(31 days)
K 884297
COBAS-MIRA Analyzer. {510 (k) Docket No. K 851172}
No
The description details a standard turbidimetric assay and its performance characteristics, with no mention of AI or ML technologies.
No.
The device is an in vitro diagnostic assay used to detect prealbumin levels, which may aid in the assessment of nutritional status; it does not directly treat or prevent a disease or condition.
Yes
Explanation: The device is a "quantitative turbidimetric assay intended for the detection of prealbumin levels in human serum and plasma." The measurement of prealbumin levels "may aid in the assessment of an individual's nutritional status." This falls under the definition of a diagnostic device as it detects a physiological state (prealbumin levels) that aids in determining a medical condition (nutritional status).
No
The device description clearly states it is a "quantitative turbidimetric assay" and describes physical components like "assay reagents consist of a polymer diluent, a polyclonal antibody to human prealbumin, calibrators, and controls." It also mentions a "complex forms between the prealbumin, and anti-prealbumin antibodies causing turbidity" and measuring "change in optical density," all of which are physical/chemical processes and components, not solely software. The performance studies also refer to testing on an "automated system {COBAS-MIRA}", which is a hardware analyzer.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's a "quantitative turbidimetric assay intended for the detection of prealbumin levels in human serum and plasma." This involves testing samples taken from the human body (in vitro) to provide information about a physiological state (nutritional status).
- Device Description: The description details a laboratory test that uses reagents to analyze human serum and plasma samples. This is a hallmark of an in vitro diagnostic device.
- Performance Studies: The performance studies describe testing the device with human serum and plasma samples to evaluate its accuracy, precision, and comparison to a predicate device. This is typical for the validation of an IVD.
- Predicate Device: The mention of a predicate device (Incstar Antibody Reagent Set II for Prealbumin) which is also an IVD (based on its name and the context of comparison) further confirms the nature of this device.
Therefore, based on the provided information, the Prealbumin SPIA™ clearly fits the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Prealbumin SPIA™ is a quantitative turbidimetric assay intended for the detection of prealbumin levels in human serum and plasma. Measurement of prealbumin levels may aid in the assessment of an individual's nutritional status.
The use of these reagents is indicated for the measurement of prealbumin levels in human serum or plasma.
Product codes (comma separated list FDA assigned to the subject device)
DDS
Device Description
Raichem's Prealbumin SPIA ™ is a quantitative turbidimetric assay for the detection and measurement of prealbumin in human serum and plasma. The assay has been standardized to a CAP Reference Preparation. The assay reagents consist of a polymer diluent, a polyclonal antibody to human prealbumin, calibrators, and controls.
In this assay, a complex forms between the prealbumin, and anti-prealbumin antibodies causing turbidity. The change in optical density is proportional to the amount of prealbumin present. A quantitative determination of the amount of prealbumin present in a serum/plasma sample is made by comparison to a standard curve.
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)
Precision studies (Inter-assay and Intra-assay) were conducted with the Raichem's Prealbumin SPIA ™ on an automated system {COBAS-MIRA}.
Inter-assay reproducibility: Eight different serum samples were assayed ten times over six different days.
Intra-assay reproducibility: Eight serum samples were assayed 20 consecutive times in a single run.
Standardization of the Calibrators: The set of 5 calibrators supplied with the assay have been standardized within the dynamic range {0 to 55 mg/dL} using the College of American Pathologists Reference Preparation for Proteins in Human Serum, Catalog Number RM002.
Assay Sensitivity: The detection limit of the assay was determined by running multiple replicates the 0 mg/dL Calibrator and computing the mean and standard deviation. The resultant detection limit was found to be 0.9 mg/dL. {Mean + 2SD}.
Comparison Studies: The Prealbumin SPIA ™ and the Incstar Antibody Reagent Set II for Prealbumin were used to assay serum specimens from individuals being screened for prealbumin levels and apparently healthy blood donors concurrently with both devices, using an automated method {COBAS-MIRA}. A total of 134 samples were evaluated. The results indicated a high degree of linear correlation between the proposed and predicate device. The resultant linear regression relationship is: YPROPOSED = 1.06 XPREDICATE = 1.15.
Comparison of a manual method and an automated method{COBAS-MIRA}: The Raichem Prealbumin SPIA ™ was used to assay serum specimens concurrently by a manual method and an automated method {COBAS-MIRA}. A total of 30 samples were evaluated. The results indicated a high degree of linear correlation between the manual and automated methods. The resultant linear regression relationship is: VAUTOMATED = 1.10 XMANUAL + 1.07, r2 = 0.959.
Assay performance with Serum and Plasma: Twenty five (25) matched serum and EDTA-plasma samples were compared. Half of the volume of each sample was converted to serum by recalcification using a standard Ca2"/thrombin methodology. Each of the plasma and converted serum samples were evaluated with the proposed device on an automated system {COBAS-MIRA}. The results indicate that it can provide accurate estimates of prealbumin levels in both human serum and EDTA-plasma.
Interfering Substances: Lipemic, hemolytic, and icteric samples were evaluated with the assay. The results indicate that there is no significant effect ( 200 mg/dL showed significant decreases in prealbumin values.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Assay Sensitivity: The resultant detection limit was found to be 0.9 mg/dL.
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.
Incstar Antibody Reagent Set II for Prealbumin {510 (k) Docket No. K 884297}
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.
COBAS-MIRA Analyzer. {510 (k) Docket No. K 851172}
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
§ 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.
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510(k) Summary
AUG 28 1997
Submitter's Name/Contact Person 1.
Joseph M. Califano Manager, Regulatory Affairs
Address
Hemagen Diagnostics, Inc. 34-40 Bear Hill Road Waltham, MA, 02154
(617) 890-3766 Phone: (617) 890-3748 Fax: icalifano@hemagen.com email:
Date Prepared
25 July 1997
Device Name 2.
| Trade Name: | Prealbumin SPIATM |
|---|---|
| Common Name: | Prealbumin |
| Classification Name: | System, Test, immunological, prealbumin |
Predicate Device 3.
Incstar Antibody Reagent Set II for Prealbumin {510 (k) Docket No. K 884297}
За. Methods
Described in Immunoturbidimetry of transthyretin (prealbumin) in Manual method: human sera. Clin. Chem: 33: 7, 1260 1987. Ledue T.B., Rifai N, Irish, G.R., Silverman, L.M.
COBAS-MIRA Analyzer. {510 (k) Docket No. K 851172} Automated System:
100000
,
510(k) Summary Page 1
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4. Description of Device
Raichem's Prealbumin SPIA ™ is a quantitative turbidimetric assay for the detection and measurement of prealbumin in human serum and plasma. The assay has been standardized to a CAP Reference Preparation. The assay reagents consist of a polymer diluent, a polyclonal antibody to human prealbumin, calibrators, and controls.
In this assay, a complex forms between the prealbumin, and anti-prealbumin antibodies causing turbidity. The change in optical density is proportional to the amount of prealbumin present. A quantitative determination of the amount of prealbumin present in a serum/plasma sample is made by comparison to a standard curve.
5. Intended Use of Device
The Prealbumin SPIA™ is a quantitative turbidimetric assay intended for the detection of prealbumin levels in human serum and plasma. Measurement of prealbumin levels may aid in the assessment of an individual's nutritional status.
Technological Characteristics 6.(A)
Proposed Device
Raichem's Prealbumin SPIA ™ is a quantitative turbidimetric assay. This assay is performed manually following clinically accepted methodologies. The assay is designed to enable users to readily adapt it for use with automated systems such as the Roche COBAS MIRA Analyzer.
Predicate Device
Incstar's Antibody Reagent Set II for Prealbumin is also a quantitative turbidimetric assav that utilizes immunoprecipitin analysis for the determination of prealbumin levels.
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Performance Data 6.(B)
Precision .
To evaluate precision, inter-assay and intra-assay studies were conducted with the Raichem's Prealbumin SPIA ™ on an automated system {COBAS-MIRA}
A. Inter-assay reproducibility
Eight different serum samples were assayed ten times over six different days.
| SAMPLE | Mean mg/dL | Std. Dev | % CV | Mean Delta | Std. Dev | % CV |
|---|---|---|---|---|---|---|
| 1 | 36.3 | 1.9 | 5.2 | 0.272 | 0.007 | 2.7 |
| 2 | 17.1 | 1.1 | 6.6 | 0.188 | 0.007 | 3.5 |
| 3 | 7.7 | 0.4 | 5.6 | 0.115 | 0.004 | 3.3 |
| 4 | 14.1 | 0.9 | 6.4 | 0.168 | 0.006 | 3.7 |
| 5 | 22.3 | 1.1 | 4.8 | 0.217 | 0.004 | 1.9 |
| 6 | 26.3 | 1.2 | 4.7 | 0.237 | 0.004 | 1.9 |
| 7 | 36.7 | 2.5 | 6.7 | 0.273 | 0.008 | 2.9 |
| 8 | 50.4 | 2.5 | 4.9 | 0.305 | 0.007 | 2.2 |
B. Intra-assay reproducibility
The eight serum samples were also assayed 20 consecutive times in a single run.
| SAMPLE | Mean mg/dL | Std. Dev | % CV | Mean Delta | Std. Dev | % CV |
|---|---|---|---|---|---|---|
| 1 | 34.3 | 1.6 | 4.8 | 0.280 | 0.006 | 2.2 |
| 2 | 17.4 | 0.7 | 4.1 | 0.195 | 0.003 | 1.7 |
| 3 | 8.0 | 0.2 | 2.6 | 0.114 | 0.002 | 1.8 |
| 4 | 13.7 | 0.8 | 5.7 | 0.159 | 0.006 | 3.7 |
| 5 | 22.7 | 0.6 | 2.5 | 0.214 | 0.003 | 1.4 |
| 6 | 28.6 | 1.0 | 3.6 | 0.240 | 0.004 | 1.7 |
| 7 | 34.7 | 1.4 | 4.0 | 0.263 | 0.005 | 1.8 |
| 8 | 50.7 | 2.7 | 5.3 | 0.304 | 0.006 | 1.8 |
Standardization of the Calibrators 11.
The set of 5 calibrators supplied with the assay have been standardized within the dynamic range { 0 to 55 mg/dL} using the College of American Pathologists Reference Preparation for Proteins in Human Serum, Catalog Number RM002.
111. Assay Sensitivity
The detection limit of the assay was determined by running multiple replicates the 0 mg/dL Calibrator and computing the mean and standard deviation. The resultant detection limit was found to be 0.9 mg/dL. {Mean + 2SD}
510(k) Summary Page 3
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Comparison Studies IV.
- The Prealbumin SPIA ™ and the Incstar Antibody Reagent Set II for Prealbumin a. were used to assay serum specimens from individuals being screened for prealbumin levels and apparently healthy blood donors. The specimens were assayed concurrently with both the proposed and predicate devices, using an automated method {COBAS-MIRA}
A total of 134 samples were evaluated. The results indicated a high degree of linear correlation between the proposed and predicate device. The resultant linear regression relationship is:
YPROPOSED = 1.06 XPREDICATE = 1.15,
Comparison of a manual method and an automated method{COBAS-MIRA} b.
The Raichem Prealbumin SPIA ™ was used to assay serum specimens concurrently by a manual method and an automated method {COBAS-MIRA}
A total of 30 samples were evaluated. The results indicated a high degree of linear correlation between the manual and automated methods. The resultant linear regression relationship is:
VAUTOMATED = 1.10 XMANUAL + 1.07, r2 = 0.959
V Assay performance with Serum and Plasma
Twenty five (25) matched serum and EDTA-plasma samples were compared. Half of the volume of each sample was converted to serum by recalcification using a standard Ca2"/thrombin methodology. Each of the plasma and converted serum samples were evaluated with the proposed device on an automated system {COBAS-MIRA}. The results of the evaluation with the proposed device indicate that it can provide accurate estimates of prealbumin levels in both human serum and EDTA-plasma.
VI. Interfering Substances
Lipemic, hemolytic, and icteric samples were evaluated with the assay. The results indicate that there is no significant effect ( 200 mg/dL showed significant decreases in prealbumin values.
7. Conclusion
The results of the comparative studies support the claim that the Prealbumin SPIA ™ is substantially equivalent to the predicate device.
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Food and Drug Administration 2098 Gaither Road Rockville MD 20850
AUG 28 1997
Mr. Joseph M. Califano Manager, Regulatory Affairs Hemagen Diagnostics, Inc. 34-40 Bear Hill Road ... ...... Waltham, Massachusetts 02154
Re : K972812 Trade Name: Prealbumin SPIA™ Requlatory Class: I Product Code: DDS Dated: July 25, 1997 Received: July 28, 1997
Dear Mr. Califano:
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 requlation (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 requlatory 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 miqht 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) Additionally, for questions on the promotion and 594-4588. 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
Device Name:
Prealbumin SPIA ™
Indication(s) For Use
The use of these reagents is indicated for the measurement of prealbumin levels in human serum or plasma.
(PLEASE DO NOT WRITE BELOW THIS LINE)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter-Use_
Peter S. Makim
(Division Sign-Off) Division of Clinical Laboratory Devices 610(k) Number ___