 76 Marburg/Germany
Dade Behring Inc. Glasgow Site P.O. Box 6101 Newark, Delaware 19714 Attn: Carolyn K. George Tel: 302-631-6283
Preparation date:
April 5, 1999
Class II (862.1150)
Device Name/ Classification: 2.
Calibrator N Protein Standard SL:
Classification Number:
3. ldentification of the Legally Marketed Device:
N Protein Standard SL (K964062)
Device Description: 4.
N Protein Standard SL is a liquid standard prepared from human serum with stabilizers and preservative. It is intended to establish reference curves for the quantitative determination of human serum proteins by immunonephelometry with the Behring Nephelometer Systems (particle-enhanced nephelometry).
Device Intended Use: 5.
Establishment of reference curves for the determination of IgG, IgG+4, IgM, C3c, C4, Transferrin, Albumin, α-antitrypsin, α-macroglobulin, Haptoglobin, α-acid glycoprotein, Prealbumin, Ceruloplasmin, RbP, Ig/L-chain lambda & kappa, ß2-microglobulin, Soluble transferrin receptor (sTfR), IgE, and Ferritin by immunonephelometry with the Behring Nephelometer Systems.
Medical device to which equivalence is claimed and comparison information: ર.
The N Protein Standard SL (modified to include sTfR) is substantially equivalent in intended use to the N Protein Standard SL (K964062) currently marketed. The N Protein Standard SL (modified), like the current N Protein Standard SL is intended to be used for the calibration of human serum protein assays on the Behring Nephelometer Systems.
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Dade Behring Inc. N Protein Standard SL 510(k) Notification
Device Performance Characteristics: 7.
Stability:
Stability was evaluated according to in-house protocols and the standard was found to be Stable for at least 12 months at +2° to +8° C, as originally packaged and for at least 14 days at +2° to +8° C, once opened.
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the department's logo in the center. The logo consists of a stylized caduceus, which is a symbol of medicine and health. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the perimeter of the circle.
" (ਰਿਰੋਰੇ JUN
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Carolyn K. George Manager, Regulatory Affairs, Biology Dade Behring Inc. P.O. Box 6101 Newark, Delaware 19714
Re: K991181
Trade Name: N Protein Standard SL: Calibrator Regulatory Class: II Product Code: JIX Dated: April 5, 1999 Received: April 7, 1999
Dear Ms. George :
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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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 (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
Steven Butman
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. N Protein Standard SL 510(k) Notification
Indications for Use Statement
Device Name:
N Protein Standard SL
Indications for Use:
Establishment of reference curves for the determination of IgG, IgG14, IgM, C3c, C4, Transferrin, Albumin, α1-antitrypsin, α2-macroglobulin, Haptoglobin, α--acid glycoprotein, Prealbumin, Ceruloplasmin, RbP, Ig/L-chain lambda & kappa, ß2microglobulin, Soluble transferrin receptor (sTfR), IgE, and Ferritin by immunonephelometry with the Behring Nephelometer Systems.
Pete E. Maler
(Division Sion-Division of Clinical La 510(x) Number
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
V Prescription Use (Per 21 CFR 801.109)
Over-The-Counter-Use (Optional Format 1-2-96)
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