(178 days)
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No
The device description details a standard immunoturbidimetric assay based on chemical reactions and optical density measurements, with no mention of AI or ML algorithms for data processing or interpretation.
No.
This device is an in-vitro diagnostic assay used to quantify prealbumin levels, which aids in assessing nutritional status. It does not directly treat or alleviate a disease or condition.
Yes
The device quantitatively determines prealbumin levels in human serum and plasma, which aids in assessing a patient's nutritional status. This information can be used by a medical professional to make a diagnosis regarding malnutrition or other health conditions related to prealbumin levels.
No
The device description clearly outlines a laboratory assay that uses reagents and measures turbidity, indicating a physical, in-vitro diagnostic device, not software.
Based on the provided information, this device is indeed an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use / Indications for Use: The description explicitly states "Immunoturbidometric assay for the quantitative in-vitro determination of Prealbumin" and "Immunological latex agglutination test for the in vitro quantitative determination of prealbumin in human serum and plasma." The phrase "in vitro" is a key indicator of an IVD.
- Device Description: The description details a test performed on a "serum or plasma blood sample," which is a biological sample taken from the body and tested outside of it. This aligns with the definition of an in vitro test.
- Measurement of Prealbumin: The purpose is to measure a substance (Prealbumin) in a biological sample to aid in the assessment of a patient's nutritional status. This is a common application of IVDs.
Therefore, all the provided information points to this device being an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Immunoturbidometric assay for the quantitative in-vitro determination of Prealbumin.
Immunological latex agglutination test for the in vitro quantitative determination of prealbumin in human serum and plasma.
Measurement of prealbumin levels in serum may aid in the assessment of the patient's nutritional status.
Product codes
JZJ
Device Description
The Prealbumin determination is based upon turbidimetric immunoinhibition (TINIA) using a serum or plasma blood sample. The sample containing Prealbumin is transferred into a TRIS buffer solution (R₁ reagent). In the second step, an aliquot of solution of polyclonal anti-human Prealbumin antibodies (R₂ reagent) is added to mixture of the first step. The antibody binds to the Prealbumin in the sample to form "aggregates" such that the amount of aggregate formed is proportionate to the amount of Prealbumin present in the sample.
The resulting agglutination complex is measured turbidimetrically whereby increased turbidity is reflected through an increase in optical density. Therefore, the amount of Prealbumin in the sample is directly proportional to the amount of turbidity formed.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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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)
Precision
- Tina-quant® Prealbumin
- Intra-Assay (mg/dL):
- Level: Low, Sample, High
- N: 21, 21, 21
- Mean: 27.8, 30.1, 58.7
- %CV: 3.6, 3.0, 2.4
- Inter-Assay (mg/dL):
- Level: Sample 1, Sample 2
- N: 21, 21
- Mean: 26.6, 28.8
- %CV: 2.0, 1.6
- Intra-Assay (mg/dL):
- Behring BN® Prealbumin
- Intra-Assay (mg/dL):
- N: 30
- Mean: 36.2
- %CV: 1.0
- Inter-Assay (mg/dL):
- N: 10
- Mean: 35.6
- %CV: 1.1
- Intra-Assay (mg/dL):
Lower Detection Limit
- Tina-quant® Prealbumin: 1.5 mg/dL
Method Comparison
- Tina-quant® Prealbumin vs Behring BN® Prealbumin
- Passing/Bablok: y = 1.04x + 0.1, r = 0.978, SEE = 0.9, N = 102
- Least Squares: y = 1.04x + 0.2, r = 0.978, SEE = 1.4, N = 102
- Behring BN® Prealbumin Vs NDR Parigen® Prealbumin
- Linear Regression: y = 0.84x - 0.017, SEE = 0.00, N = 40
Interfering substances
- Tina-quant® Prealbumin showed no interference (≤ 10% error) at:
- Bilirubin 60 mg/dL
- Hemoglobin 500 mg/dL
- Lipemia 1700 mg/dL
- Rheumatoid Factor 2000 IU/mL
Specificity
- Tina-quant® Prealbumin: Specific for prealbumin
- Behring BN® Prealbumin: Specific for prealbumin
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
See Summary of Performance Studies for %CV, r, and SEE values.
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.
Behring BN® Prealbumin assay
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.
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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).
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§ 866.5060 Prealbumin immunological test system.
(a)
Identification. A prealbumin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the prealbumin (a plasma protein) in serum and other body fluids. Measurement of prealbumin levels in serum may aid in the assessment of the patient's nutritional status.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 866.9.
0
Boehringer Mannheim Corporation Laboratory Diagnostics 2400 Bisso Lane PO Box 4117 Concord CA 94524-4117 ાટિપ
Telephone: +1 (510) 674 0667 Fax: +1 (510) 674 1680
JAN - 9 1998
Қ972638
Image /page/0/Picture/4 description: The image shows the logo for Boehringer Mannheim Corporation. The text is stacked in three lines, with each word in bold, uppercase letters. The first line reads "BOEHRINGER", the second line reads "MANNHEIM", and the third line reads "CORPORATION".
Image /page/0/Picture/5 description: The image is a black and white photograph. The image is mostly black, with some white spots scattered throughout. The white spots are concentrated in the center and right side of the image.
510(k) Summary
According to the requirements of 21 CFR 807.92, the following information of Introduction According to the requirements or a manage for a determination of substantial equivalence.
- Submitter name, address, contact
Boehringer Mannheim Corporation 135 Sandberg Street Thousand Oaks, CA 91360 (805) 241 - 7575
Contact Person: Mary Koning
Date Prepared: July 13, 1997
Proprietary name: Tina-quant® Prealbumin Assay
- Device name
Common name: Immunoturbidometric assay for the determination of Prealbumin.
Classification name: Prealbumin immunological test system
- Predicate device
The Boehringer Mannheim Tina-quant® Prealbumin is substantially The Documinger Manificant I in commercial distribution intended for similar use. Most notably it is substantially equivalent to the currently marketed Behring BN® Prealbumin assay.
Continued on next page
1
510(k) Summary, Continued
| 4.
Device
Description | The Prealbumin determination is based upon turbidimetric immunoinhibition
(TINIA) using a serum or plasma blood sample. The sample containing
Prealbumin is transferred into a TRIS buffer solution (R₁ reagent). In the
second step, an aliquot of solution of polyclonal anti-human Prealbumin
antibodies (R₂ reagent) is added to mixture of the first step. The antibody
binds to the Prealbumin in the sample to form "aggregates" such that the
amount of aggregate formed is proportionate to the amount of Prealbumin
present in the sample. |
|--------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | The resulting agglutination complex is measured turbidimetrically whereby
increased turbidity is reflected through an increase in optical density.
Therefore, the amount of Prealbumin in the sample is directly proportional to
the amount of turbidity formed. |
| 5.
Intended use | Immunoturbidometric assay for the quantitative in-vitro determination of
Prealbumin. |
| 6.
Comparison
to predicate
device | The Boehringer Mannheim Tina-quant® Prealbumin is substantially
equivalent to other products in commercial distribution intended for similar
use. Most notably it is substantially equivalent to the currently marketed
Behring BN® Prealbumin assay. |
| | Continued on next page |
and the same of the same of the same of the same of the same of
. .
:
2
510(k) Summary, Continued
The following table compares the Tina-quant® Prealbumin with the predicate
s of the first and the company finacific data on the performance of The following table compares the The This qualific data on the performance of
device, Behring BN® Prealbumin assay. Specific data on the performance of Comparison device, Benning BN® I realouinin assey. Spel labeling in attachment 5.
the test have been incorporated into the draphenest 6 to predicate the test have been moorporation in provided in attachment 6. device cont.
Similarities:
•Intended Use: Immunoassay for the in vitro quantitative determination of Prealbumin
·Sample type: Serum and plasma
Differences:
| Feature | Tina-quant® Prealbumin | Behring BN® Prealbumin |
|---|---|---|
| Reaction test | ||
| principle | Immunoturbidimetric | Latex bound antigen/antibody |
| causing visible agglutination | ||
| through large immune complex | ||
| formation. | ||
| Instrument | ||
| required | Hitachi | Behring Nephelometer (BN) |
Performance Characteristics:
| Feature | Tina-quant® Prealbumin | Behring BN® Prealbumin | |||
|---|---|---|---|---|---|
| Precision | Intra and InterAssay (mg/dL): | Intra and InterAssay (mg/dL): | |||
| Level | Low | Sample | High | ||
| Intra-Assay | N | 21 | 21 | 21 | 30 |
| Mean | 27.8 | 30.1 | 58.7 | 36.2 | |
| %CV | 3.6 | 3.0 | 2.4 | 1.0 | |
| Level | Sample 1 | Sample 2 | |||
| Inter-Assay | N | 21 | 21 | 10 | |
| Mean | 26.6 | 28.8 | 35.6 | ||
| %CV | 2.0 | 1.6 | 1.1 |
Continued on next page
3
510(k) Summary, Continued
Performance Characteristics:
Comparison to predicate
device, (cont.)
| Feature | Tina-quant® Prealbumin | Behring BN® Prealbumin |
|---|---|---|
| Lower Detection | ||
| Limit | 1.5 mg/dL | --- |
| Method | ||
| Comparison | Vs Behring BN® Prealbumin | |
| Passing/Bablok | ||
| $y =1.04x + 0.1$ | ||
| $r=0.978$ | ||
| $SEE =0.9$ | ||
| $N=102$ |
Least Squares:
$y = 1.04x + 0.2$
$r = 0.978$
$SEE = 1.4$
$N = 102$ | Vs NDR Parigen® Prealbumin
Linear Regression
$y =0.84x - 0.017$
$SEE =0.00$
$N=40$ |
| Interfering
substances | No interference at:
(≤ 10% error)
Bilirubin 60 mg/dL
Hemoglobin 500 mg/dL
Lipemia 1700 mg/dL
Rheumatoid
Factor 2000 IU/mL | --- |
| Specificity | Specific for prealbumin | Specific for prealbumin |
4
Food and Drug Administration 2098 Gaither Road Rockville MD 20850
JAN - 9 1998
Ms. Mary Koning Regulatory Affairs Specialist Boehringer Mannheim Corporation 135 Sandberg Street Thousand Oaks, California 91360
Re: K972638/S1 Trade Name: Tina-quant® Prealbumin Assay Regulatory Class: I Product Code: JZJ Dated: October 20, 1997 Received: October 22, 1997
Dear Ms. Koning:
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 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 requirement, 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.
5
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 ------------------
6
510(k) Number (if known): K972638
Dovicc Namc: Tina-quant® Prcalbumin Assay
Intended use
Immunological latex agglutination test for the in vitro quantitative determination of prealbumin in human serum and plasma.
Measurement of prealbumin levels in serum may aid in the assessment of the patient's nutritional status.
Concurrence of CDRH, Office of Device Evaluation (ODE)
OR
Prescription Use L (Per 21 CFR 801.109)
Over-The-Counter Use
(Optional Format 1-2-96)
Peter E. Madin