(42 days)
Behring Nephelometer Systems, TurbiTimeSystem
No
The document describes a protein control solution used for calibrating and quality control of immunonephelometry and immunoturbidimetry systems. There is no mention of AI or ML in the intended use, device description, or performance studies.
No
The device is described as a control for determining human serum proteins by immunonephelometry and immunoturbidimetry, and for quality control in total protein assays. It is not intended to treat or mitigate a disease or condition.
No
An in vitro diagnostic device is one that performs a diagnostic test (e.g. measures the presence or amount of a substance in a body fluid or tissue). This device is a control used in diagnostic tests, not a diagnostic device itself.
No
The device description explicitly states it is a "liquid control prepared from human serum with stabilizers and preservative," indicating it is a physical reagent, 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 that the controls are for use in the "determination of the following human serum proteins by immunonephelometry with the Behring Nephelometer Systems" and "by immunoturbidmetry with the TurbiTimeSystem". These are laboratory methods used to analyze biological samples (human serum) to provide information about a person's health.
- Device Description: The device is described as a "liquid control prepared from human serum". Controls are essential components in IVD testing to ensure the accuracy and reliability of the results.
- Context: The entire description revolves around laboratory testing of human serum proteins using specific analytical systems.
The definition of an IVD is a medical device that is used to perform tests on samples such as blood, urine, or tissues to detect diseases or other conditions. This device fits that description as it's used in laboratory tests on human serum.
N/A
Intended Use / Indications for Use
N/T Protein Controls SL/L, M, and H are for use as accuracy and precision assayed controls in the determination of the following human serum proteins by immunonephelometry with the Behring Nephelometer Systems: IgG, IgGirl IgA, IgM, C3c, C4, Transferrin, Albumin, a-antitrypsin, α2-macroglobulin, Haptoglobin, a - acid glycoprotein, Prealbumin, Ceruloplasmin, RbP, Ig/L-chain lambda & kappa, β>-microglobulin, Soluble transferrin receptor (sTfR), Ferritin, lgE; and, by immunoturbidmetry with the TurbiTimeSystem: (gG, IgGj1, IggA, controls con also be has be haptoglobin, a ;- acid glycoprotein, The controls can also be used for quality control in the Total Protein assay, using the Behring Nephelometer Systems.
Product codes
JJY
Device Description
N/T Protein Control SL is a liquid control prepared from human serum with stabilizers and Nr 1 rotein Oontrol October of a liquia contracy and precision control for the preservative: 16 minin serum proteins by immunonephelometry with the Behring Nephelometer Systems and by immunoturbidimetry with the TurbiTimeSystem.
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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Stability was evaluated according to in-house protocols and the control 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
§ 862.1660 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
MAY 19 1999
Dade Behring Inc.
N/T Protein Control SL
510(k) Notification
Image /page/0/Picture/1 description: The image shows a black and white picture with some dark shapes on the left side and the text "K991182" on the right side. The shapes on the left are abstract and do not have a clear form. The text is handwritten in a cursive style. The text appears to be a code or identification number.
510(k) Summary For N/T Protein Control SL
Manufacture's Name, Address, Telephone, and Contact Person, Date of 1. 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
Device Name/ Classification: 2.
N/T Protein Control SL:
Classification Number:
Class I (862.1660)
Quality Control Material (assayed)
Identification of the Legally Marketed Device: 3.
N/T Protein Control SL (K964065)
Device Description: 4.
N/T Protein Control SL is a liquid control prepared from human serum with stabilizers and Nr 1 rotein Oontrol October of a liquia contracy and precision control for the preservative: 16 minin serum proteins by immunonephelometry with the Behring Nephelometer Systems and by immunoturbidimetry with the TurbiTimeSystem.
Device Intended Use: ક.
N/T Protein Controls SLIL, M, and H are for use as accuracy and precision controls in the 14/11 Toteln Gontrolo ODE, will han serum proteins by immunonephelometry with the delehring Nephelometer Systems: IgG, IgG+++ IgA, IgM, C3c, C4, Transferrin, Albumin, a++ antitrypsin, a2-macroglobulin, Haptoglobin, a1-acid glycoprotein, Prealbumin, antil Jpoin, αշ maorogiou & kappa, βչ-microglobulin, Soluble transferrin, Soluble transferrin, Gerdloplasmin, Nor , igre onain larks and by immunoturbidmetry with the TurbiTimeSystem: IgG, roopler (GTTT), COMAN), C3c, C4, Transferrin, Albumin, Haptoglobin, x1-acid glycoprotein, The rg of in the many be used for quality control in the Total Protein assay, using the Behring Nephelometer Systems.
1
Dade Behring Inc. N/T Protein Control SL 510(k) Notification
Medical device to which equivalence is claimed and comparison information: 6.
The N/T Protein Control SL (modified to include sTfR) is substantially equivalent in intended use to the N/T Protein Control SL (K964065) currently marketed. The N/T Control SL (modified), like the current N/T Protein Control SL is intended to be used as quality control material to monitor the accuracy and precision of human serum protein assays on the Behring Nephelometer Systems and TurbiTimeSystem.
7. Device Performance Characteristics:
Stability:
Stability was evaluated according to in-house protocols and the control 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.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows a partial view of a logo or emblem, featuring the text 'DEPARTMENT OF HEALTHY & H'. The text is arranged in a curved manner, suggesting it forms part of a circular design. Adjacent to the text are abstract, curved lines, possibly representing a stylized graphic element or symbol associated with the department.
MAY 1 9 1993
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
Ms. Carolyn K. Goorge Manager, Regulatory Affairs, Biology Dade Behring Inc. P.O. Box 6101 Newark, Delaware 19714
Re: K991182
Trade Name: N/T Protein Control SL: Quality Control Material Regulatory Class: 1 Product Code: JJY 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 latt 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 adultcration.
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 cquivalent 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 unight 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 procced 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/cdrl/dsma/dsmamain.html".
Sincerely yours,
Steven Autman
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/T Protein Control SL 510(k) Notification
Indications for Use Statement
Device Name: N/T Protein Control SL
Indications for Use:
N/T Protein Controls SL/L, M, and H are for use as accuracy and precision assayed controls in the determination of the following human serum proteins by immunonephelometry with the Behring Nephelometer Systems: IgG, IgGirl IgA, IgM, C3c, C4, Transferrin, Albumin, a-antitrypsin, α2-macroglobulin, Haptoglobin, a - acid glycoprotein, Prealbumin, Ceruloplasmin, RbP, Ig/L-chain lambda & kappa, β>-microglobulin, Soluble transferrin receptor (sTfR), Ferritin, lgE; and, by immunoturbidmetry with the TurbiTimeSystem: (gG, IgGj1, IggA, controls con also be has be haptoglobin, a ;- acid glycoprotein, The controls can also be used for quality control in the Total Protein assay, using the Behring Nephelometer Systems.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| (Division Sign-Off) | |
| Division of Clinical Laboratory Devices | |
| 510(k) Number F791182 | |
| Prescription Use | |
| (Per 21 CFR 801.109) | Over-The-Counter-Use |
| (Optional Format 1-2-96) |
CONFIDENTIAL