Predicate Devices

Not Found

Reference Devices

BioRad Quantaphase II® B12/Folate Assay

AI/ML (Artificial Intelligence / Machine Learning)

No
The description details a homogeneous enzyme immunoassay based on chemical reactions and spectrophotometric measurement, with no mention of AI or ML algorithms for data analysis or interpretation.

Therapeutic

No
This device is an in-vitro diagnostic assay used for the quantitative determination of folate in red blood cells, not for direct treatment or therapy.

Diagnostic

Yes

Explanation: The device is used for the "quantitation of folate in red blood cells," which provides information on a patient's biological state, serving as a diagnostic aid.

SaMD (Software as a Medical Device)

No

The device description clearly outlines a reagent pack and an assay based on enzyme activity and spectrophotometric measurement, indicating a chemical and biological process, not a software-only device.

IVD (In Vitro Diagnostic)

Yes, this device is an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use explicitly states it's for the "quantitation of folate in red blood cells." This is a measurement performed in vitro (outside the body) on a biological sample (red blood cells) to provide information about a patient's health status.
Device Description: The description details a "homogeneous enzyme immunoassay used for the quantitative determination of folate in red blood cells." Immunoassays are a common type of IVD test.
Mentions of "in-vitro": The device description explicitly uses the term "in-vitro."

These points clearly indicate that the device is designed to be used outside of the body to analyze a biological sample for diagnostic purposes, which is the definition of an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The CEDIA® Red Blood Cell Folate (No Boil) Reagent Pack to be used in combination with the CEDIA® Folate (No Boil) Assay is a homogeneous enzyme binding assay for the quantitation of folate in red blood cells.

Product codes (comma separated list FDA assigned to the subject device)

Not Found

Device Description

The CEDIA® Red Blood Cell Folate (No Boil) Reagent Pack to be used in combination with the CEDIA® Folate (No Boil) Assay is an in-vitro homogeneous enzyme immunoassay used for the quantitative determination of folate in red blood cells. The assay is based on the bacterial enzyme β-galactosidase, which has been genetically engineered into two inactive fragments. These fragments spontaneously reassociate to form fully active enzyme that, in the assay format, cleaves a substrate, generating a color change that can be measured spectrophotometrically. Folate specific binding protein, by binding to folate on the enzyme donor will inhibit enzyme reassociation thereby regulating the level of β-galactosidase formed. Folate present in the sample wil compete with the folate bound to the enzyme donor subunit for the limited number of specific binding sites further regulating the level of active enzyme formed. Concentrations of folate are directly proportional to the amount of enzyme formed as monitored by the hydrolysis of the substrate o-nitrophenyl-β-D-galactopyranoside (ONPG).

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Red blood cells (human anticoagulated whole blood)

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:
Intra-assay: Patient Samples
Level 1: 502.2 ng/mL, 5.1% CV
Level 2: 481.7 ng/mL, 4.4% CV
Level 3: 344.4 ng/mL, 6.0% CV
Level 4: 147.4 ng/mL, 8.3% CV

Method Comparison:
versus CEDIA B12/Folate Assay
Number = 96
Correlation = 0.96
Slope = 1.20
Intercept = -30.6

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.

CEDIA® Red Blood Cell Folate Reagent Pack

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.

BioRad Quantaphase II® B12/Folate Assay

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

Regulation Number and Section

§ 862.1295 Folic acid test system.

(a)
Identification. A folic acid test system is a device intended to measure the vitamin folic acid in plasma and serum. Folic acid measurements are used in the diagnosis and treatment of megaloblastic anemia, which is characterized by the presence of megaloblasts (an abnormal red blood cell series) in the bone marrow.(b)
Classification. Class II.

Summary

0

K960800

Image /page/0/Picture/1 description: The image shows the logo for Boehringer Diagnostics. The logo consists of the word "mannheim" written vertically on the left side of a black square. Inside the square is a white circle with the word "boehringer" written inside it. To the right of the logo is the word "Diagnostics" in a serif font.

July 26 1996

)

510(k) SUMMARY

| Subject: | Premarket Notification, 510(k)
CEDIA® Red Blood Cell Folate (No Boil) Reagent Pack:
Safety and Effectiveness Summary |
|------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer: | Boehringer Mannheim Corporation
2400 Bisso Lane
P.O. Box 4117
Concord CA 94524-4117
Phone 1-800-232-3342
Fax 510 674 0782

The CEDIA® Red Blood Cell Folate (No Boil) Reagent Pack to be
used in combination with the CEDIA® Folate (No Boil) Assay is an in-
vitro homogeneous enzyme immunoassay used for the quantitative
determination of folate in red blood cells. The assay is |

1

Image /page/1/Picture/0 description: The image shows the logo for Boehringer Diagnostics. The logo consists of a black square with a white circle inside, with the word "boehringer" written inside the circle and "mannheim" written vertically along the left side of the square. To the right of the logo, the word "Diagnostics" is written in a serif font.

510(k) SUMMARY cont.

ﺳﺴﺴﺴﺴ

ﻟﻤﺴﺎ

| Device Description, cont. | based on the bacterial enzyme β-galactosidase, which has been genetically engineered into two inactive fragments. These fragments spontaneously reassociate to form fully active enzyme that, in the assay format, cleaves a substrate, generating a color change that can be measured spectrophotometrically.
Folate specific binding protein, by binding to folate on the enzyme donor will inhibit enzyme reassociation thereby regulating the level of β-galactosidase formed. Folate present in the sample wil compete with the folate bound to the enzyme donor subunit for the limited number of specific binding sites further regulating the level of active enzyme formed. Concentrations of folate are directly proportional to the amount of enzyme formed as monitored by the hydrolysis of the substrate o-nitrophenyl-β-D-galactopyranoside (ONPG). | | |
|-------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------|--|
| Intended Use | The CEDIA® Red Blood Cell Folate (No Boil) Reagent Pack to be used in combination with the CEDIA® Folate (No Boil) Assay is a homogeneous enzyme binding assay for the quantitation of folate in red blood cells. | | |
| Statement of Similarities and Differences | The following table outlines the similarities and differences between the BioRad Quantaphase II B12/Folate Radioassay and CEDIA® Red Blood Cell Folate (No Boil) Reagent Pack. | | |
| Parameter | Bio-Rad Quantaphase II® B12/Folate Assay | CEDIA® Red Blood Cell Folate (No Boil) Reagent Pack | |
| Basic Principle | Competitive Protein Binding (CPB) | Competitive Protein Binding (CPB) | |
| Methodology | Radioimmunoassay | Homogeneous Enzyme Immunoassay | |
| Intended Use | Quantitative determination of Folate in human anticoagulated whole blood | Quantitative determination of Folate in human anticoagulated whole blood | |
| Monitoring System | Bound radioactivity 57Co and 125I with the pellet counted | β-galactosidase hydrolysis of ONPG | |

i

2

Image /page/2/Picture/0 description: The image shows the logo for Boehringer Diagnostics. The logo consists of the word "mannheim" written vertically on the left side of a black square. Inside the square is a circle with the word "boehringer" written inside it. To the right of the square is the word "Diagnostics".

510(k) SUMMARY, cont.

ﺮ ﻣﺴﺎ

)

..............................................................................................................................................................................

| Statement of
Similarities and

Differences, cont.
Parameter	CEDIA® Red Blood Cell
Folate Reagent Pack	CEDIA® Red Blood Cell
Folate (No Boil) Reagent Pack
Detection Mechanism	Gamma counter	Spectrophotometer at 415 nm
Reagents	Protein diluent
Ascorbic Acid	Human serum albumin based
Low calibrator (0 ng Folate/mL)
Ascorbic Acid
Sample Type	EDTA	Heparin
Working Concentration
of Ascorbic Acid	0.4%	0.2%
Protocol
Dilution
Incubation
Temperature	1:11
90 minutes
20 - 25° C	1:100
20 - 60 minutes
20 - 25° C
Stability of Ascorbic
Acid	Prepare daily.	Stable for 90 days when stored
at 2 - 8 °C
Stability of Hemolysate	Sample is stable for 10 days at
-20°C	Sample is stable for 24 hours at
-20°C
Expected Values	95 - 570 ng/mL	193 - 964 ng/mL

3

Image /page/3/Picture/0 description: The image shows the logo for Boehringer Diagnostics. The logo consists of the word "mannheim" written vertically on the left side of a black square. Inside the black square is a white circle with the word "boehringer" written inside it. To the right of the logo is the word "Diagnostics" in a serif font.

510(k) SUMMARY, cont.

ﻤﺴ

ండి మాతా శిశు సంరక్షణ ప్రాథమిక ఆరోగ్య శిశు సంరక్షణ ప్రాథమిక ఆరోగ్య ఉంది.

మూలాలు

| Statement of Similarities

and Differences, cont.
Parameter	BioRad Quantaphase II® B12/Folate Assay	CEDIA® Red Blood Cell Folate (No Boil) Reagent Pack
Precision	Intra -assay: Patient Samples	Intra -assay: Patient Samples
Level	1	2	3	1	2	3	4
Within-Run (ng/mL)
% CV	818
3.7	385
6.5	290
5.2	502.2
5.1	481.7
4.4	344.4
6.0	147.4
8.3
Method Comparison	N/A	versus CEDIA B12/Folate Assay
Number =
Correlation =
Slope =
Intercept =		96
0.96
1.20
-30.6

The performance information establishes the basis for substantial equivalence to the predicate
device.