(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/ML algorithms for data analysis or interpretation.
No.
This device is an in-vitro diagnostic assay used for the quantitative determination of haptoglobin, which aids in the diagnosis of certain diseases, but it does not directly treat or cure them.
Yes
The "Intended Use / Indications for Use" section explicitly states that the "Measurement of haptoglobin may aid in the diagnosis of hemolytic diseases... and certain kidney diseases." This directly indicates its diagnostic purpose.
No
The device description clearly outlines a laboratory assay that uses chemical reagents and measures optical density, indicating a hardware component (likely a spectrophotometer or similar device) is required for the measurement. It is not solely software.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The document explicitly states "Immunoturbidometric assay for the quantitative in-vitro determination of Haptoglobin" and "Immunological latex agglutination test for the in vitro quantitative determination of haptoglobin in human scrum and plasma." The phrase "in vitro" is a key indicator of an IVD.
- Device Description: The description details a test performed on a biological sample (serum or plasma blood sample) using reagents to measure a substance (Haptoglobin) within that sample. This is the core function of an IVD.
- Purpose: The intended use states that the measurement of haptoglobin "may aid in the diagnosis of hemolytic discases... and ccrtain kidncy discascs." This indicates the test is used to provide information for diagnostic purposes.
N/A
Intended Use / Indications for Use
Immunoturbidometric assay for the quantitative in-vitro determination of Haptoglobin.
Immunological latex agglutination test for the in vitro quantitative determination of haptoglobin in human scrum and plasma.
Mcasurement of haptoglobin may aid in the diagnosis of hemolytic discases in which the red blood cells rupture and release hemoglobin) related to the formation of hemoglobinhaptoglohin complexes and ccrtain kidncy discascs.
Product codes (comma separated list FDA assigned to the subject device)
DAD
Device Description
The Haptoglobin determination is based upon turbidimetric immunoinhibition (TINIA) using a serum or plasma blood sample. The sample containing Haptoglobin is transferred into a TRIS buffer solution (R₁ reagent). In the second step, an aliquot of solution of polyclonal anti-human Haptoglobin antibodies (R₂ reagent) is added to mixture of the first step. The antibody will bind to the Haptoglobin in the sample to form “aggregates” such that the amount of aggregate formed is proportionate to the amount of Haptoglobin 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 Haptoglobin 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)
Performance Characteristics:
Precision: Intra and InterAssay (ng/ml):
Level: Pool N=21, Intra-Assay Mean=167.1, %CV=2.5
Level: Low, High N=30 (for Behring BN® Haptoglobin), Intra-Assay Mean=188, %CV=2.5
Level: Sample 1, Sample 2 N=21 (for Tina-quant®), N=10 (for Behring BN®) Inter-Assay Mean=27.9 (for Sample 1, Tina-quant®), 185 (for Sample 2, Behring BN®) %CV=2.0 (for Sample 1, Tina-quant®), 3.0 (for Sample 2, Behring BN®)
Lower Detection Limit: 5 mg/dL
Linearity: 20 - 570 mg/dL
Method Comparison:
Vs Behring BN® Haptoglobin:
Deming's: y =0.998x + 2.7, r=0.982, SEE=10.97, N=98
Least Squares: y = 0.981x + 5.5, r = 0.982, SEE = 15.36, N = 98
Vs Partigen® Haptoglobin (predicate comparison):
Linear Regression: y =1.01x - 11, r=0.96, N=30
Interfering substances: No interference at: (≤ 10% error) Bilirubin 60 mg/dL, Hemoglobin 500 mg/dL, Lipemia 1500 mg/dL, Rheumatoid Factor 2000 IU/mL
Specificity: Specific for haptoglobin
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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® Haptoglobin 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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§ 866.5460 Haptoglobin immunological test system.
(a)
Identification. A haptoglobin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the haptoglobin (a protein that binds hemoglobin, the oxygen-carrying pigment in red blood cells) in serum. Measurement of haptoglobin may aid in the diagnosis of hemolytic diseases (diseases in which the red blood cells rupture and release hemoglobin) related to the formation of hemoglobin-haptoglobin complexes and certain kidney diseases.(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 § 866.9.
0
Boehringer Mannheim Corporation Laboratory Diagnostics 2400 Bisso Lane
PO Box 4117
PO Box 4117
Concord CA 94524-4117 USA
Telephone: +1 (510) 674 0667 Fax: +1 (510) 674 1680
Image /page/0/Picture/3 description: The image shows the logo for Boehringer Mannheim Corporation. The text is stacked in three lines, with each word on a separate line. The font is bold and sans-serif, and the text is black on a white background.
JAN - 9 1000
Image /page/0/Picture/5 description: The image shows a logo for Boehringer Mannheim. The logo is a black square with the word "mannheim" written vertically along the left side. Inside the square is a white circle with the word "boehringer" written inside the circle.
510(k) Summary
Introduction According to the requirements of 21 CFR 807.92, the following information provides sufficient detail to understand the basis for a determination of substantial equivalence.
| 1.
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 |
| ---------------------------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
|---|
| 2.
Device name | Proprietary name: Tina-quant® Haptoglobin Assay
Common name: Immunoturbidometric assay for the determination of Haptoglobin.
Classification name: Haptoglobin immunological test system |
| ------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
|---|
| 3.
| Predicate device | The Boehringer Mannheim Tina-quant® Haptoglobin 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® Haptoglobin assay. |
|---|---|
| ------------------------ | --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
Continued on next page
1
510(k) Summary, Continued
| 4.
Device
Description | The Haptoglobin determination is based upon turbidimetric immunoinhibition
(TINIA) using a serum or plasma blood sample. The sample containing
Haptoglobin is transferred into a TRIS buffer solution (R₁ reagent). In the
second step, an aliquot of solution of polyclonal anti-human Haptoglobin
antibodies (R₂ reagent) is added to mixture of the first step. The antibody will
bind to the Haptoglobin in the sample to form “aggregates” such that the
amount of aggregate formed is proportionate to the amount of Haptoglobin
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 Haptoglobin in the sample is directly proportional
to the amount of turbidity formed. |
|--------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 5.
Intended use | Immunoturbidometric assay for the quantitative in-vitro determination of
Haptoglobin. |
| 6.
Comparison
to predicate
device | The Boehringer Mannheim Tina-quant® Haptoglobin 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® Haptoglobin assay. |
| | Continued on next page |
2
510(k) Summary, Continued
- Comparison to predicate device cont.
The following table compares the Tina-quant® Haptoglobin with the The following table compares the Tima quain o suy. Specific data on the predicate device, Deliming DNG Traptograted into the draft labeling in performance of the test have occh moorporated in attachment 6.
Similarities:
•Intended Use: Immunoassay for the in vitro quantitative determination of Haptoglobin
•Sample type: Serum and plasma
| Differences: | ||
|---|---|---|
| Feature | Tina-quant® Haptoglobin | Behring BN® Haptoglobin |
| Reaction test | ||
| principle | Immunoturbidimetric | Latex bound antigen/antibody |
| causing visible agglutination | ||
| through large immune complex | ||
| formation. | ||
| Instrument | ||
| required | Hitachi | Behring Nephelometer (BN) |
The Co
Performance Characteristics:
| Feature | Tina-quant® Haptoglobin | Behring BN® Haptoglobin |
|---|---|---|
| Precision | Intra and InterAssay (ng/ml): | Intra and InterAssay (mg/dL): |
| Level | Pool | |
| Low | ||
| High | ||
| N | 21 | 30 |
| Intra-Assay Mean | 167.1 | 188 |
| %CV | 2.5 | 2.5 |
| Level | Sample 1 | |
| Sample 2 | ||
| N | 21 | 10 |
| Inter-Assay Mean | 27.9 | 185 |
| %CV | 2.0 | 3.0 |
| Lower Detection Limit | 5 mg/dL | --- |
Continued on next page
3
510(k) Summary, Continued
Performance Characteristics:
Comparison to predicate device, (cont.)
| Feature | Tina-quant® Haptoglobin | Behring BN®Haptoglobin |
|---|---|---|
| Linearity | 20 - 570 mg/dL | --- |
| Method | ||
| Comparison | Vs Behring BN® | |
| Haptoglobin | ||
| Deming's | ||
| $y =0.998x + 2.7$ | ||
| $r=0.982$ | ||
| $SEE=10.97$ | ||
| $N=98$ |
Least Squares:
$y = 0.981x + 5.5$
$r = 0.982$
$SEE = 15.36$
$N = 98$ | Vs Partigen® Haptoglobin
Linear Regression
$y =1.01x - 11$
$r=0.96$
$N=30$ |
| Interfering
substances | No interference at:
(≤ 10% error)
Bilirubin 60 mg/dL
Hemoglobin 500 mg/dL
Lipemia 1500 mg/dL
Rheumatoid
Factor 2000 IU/mL | --- |
| Specificity | Specific for haptoglobin | Specific for haptoglobin |
Continued on next page
4
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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 : K972639/S1 Trade Name: Tina-quant® Haptoglobin Assay Requlatory Class: II Product Code: DAD 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 Requlation (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 requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. 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 Requlations.
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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 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 requlation 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): K972639
Device Name: Tina-quant® Haptoglobin Assay
Indications For Usc:
Intendcd usc
Immunological latex agglutination test for the in vitro quantitative determination of haptoglobin in human scrum and plasma.
Mcasurement of haptoglobin may aid in the diagnosis of hemolytic discases in which the red blood cells rupture and release hemoglobin) related to the formation of hemoglobinhaptoglohin complexes and ccrtain kidncy discascs.
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | |
|---|---|
| (Per 21 CFR 801.109) |
OR
| Over-The-Counter Use | |
|---|---|
| (Optional Format 1-2-96) |
Peter E. Maksim
(Line Sign-Off) ratory Devices KA72639
(Division Sign-Off)
Division of Clinical Labor
510(k) Number