(27 days)
BMD Alkaline Phosphatase/AMP Reagent, product no. 704093, MAS ALP Reagent, product no. 139-154
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No
The device description and performance studies focus on a chemical reagent and its performance in enzymatic assays, with no mention of AI or ML technologies.
No.
This device is a reagent used for the quantitative determination of alkaline phosphatase in serum and plasma, which is a diagnostic function, not a therapeutic one.
Yes
The "Intended Use / Indications for Use" section states that the reagent is "for the quantitative determination of alkaline phosphatase in serum and plasma" and that "The principal diagnostic indications of elevated serum alkaline phosphatase are diseases of the liver, bone, parathyroid and intestine." This directly links the determination of alkaline phosphatase to diagnostic purposes for various diseases.
No
The device is a chemical reagent intended for laboratory use, not a software program.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states it's for the "quantitative determination of alkaline phosphatase in serum and plasma." Serum and plasma are biological specimens taken from the human body.
- Diagnostic Purpose: The intended use also mentions the "principal diagnostic indications of elevated serum alkaline phosphatase are diseases of the liver, bone, parathyroid and intestine." This clearly indicates the results are used for diagnostic purposes.
- Device Description: The description details a reagent used to perform an enzymatic assay on these biological specimens.
- Performance Studies: The performance studies describe testing the reagent's effectiveness using serum and plasma samples and comparing results to other similar reagents, which is typical for IVD validation.
Therefore, based on the provided information, the HiChem ALP/AMP Reagent fits the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
HiChem ALP/AMP Reagent (product no. 70001) is intended for the quantitative determination of alkaline phosphatase in serum and plasma. The principal diagnostic indications of elevated serum alkaline phosphatase are diseases of the liver, bone, parathyroid and intestine.
Product codes (comma separated list FDA assigned to the subject device)
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Device Description
The HiChem ALP/AMP Reagent determines alkaline phosphatase by enzymatic hydrolysis of p-nitrophenylphosphate to p-nitrophenoxide at alkaline pH. The HiChem ALP/AMP Reagent is intended to be used either as a manual procedure or on clinical analyzers which can automate the required manipulations. The reagent is supplied as two liquid-stable components which are combined, either before or during use, in the approximate ratio of 1 part ALP/AMP Substrate and 5 parts ALP/AMP Reagent Buffer. The ALP/AMP Substrate can also be used as a start reagent and combined with the Reagent Buffer following sample addition.
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
Liver, bone, parathyroid and intestine.
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)
The effectiveness of the manual procedure is shown by the recovery of linearity standards, the precision of control recoveries, the comparison of serum and plasma recoveries to the MAS ALP Reagent and the validation of the chemical additives and reconstituted stability claims.
The recovery of alkaline phosphatase using HiChem ALP/AMP Reagent as a manual method at both 30°C and 37 C reaction temperatures is linear to at least 900 U/L as shown by the recovery of linearity standards ranging from 0 to over 1,350 U/L. Regression statistics are shown below.
(Recoveries at 30°C) = -1.7 U/L + 1.005 x (Standard Activity), r^2 = 0.9998, sy.x = 6.5 U/L
(Recoveries at 37°C) = 2.9 U/L + 0.969 x (Standard Activity), r^2 = 0.9998, sy.x = 8.0 U/L
Precision, demonstrated by replicate assay of control sera at 37°C, is shown below.
Serum control 1: n = 30, mean = 55 U/L, within-run SD = 2.1 U/L, total SD = 2.2 U/L
Serum control 2: n = 30, mean = 225 U/L, within-run SD = 3.7 U/L, total SD = 3.9 U/L
Serum control 3: n = 30, mean = 765 U/L, within-run SD = 6.6 U/L, total SD = 9.0 U/L
Alkaline phosphatase recoveries of 83 mixed serum and plasma specimens are compared between the HiChem and MAS reagents. Least squares regression statistics are shown below.
r^2 = 0.9986, (HiChem Results) = -0.2 U/L + 1.058 x (MAS Results) sv.x = 5.5 U/L.
The use of heparin and lithium iodoacetate as anticoagulants is shown by the assay of spiked serum pools. In all cases, the bias due to the addition of anticoagulant is less than 2% and statistically insignificant at a 95% confidence level.
The stability of the combined working reagent over 1 month at 2-8 C and 3 days at 18-25 C are documented through the recovery of serum controls which range from approximately 50 to 750 U/L AMP at 37°C. For all controls, the observed shifts in recovery were less than the greater of 3 U/L or 5%.
The effectiveness of the automated Hitachi 704 procedure is shown by the recovery of linearity standards, the precision of control recovery of serum controls over both the calibration stability period and the onboard stability claim, and the comparison of patient specimen recoveries to the BMD Alkaline Phosphatase/AMP Reagent.
The recovery of alkaline phosphatase using HiChem ALP/AMP Reagent as an automated method is linear to at least 1,200 UL as shown by the recovery of ten linearity standards which span the claimed linear range. Regression statistics are shown below.
Recoveries = 3.6 U/L + 0.98 x Standard Activity, r^2 = 1.000, sv.x = 3.6 U/L
Precision, demonstrated by replicate assay of commercially available control sera, is shown below.
Serum control 1: n = 60, mean = 49 U/L, within-run SD = 0.4 U/L, total SD = 0.6 U/L
Serum control 2: n = 60, mean = 196 U/L, within-run SD = 0.8 U/L, total SD = 1.1 U/L
Serum control 3: n = 60, mean = 692 U/L, within-run SD = 2.5 U/L, total SD = 3.0 U/L
Alkaline phosphatase recoveries of 178 mixed serum and plasma specimens compared between the HiChem and BMD reagents using least squares regression, yield the following statistics.
r^2 = 1.000, (HiChem Results) = 1.2 U/L + 1.974 x (BMD Results) sv.x = 1.4 U/L.
The 24 hour calibration stability claim is documented through the recovery of serum controls which span from approximately 50 to 750 U/L ALP. In all cases, the observed shifts in recoveries over 24 hours without calibration are less than 0.25%. The on-board stability claim of 2 weeks is documented by the recovery of serum controls using the same reagent, left on the analyzer, over 15 days. The largest observed control shift over the 15 day period was only 2%.
The HiChem ALP/AMP Reagent is shown to be safe and effective and substantially equivalent to the BMD Alkaline Phosphatase/AMP Reagent, product no. 704093, manufactured by Boehringer Mannheim Corp., Indianapolis, IN., and the MAS ALP Reagent, product no. 139-154 manufactured by Medical Analysis Systems, Inc., Camarillo, CA.
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.
BMD Alkaline Phosphatase/AMP Reagent, product no. 704093, MAS ALP Reagent, product no. 139-154
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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§ 862.1050 Alkaline phosphatase or isoenzymes test system.
(a)
Identification. An alkaline phosphatase or isoenzymes test system is a device intended to measure alkaline phosphatase or its isoenzymes (a group of enzymes with similar biological activity) in serum or plasma. Measurements of alkaline phosphatase or its isoenzymes are used in the diagnosis and treatment of liver, bone, parathyroid, and intestinal diseases.(b)
Classification. Class II.
0
/963383 SEP
DIAGNOSTICS
SUMMARY OF 510(K) SAFETY AND EFFECTIVENESS INFORMATION
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
HiChem ALP/AMP Reagent (product no. 70001) is intended for the quantitative determination of alkaline phosphatase in serum and plasma. The principal diagnostic indications of elevated serum alkaline phosphatase are diseases of the liver, bone, parathyroid and intestine.
The HiChem ALP/AMP Reagent determines alkaline phosphatase by enzymatic hydrolysis of p-nitrophenylphosphate to p-nitrophenoxide at alkaline pH. The HiChem ALP/AMP Reagent is intended to be used either as a manual procedure or on clinical analyzers which can automate the required manipulations. The reagent is supplied as two liquid-stable components which are combined, either before or during use, in the approximate ratio of 1 part ALP/AMP Substrate and 5 parts ALP/AMP Reagent Buffer. The ALP/AMP Substrate can also be used as a start reagent and combined with the Reagent Buffer following sample addition.
The HiChem ALP/AMP Reagent is substantially equivalent to the BMD Alkaline Phosphatase/AMP Reagent, product no. 704093, manufactured by Boehringer Mannheim Corp., Indianapolis, IN., and the MAS ALP Reagent, product no. 139-154 manufactured by Medical Analysis Systems, Inc., Camarillo, CA. All three reagents support the same intended use and produce equivalent results with the same clinical purpose. In addition, they are all based on the same methodology which determines alkaline phosphatase (ALP) through the measurement of liberated p-nitrophenoxide. Finally, all reagents are sold in a generic format which supplies the reagent with a manual procedure and supports its use on various instruments through procedure supplication sheets).
The effectiveness of the manual procedure is shown by the recovery of linearity standards, the precision of control recoveries, the comparison of serum and plasma recoveries to the MAS ALP Reagent and the validation of the chemical additives and reconstituted stability claims.
The recovery of alkaline phosphatase using HiChem ALP/AMP Reagent as a manual method at both 30°C and 37 C reaction temperatures is linear to at least 900 U/L as shown by the recovery of linearity standards ranging from 0 to over 1,350 U/L. Regression statistics are shown below.
| (Recoveries at 30°C) = -1.7 U/L + 1.005 x (Standard Activity), | $r^2$ = 0.9998, | sy.x = 6.5 U/L |
|---|---|---|
| (Recoveries at 37°C) = 2.9 U/L + 0.969 x (Standard Activity), | $r^2$ = 0.9998, | sy.x = 8.0 U/L |
Precision, demonstrated by replicate assay of control sera at 37°C, is shown below.
| Specimen | n | mean | within-run SD | total SD |
|---|---|---|---|---|
| Serum control 1 | 30 | 55 U/L | 2.1 U/L | 2.2 U/L |
| Serum control 2 | 30 | 225 U/L | 3.7 U/L | 3.9 U/L |
| Serum control 3 | 30 | 765 U/L | 6.6 U/L | 9.0 U/L |
Alkaline phosphatase recoveries of 83 mixed serum and plasma specimens are compared between the HiChem and MAS reagents. Least squares regression statistics are shown below.
$r^2$ = 0.9986, (HiChem Results) = -0.2 U/L + 1.058 x (MAS Results) sv.x = 5.5 U/L.
The use of heparin and lithium iodoacetate as anticoagulants is shown by the assay of spiked serum pools. In all cases, the bias due to the addition of anticoagulant is less than 2% and statistically insignificant at a 95% confidence level.
The stability of the combined working reagent over 1 month at 2-8 C and 3 days at 18-25 C are documented through the recovery of serum controls which range from approximately 50 to 750 U/L AMP at 37°C. For all controls, the observed shifts in recovery were less than the greater of 3 U/L or 5%.
The effectiveness of the automated Hitachi 704 procedure is shown by the recovery of linearity standards, the precision of control recovery of serum controls over both the calibration stability period and the onboard stability claim, and the comparison of patient specimen recoveries to the BMD Alkaline Phosphatase/AMP Reagent.
510(k) Notification, HiChem ALP/AMP Reagent Kit HiChem Diagnostics, Brea, California
23 August, 1996 Page 53 of 54
1
The recovery of alkaline phosphatase using HiChem ALP/AMP Reagent as an automated method is linear to at least 1.200 UL as shown by the recovery of ten linearity standards which span the claimed linear range. Regression statistics are shown below.
$$\text{//}\text{\'e\`e`em,\text{"Rec`ever`ies`es}\text{`es}}\text{`a``ed'`e``ed'`e} = \text{3.6```ed'`L} + \text{0.98``I} \times \text{\text{`a`et`b`e`d`e`e}}\text{`a``ed'`e}, \qquad \text{#\text{%} = \text{1.000}, \qquad \text{#\text{%} = \text{3.6``ed'de`e}}\text{\text{#\text{%} = \text{1.000}}}$$
Precision, demonstrated by replicate assay of commercially available control sera, is shown below.
| Specimen | n | mean | within-run SD | total SD |
|---|---|---|---|---|
| Serum control 1 | 60 | 49 U/L | 0.4 U/L | 0.6 U/L |
| Serum control 2 | 60 | 196 U/L | 0.8 U/L | 1.1 U/L |
| Serum control 3 | 60 | 692 U/L | 2.5 U/L | 3.0 U/L |
Alkaline phosphatase recoveries of 178 mixed serum and plasma specimens compared between the HiChem and BMD reagents using least squares regression, vield the following statistics.
$r^2$ = 1.000, (HiChem Results) = 1.2 U/L + 1.974 x (BMD Results) sv.x = 1.4 U/L.
The 24 hour calibration stability claim is documented through the recovery of serum controls which span from approximately 50 to 750 U/L ALP. In all cases, the observed shifts in recoveries over 24 hours without calibration are less than 0.25%. The on-board stability claim of 2 weeks is documented by the recovery of serum controls using the same reagent, left on the analyzer, over 15 days. The largest observed control shift over the 15 day period was only 2%.
The HiChem ALP/AMP Reagent is shown to be safe and effective and substantially equivalent to the BMD Alkaline Phosphatase/AMP Reagent, product no. 704093, manufactured by Boehringer Mannheim Corp., Indianapolis, IN., and the MAS ALP Reagent, product no. 139-154 manufactured by Medical Analysis Systems, Inc., Camarillo, CA.
Wynn Stocking
Wynh Stocking Manager of Regulatory Affairs HiChem Diagnostics