(57 days)
Not Found
No
The summary describes a protein standard used for calibration in a nephelometry system, with no mention of AI or ML.
No.
The device is a protein standard used for preparing reference curves in diagnostic tests, not for directly treating or diagnosing a medical condition.
No
The device is a protein standard used for preparing reference curves for immunonephelometric determinations. It is a calibrator, not a diagnostic device itself.
No
The device description clearly states it is a lyophilized standard prepared from human urinary proteins, indicating it is a physical substance, not software.
Based on the provided information, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for "preparing reference curves for the immunonephelometric determinations of α-microglobulin in urine". This involves testing a sample (urine) outside of the body to obtain diagnostic information.
- Device Description: The description confirms it's a "standard prepared from human urinary proteins" used to "establish reference curves for the quantitative determination of a - microglobulin by immunonephelometry". This further reinforces its role in an in vitro diagnostic test.
- Predicate Device: The mention of a predicate device (K904254; Protein Standard Urine Concentrate) which is also likely an IVD standard, supports the classification of this device as an IVD.
The core function of this device is to serve as a standard within an in vitro diagnostic test (immunonephelometry) to quantify a substance (α-microglobulin) in a biological sample (urine). This directly aligns with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
N Protein Standard UY is intended for preparing reference curves for the immunonephelometric determinations of α-microglobulin in urine using the Behring Nephelometer Systems.
Product codes (comma separated list FDA assigned to the subject device)
JIT
Device Description
N Protein Standard UY (lyophilized) is a standard prepared from human urinary proteins with polygeline and preservative. It is intended to establish reference curves for the quantitative determination of a - microglobulin 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
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)
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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
§ 862.1150 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.
0
JUL 15 1999
510(k) Summary For N Protein Standard UY
Manufacture's Name, Address, Telephone, and Contact Person, Date of 1. Preparation:
| Manufacturer: | Dade Behring Marburg GmbH
Emil-von-Behring Str. 76
Marburg/Germany |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------|
| Contact Information: | Dade Behring Inc.
Glasgow Site
P.O. Box 6101
Newark, Delaware 19714
Attn: Rebecca S. Ayash
Tel: 302-631-6276 |
| Preparation date: | May 19, 1999 |
2. Device Name/ Classification:
N Protein Standard UY:
Calibrator
Class II (862.1150) Classification Number:
3. ldentification of the Legally Marketed Device:
Protein Standard Urine Concentrate (K904254)
Device Description: 4.
N Protein Standard UY (lyophilized) is a standard prepared from human urinary proteins with polygeline and preservative. It is intended to establish reference curves for the quantitative determination of a - microglobulin by immunonephelometry with the Behring Nephelometer Systems (particle enhanced nephelometry).
5. Device Intended Use:
N Protein Standard UY is intended for preparing reference curves for the immunonephelometric determinations of α-microglobulin in urine using the Behring Nephelometer Systems.
- Medical device to which equivalence is claimed and comparison information: રે.
There are a number of in vitro diagnostic products that are used for the establishment of reference curves. One such product is the Protein Standard Urine Concentrate (K904254). The N Protein Standard UY is substantially equivalent in intended use to the Protein Standard Urine Concentrate. The N Protein Standard UY, like The Protein Standard Urine Concentrate is intended to be used for the calibration of an a1microglobulin assay on the Behring Nephelometer Systems.
7. Device Performance Characteristics:
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.
OOOUS
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the top half of the circle. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.
JUL 15 1999
Ms. Rebecca S. Ayash Manager, Regulatory Affairs, Biology DADE BEHRING INC. Glasglow Site P.O. Box 6101 Newark, Delaware 19714
Re: K991705 Trade Name: N Protein Standard UY Regulatory Class: II Product Code: JIT Dated: May 19, 1999 Received: May 19, 1999
Dear Ms. Ayash:
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 (OS) 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.
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
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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 Sutman
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
3
Dade Behring Inc. 510/k) Notification
K991705
Indications for Use Statement
N Protein Standard UY Device Name:
Indications for Use:
N Protein Standard UY is intended for preparing reference curves for the immunonephelometric determinations of α-microglobulin in urine using the Behring Nephelometer Systems.
Alan Cooper
(Division Sign-Off)
Division of Clinical Laboratory...vicx
510(k) Number K991705
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) {
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
Over-The-Counter-Use (Optional Format 1-2-96)
000007