(386 days)
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No
The summary describes a quantitative immunoassay and associated automated instrument systems that perform the assay steps and calculate results. There is no mention of AI or ML in the intended use, device description, or performance studies. The calculations are described as automatic, which is typical for automated laboratory instruments and does not imply AI/ML.
No
The device is an in vitro diagnostic assay used to measure allergen-specific IgE in human serum or plasma, intended as an aid in the clinical diagnosis of IgE-mediated allergic disorders. It does not provide treatment or therapy.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states, "It is intended for in vitro diagnostic use as an aid in the clinical diagnosis of IgE mediated allergic disorders..." This directly indicates its function as a diagnostic tool.
No
The device description explicitly states that the ImmunoCAP Specific IgE reagents are used with the Phadia instrument systems (Phadia 1000, Phadia 2500, Phadia 5000), which are hardware components. The software is associated with these instruments and processes the assay steps.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The "Intended Use / Indications for Use" section explicitly states that it is an "in vitro quantitative assay" and is "intended for in vitro diagnostic use".
- Measurement in Human Samples: It measures allergen specific IgE in "human serum or plasma".
- Aid in Clinical Diagnosis: It is intended "as an aid in the clinical diagnosis of IgE mediated allergic disorders".
- Use in Clinical Laboratories: It is to be used in "clinical laboratories".
These points clearly align with the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
ImmunoCAP Specific IgE is an in vitro quantitative assay for the measurement of allergen specific IgE in human serum or plasma (EDTA or Na-Heparin). It is intended for in vitro diagnostic use as an aid in the clinical diagnosis of IgE mediated allergic disorders in conjunction with other clinical findings, and is to be used in clinical laboratories. ImmunoCAP Specific IgE is to be used with the instruments Phadia 1000, Phadia 2500 and Phadia 5000.
Product codes (comma separated list FDA assigned to the subject device)
DHB
Device Description
ImmunoCAP Specific IgE reagents are modular in concept and are available individually. For a complete listing of reagents needed to perform the Phadia ImmunoCAP Specific IgE assay, please consult the ImmunoCAP Specific IgE Conjugate Directions for Use.
Phadia 250, Phadia 1000, Phadia 2500 and Phadia 5000 instrument systems, and associated software, processes all steps of the assay and calculates results automatically after the assay is completed. Analytical and clinical validation of these components were performed on the representative instrument Phadia 250 and Phadia 1000.
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
clinical laboratories
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/Reproducibility:
- Within-laboratory imprecision: Evaluated by testing five (f433, rTri a 14) or six (f416, rTri a 19 and f449, rSes i 1) positive samples per component, in four replicates per day over 20 operating days (80 replicates total per sample, except for one sample with 33 replicates). Mean concentrations, standard deviation (SD), and coefficients of variance (%CV) were calculated.
- Lot-to-lot imprecision: Three different lots of each ImmunoCAP Allergen Component were tested using four (f433, rTri a 14 and f416, rTri a 19) or five (f449, rSes i 1) positive samples and one negative sample ( 50% inhibition. All results met specifications, verifying analytical specificity.
Interference: Evaluated if icteric, haemolytic, lipemic samples, or samples containing Rheumatoid Factor adversely affect results. Three samples (two positive, one negative) were spiked with Bilirubin F, Bilirubin C, Chyle, Hemoglobin, and Rheumatoid Factor. The results demonstrated no adverse effect from icteric, hemolytic, or lipemic samples, or Rheumatoid Factor at tested concentrations.
Stability studies: Performed in accordance with CLSI EP25-A using three lots of each component.
- f416, rTri a 19 Omega-5 Gliadin, Wheat; f433, rTri a 14 LTP, Wheat: Met specifications, showed 19 months unopened shelf-life stability.
- f449, rSes i 1: Real-time stability data supports 6 months unopened shelf-life stability; accelerated stability study with two positive and one negative samples and three lots also supports this claim. Real-time study ongoing.
Method Comparison study:
- Compared ImmunoCAP Allergen components to corresponding extract-based ImmunoCAP Allergen (predicate device).
- Samples (N=43-62) included:
- (i) individuals with clinical history of allergy-like symptoms (32-33 positive clinical samples)
- (ii) sensitized individuals without documented clinical history (10-30 positive non-clinical samples)
- (iii) healthy non-atopic donors (100 negative samples).
- Result: Undetectable specific IgE ( 0.1 kUx/L demonstrated in 32/32 clinical samples and 30/30 non-clinical samples when compared to ImmunoCAP Allergen f10, Sesame seed.
Clinical studies (Clinical sensitivity and specificity):
- Compared component performance to clinical diagnosis of allergy.
- Samples: Individuals with clinical history of allergy-like symptoms (diagnosed by physician) and healthy non-atopic subjects (n=100).
- Test results ≥0.35 kUA/L considered positive.
- f433, rTri a 14 LTP, Wheat:
- Sensitivity = 19 % (25/133) 95% CI: 12.5%-26.5%
- Specificity = 100% (100/100) 95% CI: 96.4%-100%
- f416, rTri a 19 Omega-5 Gliadin, Wheat:
- Sensitivity = 32 % (41/129) 95% CI: 23.9 - 40.6%
- Specificity = 100% (100/100) 95% CI: 96.4%-100%
- f449, rSes i 1, Sesame Seed:
- Sensitivity = 80% (28/35) 95% CI: 63.1 - 91.6%
- Specificity = 100% (100/100) 95% CI: 96.4%-100%
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- f433, rTri a 14 LTP, Wheat:
- Sensitivity = 19 % (25/133) 95% CI: 12.5%-26.5%
- Specificity =100% (100/100) 95% CI: 96.4%-100%
- f416, rTri a 19 Omega-5 Gliadin, Wheat:
- Sensitivity = 32 % (41/129) 95% CI: 23.9 - 40.6%
- Specificity = 100% (100/100) 95% CI: 96.4%-100%
- f449, rSes i 1, Sesame Seed:
- Sensitivity = 80% (28/35) 95% CI: 63.1 - 91.6%
- Specificity =100% (100/100) 95% CI: 96.4%-100%
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.
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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§ 866.5750 Radioallergosorbent (RAST) immunological test system.
(a)
Identification. A radioallergosorbent immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the allergen antibodies (antibodies which cause an allergic reaction) specific for a given allergen. Measurement of specific allergen antibodies may aid in the diagnosis of asthma, allergies, and other pulmonary disorders.(b)
Classification. Class II (special controls). The device, when intended to detect any of the allergens included in Table 1 in this paragraph, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 866.9. Table 1—Class II Exempt Allergens Under § 866.5750—Radioallergosorbent (RAST) Immunological Test Systems
Allergen code Allergen product Source (taxonomical name) Grass Pollens g1 Sweet vernal grass Anthoxanthum odoratum. g3 Cocksfoot grass, Orchard grass Dactylis glomerata. g4 Meadow fescue Festuca elatior. g5 Rye-grass (perennial rye grass) Lolium perenne. g7 Common reed (common reed grass) Phragmites communis. g8 Meadow grass, Kentucky blue (June grass) Poa pratensis. g9 Redtop, Bentgrass Agrostis stolonifera ,Agrostis gigantea (Agrostis alba ). g11 Brome grass Bromus inermis. g12 Cultivated rye (cultivated rye grass) Secale cereale. g13 Velvet grass Holcus lanatus. g14 Cultivated oat (cultivated oat grass) Avena sativa. g15 Cultivated wheat (cultivated wheat grass) Triticum aestivum (Triticum spp.). g16 Meadow foxtail (meadow foxtail grass) Alopecurus pratensis. g17 Bahia grass Paspalum notatum. g24 Wheat grass, Western Agropyron smithii (Elymus smithii ). g30 Bluegrass, annual Poa annua. g70 Wild rye grass Elymus triticoides Elymus condensatus. g71 Canary grass Phalaris arundinacea. g201 Barley, cultivated Hordeum vulgare. g202 Maize, corn (cultivated corn) Zea mays. g203 Salt grass Distichlis spicata. g204 False oat-grass Arrhenatherum elatius. g216 Cyn d 1 Cynodon dactylon. g701 Phl p 1.0102, Phl p 5.0101 Phleum pratense. g702 Phl p 7.0101 Phleum pratense. g703 Phl p 12.0101 Phleum pratense. Weed Pollens w2 Western ragweed Ambrosia psilostachya. w4 False ragweed Ambrosia acanthicarpa (Franseria acanthicarpa ). w5 Wormwood Artemisia absinthium Artemisia annua. w6 Mugwort Artemisia vulgaris. w7 Marguerite, ox-eye daisy Chrysanthemum leucanthemum. w8 Dandelion Taraxacum vulgare ,Taraxacum officinale. w9 Plantain (English), Ribwort Plantago lanceolata. w10 Goosefoot, lamb's quarters Chenopodium album. w11 Saltwort (prickly), Russian thistle Salsola kali (Salsola pestifer ). w12 Goldenrod Solidago virgaurea (Solidago spp.). w13 Cocklebur, common Xanthium commune. w14 Common pigweed (rough pigweed) Amaranthus retroflexus. w15 Scale, Lenscale Atriplex lentiformis. w16 Rough marsh elder Iva ciliate ,Iva annua. w17 Firebush (Kochia) Kochia scoparia. w18 Sheep sorrel Rumex acetosella. w19 Wall pellitory Parietaria officinalis. w20 Nettle (Common stinging nettle) Urtica dioica. w21 Wall pellitory Parietaria judaica. w22 Japanese hop (careless weed) Humulus japonicas (Humulus scandens ). w23 Yellow dock, Yellow dockweed Rumex crispus. w24 Spiny pigweed Amaranthus spinosus. w27 Carnation Dianthus spp. w28 Rose Rosa rugosa. w33 Clover Trifolium pratense. w35 Mexican tea Chenopodium ambrosioides. w36 Rabbit bush Ambrosia deltoidea (Franseria deltoides ). w37 Salt bush, annual Atriplex wrightii. w39 Water hemp, Western Amaranthus rudis (Acnida tamariscina ). w41 Burrobrush Hymenoclea salsola. w42 Poverty weed Baccharis neglecta. w43 Common sagebrush Artemisia tridentata. w45 Alfalfa Medicago sativa. w46 Dog fennel Eupatorium capillifolium. w53 Geranium Geranium spp. w67 Groundsel bush Baccharis halimifolia. w69 Iodine bush Allenrolfea occidentalis. w70 Ragweed, slender Ambrosia confertiflora. w75 Wing scale (wingscale) Atriplex canescens. w82 Careless weed Amaranthus palmeri ,Amaranthus hybridus. w90 Japanese hop Humulus japonicas (Humulus scandens ). w203 Rape (rape pollen) Brassica napus. w204 Sunflower Helianthus annuus. w206 Camomile Matricaria chamomilla. w207 Lupin Lupinus spp. w210 Sugar-beet Beta vulgaris. w211 Par j 2.0101 Parietaria judaica. w231 Art v 1 Artemisia vulgaris (Mugwort). w232 Sal k 1 Salsola kali. w233 Art v 3 Artemisa vulgaris (LTP, Mugwort). w234 Pla l 1 Plantago lanceolata. w235 Che a 1.0101 Chenopodium album. w236 Mer a 1.0101 Mercurialis annua. a753 Art v 1 Artemisia vulgaris (Mugwort weed). Tree Pollens t1 Box-elder (Maple) Acer negundo ,Acer saccharum. t2 Gray alder, speckled alder (alder) Alnus incana. t4 Hazel, hazelnut Corylus avellana ,Corylus americana. t5 American beech (beech) Fagus grandifolia (Fagus americana ). t6 Mountain juniper, Mountain cedar Juniperus ashei (Juniperus sabinoides ). t8 Elm Ulmus americana. t9 Olive Olea europaea. t10 Walnut Juglans californica ,Juglans nigra. t11 Maple leaf sycamore, London plane, Plane tree Platanus acerifolia. t61 Sycamore Platanus occidentalis. t12 Willow Salix caprea ,Salix nigra. t14 Cottonwood (Eastern Cottonwood/Black Cottonwood) Populus deltoides. t15 White ash Fraxinus americana. t16 White pine Pinus strobus. t18 Eucalyptus, gum-tree Eucalyptus globulus (Eucalyptus spp.). t19/t26 Acacia Acacia longifolia (Acacia spp.). t20 Mesquite Prosopis glandulosa/ Prosopis juliflora. t21 Melaleuca, cajeput tree Melaleuca quinquenervia (Melaleuca leucadendron ). t22 Pecan, hickory Carya illinoinensis (Carya pecan ). t23 Italian/Mediterranean/funeral cypress Cupressus sempervirens. t24 Japanese cypress Chamaecyparis obtusa (Chamaecyparis spp.). t25 Ash Fraxinus excelsior. t27 Maple, red Acer rubrum. t29 Acacia Acacia spp. t30 Birch, white Betula populifolia. t32 Willow, black Salix nigra. t33 Ash, Arizona Fraxinus velutina. t35 Cedar, salt Tamarix gallica. t37 Bald cypress (white bald cypress) Taxodium distichum. t38 Elm, Chinese/Siberian Ulmus pumila. t40 Hazelnut tree Corylus americana. t41 White hickory Carya alba (Carya tomentosa ). t42 Oak, red Quercus rubra. t43 Loblolly pine Pinus taeda. t44 Hackberry Celtis occidentalis. t45 Cedar elm Ulmus crassifolia. t47 Juniper, one seed Juniperus monosperma. t48 Pine, lodgepole Pinus contorta. t49 Pine, ponderosa Pinus ponderosa. t50 Beech, European Fagus sylvatica. t51 Tree of Heaven Ailanthus altissima. t52 Western white pine Pinus monticola. t54 Russian olive Elaeagnus angustifolia. t55 Scotch broom Cytisus scoparius. t56 Bayberry Myrica cerifera. t57 Red cedar Juniperus virginiana. t60 Western juniper Juniperus occidentalis. t61 Sycamore Platanus occidentalis. t70 Mulberry (white mulberry) Morus alba. t71 Red mulberry Morus rubra. t72 Queen palm Arecastrum romanzoffiamon. t73 Australian pine Casuarina equisetifolia. t77 Oak mix (red, white, black) Quercus spp. t80 Japanese cypress Chamaecyparis obtusa. t81 Japanese alder Alnus japonica. t83 Mango tree Mangifera indica. t90 Walnut, black Juglans nigra. t96 Poplar, white (poplar) Populus alba. t103/t218 Virginia live oak (live oak) Quercus virginiana. t105 Pepper tree Schinus molle. t110 Orange tree Citrus sinensis. t201 Spruce, Norway spruce Picea abies (Picea excelsa ). t202 Alder, smooth Alnus incana spp.Rugosa (Alnus rugosa ). t203 Horse chestnut Aesculus hippocastanum. t205 Elder Sambucus nigra. t206 Chestnut Castanea sativa. t207 Douglas fir Pseudotsuga menziesii (Pseudotsuga taxifolia ). t208 Linden Tilia cordata. t209 Horn beam Carpinus betulus. t210 Privet Ligustrum vulgare. t211 Sweet gum Liquidambar styraciflua. t212 Cedar Libocedrus decurrens. t213 Pine Pinus radiata. t214 Date palm Phoenix canariensis. t215 Lilac Syringa vulgaris. t217 Pepper tree Schinus molle. t217 Red alder Alnus rubra. t218 Virginia live oak Quercus virginiana. t218 Bayberry (bayberry/sweet gale) Myrica gale. t219 Palo verde Cercidium floridum. t219 Red cedar Juniperus virginiana. t220 Bet v 4 Betula verrucosa (Birch). t221 Bet v 2.0101, Bet v 4 Betula verrucosa (Birch). t222 Cypress (Arizona cypress) Cupressus arizonica. t223 Oil palm Elaeis guineensis. t224 Ole e 1 Olea europaea. t225 Bet v 6 Betula verrucosa (Birch). t226 Cup a 1 Cupressus arizonica. t227 Ole e 7 Olea Europaea. t228 Aspen, quaking Populus tremuloides. t229 Eastern hemlock Tsuga canadensis. t230 Redwood (sequoia) Sequoia sempervirens. t232 Pussy willow Salix discolor. t240 Ole e 9.0101 Olea Europaea. t241 Pla a 1.0101 Platanus acerifolia. t242 Pla a 2 Platanus acerifolia. t243 Pla a 3.0101 Platanus acerifolia. t244 Cor a 1.0103 Corylus avellana. t245 Aln g 1.0101 Alnus glutinosa. t246 Cry j 1 Cryptomeria japonica. t280 Locust tree Robinia pseudoacacia. t401 Brazilian peppertree Schinus terebinthifolius. t402 Mastic tree Pistacia lentiscus. t404 Tree of heaven Ailanthus altissima. t406 Date palm Phoenix dactylifera. a482 Ole e 1 Olea europaea (Olive Oil). Mites d207 Blo t 5.0101 Blomia tropicalis. d208 Lep d 2.0101 Lepidoglyphus destructor. Microorganisms, Molds, Yeast m1 Penicillium chrysogenum (Penicillium notatum ) Penicillium chrysogenum (Penicillium notatum ). m2 Cladosporium herbarum (Hormodendrum ) Cladosporium herbarum (Hormodendrum ). m3 Aspergillus fumigatus Aspergillus fumigatus. m4 Mucor racemosus Mucor racemosus. m5 Candida albicans Candida albicans. m7 Botrytis cinerea Botrytis cinerea. m8 Drechslera halodes (Setomelanomma rostrata, Helminthosporium halodes, Helminthosporium interseminatum ) Drechslera halodes (Setomelanomma rostrata, Helminthosporium halodes. m9 Fusarium moniliforme (Fusarium proliferatum ) Fusarium moniliforme (Fusarium proliferatum ). m10 Stemphylium botryosum Stemphylium herbarum (Stemphylium botryosum ). m11 Rhizopus nigricans Rhizopus nigricans. m12 Aureobasidium pullulans Aureobasidium pullulans. m13 Phoma betae Phoma betae. m14 Epicoccum purpurascens Epicoccum purpurascens (Epicoccum nigrum ). m15 Trichoderma viride Trichoderma viride. m16 Curvularia lunata Curvularia lunata ,Curvularia specifera (K923044 ). m17 Cladosporium fulvum Cladosporium fulvum. m18 Fusarium culmorum Fusarium culmorum. m19 Aspergillus versicolor Aspergillus versicolor. m20 Mucor mucedo Mucor mucedo. m21 Aspergillus clavatus Aspergillus clavatus. m22 Micropolyspora faeni Saccharopolyspora rectivirgula (Micropolyspora faeni ). m23 Thermoactinomyces vulgaris Thermoactinomyces vulgaris. m24 Stachybotrys atra Stachybotrys chartarum (Stachybotrys atra ). m24 Paecilomyces spp Paecilomyces spp. m25 Aspergillus versicolor Aspergillus versicolor. m25 Penicillium brevicompactum Penicillium brevicompactum. m26 Cladosporium cladosporioides Cladosporium cladosporioides. m26 Penicillium citrinum Penicillium citrinum. m27 Penicillium spp Penicillium spp. m29 Aspergillus repens Aspergillus repens. m30 Penicillium roqueforti Penicillium roqueforti. m32 Cladosporium cladosporioides Cladosporium cladosporioides. m34 Serpula lacrymans Serpula lacrymans. m36 Aspergillus terreus Aspergillus terreus. m37 Trichophyton mentagrophytes Trichophyton mentagrophytes. m40 Aspergillus amstelodami Aspergillus amstelodami. m43 Saccharomyces Carlsberg Saccharomyces carlsbergensis. m44 Saccharomyces cerevisiae Saccharomyces cerevisiae. m45 Hormodendrum hordei Hormodendrum hordei. m46 Bipolaris spicifera Bipolaris spicifera. m47 Aspergillus nidulans Aspergillus nidulans. m48 Aspergillus oryzae Aspergillus oryzae. m49 Fusarium oxysporum Fusarium oxysporum. m50 Micropolyspora faeni Saccharopolyspora rectivirgula (Micropolyspora faeni ). m51 Thermoactinomyces vulgaris Thermoactinomyces vulgaris. m53 Microspora canis Microsporum canis (Microspora canis ). m54 Aspergillus flavus Aspergillus flavus. m63 Helminthosporium intersemin Helminthosporium intersemin. m66 Mucor plumbeus Mucor plumbeus. m67 Mycogone Mycogone perniciosa. m68 Nigrospora oryzae Nigrospora oryzae. m69 Rhodotorula Rhodotorula rubra (Rhodotorula mucilaginosa ). m70 Malassezia furfur (Pityrosporum orbiculare ) Malassezia furfur (Pityrosporum orbiculare ). m71 Spondylocladium Spondylocladium spp. m72 Epidermophyton Epidermophyton floccosum. m73 Epicoccum nigrum Epicoccum purpurascens (Epicoccum nigrum ). m80 Staphylococcal enterotoxin A (Sta a SEA ) Staphylococcus aureus. m80 Helminthosporium spp Helminthosporium spp. m81 Staphylococcal enterotoxin B (Sta a SEB ) Staphylococcus aureus. m88 Stemphylium solani Stemphylium solani. m93 Gliocladium fimbriatum Gliocladium fimbriatum. m94 Phycomyces blakesleeanus Phycomyces blakesleeanus. m201 Tilletia tritici (Ustilago nuda, Ustilago tritici ) (Barley smut) Tilletia tritici (Ustilago nuda, Ustilago tritici ). m202 Acremonium kiliense (Cephalosporium acremonium ) Acremonium kiliense (Cephalosporium acremonium ). m203 Trichosporon pullulans Trichosporon pullulans. m204 Ulocladium chartarum Ulocladium chartarum. m205 Trichophyton rubrum Trichophyton rubrum. m207 Aspergillus niger Aspergillus niger. m208 Chaetomium globosum Chaetomium globosum. m209 Penicillium frequentans Penicillium glabrum (Penicillium frequentans ). m209 Stachybotrys chartarum Stachybotrys chartarum (Stachybotrys atra ). m210 Trichophyton mentagrophytes var. goetzii Trichophyton mentagrophytes var. goetzii. m211 Trichophyton mentagrophytes var. interdigitale Trichophyton mentagrophytes var. interdigitale. m211 Oat smut Ustilago avenae. m212 Micropolyspora faeni Saccharopolyspora rectivirgula (Micropolyspora faeni ). m212 Geotrichum candidum Geotrichum candidum. m213 Bermuda grass smut Ustilago cynodontis. m214 Johnson grass smut Sphacelotheca cruenta. m215 Corn smut Ustilago maydis. m218 Asp f 1.0101 Aspergillus fumigatus. a3050 Asp r 1 Aspergillus restrictus. m219 Asp f 2 Aspergillus fumigatus. m220 Asp f 3.0101 Aspergillus fumigatus. m221 Asp f 4 Aspergillus fumigatus. m222 Asp f 6.0101 Aspergillus fumigatus. m223 Staphylococcal enterotoxin C (Sta a SEC ) Staphylococcus aureus. m224 Staphylococcal enterotoxin D (Sta a SED ) Staphylococcus aureus. m226 Staphylococcal enterotoxin TSST (Sta a TSST ) Staphylococcus aureus. m227 Malassezia spp. (Pityrosporum spp.) Malassezia spp. (Pityrosporum spp.). m228 Aspergillus flavus. m229 Alt a 1.0101 Alternaria alternata (Alternaria tenuis ). m230 Alt a 6.0101 Alternaria alternata (Alternaria tenuis ). m231 Cla h 8.0101 Cladosporium herbarum (Hormodendrum ). m300 Eurotium spp Eurotium spp. m304 Aspergillus oryzae Aspergillus oryzae. m305 Penicillium brevicompactum Penicillium brevicompactum. m309 Aspergillus terreus Aspergillus terreus. m310 Aspergillus nidulans Aspergillus nidulans. m311 Aspergillus flavus Aspergillus flavus. m312 Aspergillus clavatus Aspergillus clavatus. Epidermal & Animal e6 Guinea pig epithelium Cavia porcellus. e7 Pigeon droppings Columba palumbus ,Columba livia. e25 Chicken serum Gallus domesticus (Gallus gallus domesticus; Gallus spp.). e26 Parrot serum Psittacoidea spp. e62 Camel Camelus dromedaries. e70 Goose feathers Anser anser. e71 Mouse epithelium Mus musculus (Mus spp.). e73 Rat epithelium Rattus norvegicus. e74 Rat urine proteins Rattus norvegicus ,Rattus rattus. e75 Rat serum proteins Rattus norvegicus ,Rattus rattus. e76 Mouse serum proteins Mus musculus (Mus spp.). e77 Budgerigar droppings Melopsittacus undulatus. e78 Budgerigar feathers Melopsittacus undulatus. e79 Budgerigar serum proteins Melopsittacus undulatus. e80 Goat epithelium Capra hircus. e81 Sheep epithelium Ovis aries (Ovis spp.). e82 Rabbit epithelium Oryctolagus cuniculus (Oryctolagus spp.). e83 Swine epithelium Sus scrofa (Sus scrofa domesticus; Sus spp.). e84 Hamster epithelium Cricetus cricetus, Mesocricetus auratus, and Phodopus sungorus. e85 Chicken feathers Gallus domesticus (Gallus gallus domesticus; Gallus spp.). e86 Duck feathers Anas platyrhynchos. e87 Rat epithelium, serum proteins, and urine proteins Rattus norvegicus Rattus rattus. e88 Mouse epithelium, serum proteins, and urine proteins (mouse) Mus musculus (Mus spp.). e89 Turkey feathers Meleagris gallopavo. e90 Budgerigar serum proteins, feathers, and droppings Melopsittacus undulatus. e91 Pigeon serum proteins, feathers, and droppings Streptopelia roseogrisea ,Psittacidae spp. e92 Parrot serum proteins, feathers, and droppings Ara spp. e93 Pigeon serum proteins Streptopelia roseogrisea. e94 Fel d 1.0101 Felis domesticus. a345 Fel d 1 Felis domesticus. e98 Parrot droppings Psittacoidea spp. e101 Can f 1.0101 Canis familiaris (Canis domesticus ). a174 Can f 1 Canis familiaris (Canis domesticus ). e102 Can f 2.0101 Canis familiaris (Canis domesticus ). e196 Parakeet feathers Nymphicus hollandicus. e197 Parakeet droppings Nymphicus hollandicus. e198 Parakeet serum Nymphicus hollandicus. e199 Canary bird serum Serinus canarius. e200 Canary bird droppings Serinus canarius. e201 Canary bird feathers (Canary feathers) Serinus canarius. e202 Reindeer epithelium Rangifer tarandus. e203 Mink epithelium Mustela spp. e204 Bos d 6 Bos domesticus (Bos taurus; Bos spp.). e205 Horse, serum proteins Equus caballus (Equus spp.). e206 Rabbit, serum proteins Oryctolagus cuniculus (Oryctolagus spp.). e208 Chinchilla epithelium Chinchilla laniger. e209 Gerbil epithelium Meriones unguiculatus. e210 Fox epithelium Vulpes vulpes. e211 Rabbit, urine proteins Oryctolagus cuniculus (Oryctolagus spp.). e212 Swine, urine proteins Sus scrofa (Sus scrofa domesticus; Sus spp.). e213 Parrot feathers Ara spp. e214 Finch feathers Lonchura domestica. e215 Pigeon feathers Streptopelia roseogrisea (Streptopelia spp.),Columbia spp. e216 Deer epithelium Dama dama. e217 Ferret epithelium Mustela putorius. e218 Chicken droppings Gallus domesticus (Gallus gallus domesticus; Gallus spp.). e219 Chicken, serum proteins Gallus domesticus (Gallus gallus domesticus; Gallus spp.). e220 Fel d 2, Cat serum albumin Felis domesticus. e221 Can f 3 Canis familiaris (Canis domesticus ) (Dog serum albumin ). e222 Swine serum albumin (Sus s PSA) Sus scrofa (Sus scrofa domesticus; Sus spp.). e225 Lovebird feathers Psittacoidea agapomis. e226 Can f 5.0101 Canis familiaris. e227 Equ c 1.0101 Equus caballus. e228 Fel d 4.0101 Felis domesticus. e230 Equ c 3 Equus caballus. e231 Mus m 1 Mus musculus. Food f9 Rice Oryza sativa. f12 Pea (green pea) Pisum sativum. f15 White bean Phaseolus vulgaris. f19 Cayenne pepper Capsicum frutescens (Capsicum annum ). f21 Sugar cane Saccharum officinarum. f22 Raspberry Rubus idaeus. f26 Pork Sus scrofa (Sus scrofa domesticus; Sus spp.). f29 Watermelon Citrullus lanatus (Citrullus vulgaris ). f31 Carrot Daucus carota. f32 Oyster mushroom Pleurotus ostreatus. f33 Orange Citrus sinensis. f35 Potato Solanum tuberosum. f43 Mother's milk Homo sapiens. f44 Strawberry Fragaria vesca (Fragaria spp.). f45 Yeast, baker's Saccharomyces cerevisiae. f46 Pepper, Red Capsicum annuum. f47 Garlic Allium sativum. f48 Onion Allium cepa. f49 Apple Malus x domestica (Malus spp.). f51 Bamboo shoot Phyllostachys pubescens. f52 Cacao/chocolate Theobroma cacao. f54 Sweet potato Ipomoea batatas. f55 Common millet Panicum miliaceum. f56 Foxtail millet Setaria italica. f57 Japanese millet Echinochloa crus-galli. f58 Pacific squid Todarodes pacificus. f59 Octopus Octopus vulgaris (Octopus spp.). f63 Kefir NA. f67 Parmesan cheese NA. f81 Cheese, cheddar type NA. f82 Cheese, mold type NA. f83 Chicken Gallus domesticus (Gallus gallus domesticus; Gallus spp.). f86 Parsley Petroselinum crispum. f87 Melon Cucumis melo Cucumis melo + Citrullus lanatus. f88 Mutton (lamb) Ovis aries (Ovis spp.). f90 Malt Hordeum vulgare. f92 Banana Musa spp. f93 Cacao Theobroma cacao. f94 Pear Pyrus communis (Pyrus spp.). f97 Yam Dioscorea spp.Dioscorea opposita. f97 Chamomile tea Matricaria chamomilla. f98 Gliadin Triticum aestivum (Triticum spp.). f102 Cantaloupe Cucumis melo var. cantalupensis. f105 Chocolate Theobroma cacao. f109 Cottonseed Gossypium hirsutum. f110 Giant radish Raphanus sativus. f118 Zucchini Cucurbita pepo. f119 Radish Raphanus sativus. f120 Venison Capreolus capeolus. f121 Pinto bean Phaseolus vulgaris. f122 Cheese, American NA. f127 Black-eyed pea Vigna unguiculata. f131 Black Olive Olea europaea. f136 Red beet Beta vulgaris var. conditiva. f139 Goat's Cheese Capra aegagrus. f140 Bran NA. f141 Corn (vegetables) Zea mays. f152 Green bell pepper Capsicum annuum. f155 Brewer's yeast Saccharomyces carlsbergensis. f157 Duck Anas domesticus. f158 Goose Anser anser. f160 Camembert cheese NA. f162 Nectarine Prunus persica var. nucipersica. f163 Kohlrabi Brassica oleracea var. gongylodes. f65 Perch f166 Leek Allium porrum. f170 Cheese (Switzerland) (Swiss cheese) NA. f174 Fig Ficus carica. f177 Cranberry Vaccinium macrocarpon. f179 Raisin Vitis spp. f182 Lima bean Phaseolus lunatus. f198 Flaxseed (bruised grain) Linum usitatissimum. f199 Untreated native milk Bos domesticus (Bos taurus; Bos spp.). f208 Lemon Citrus limon. f209 Grapefruit Citrus paradisi. f210 Pineapple Ananas comosus. f211 Blackberry Rubus fruticosus. f212 Mushroom (champignon) Agaricus hortensis (Agaricus spp.). f213 Rabbit Oryctolagus cuniculus (Oryctolagus spp.). f214 Spinach Spinacia oleracea. f215 Lettuce Lactuca sativa. f216 Cabbage Brassica oleracea var. capitata. f217 Brussels sprouts Brassica oleracea var. gem. f218 Paprika, sweet pepper Capsicum annuum. f219 Fennel seed Foeniculum vulgare. f219 Sage Salvia officinalis. f220 Cinnamon Cinnamomum spp. f221 Coffee Coffea spp. f222 Tea Camellia sinensis. f223 Green olive Olea europaea. f225 Summer squash, pumpkin Cucurbita pepo. f225 Pumpkin Cucurbita maxima. f226 Pumpkin seed Cucurbita pepo. f227 Sugar-beet seed Beta vulgaris. f229 Safflower Seed Carthamus tinctorius. f231 Milk, boiled Bos domesticus (Bos taurus; Bos spp.). f234 Vanilla Vanilla planifolia. f237 Apricot Prunus armeniaca. f241 Gouda cheese NA. f242 Cherry Prunus avium. f244 Cucumber Cucumis sativus. f246 Guar, guar gum Cyamopsis tetragonoloba. f247 Honey NA. f248 Rosemary Rosmarinus officinalis. f254 Plaice Pleuronectes platessa. f255 Plum Prunus domestica ,Prunus americana. f258 Squid Loligo spp. f259 Grape Vitis vinifera (Vitis spp.). f260 Broccoli Brassica oleracea var. italica (Brassica oleracea var. cultivar ). f261 Asparagus Asparagus officinalis. f262 Aubergine, eggplant Solanum melongena. f263 Green pepper Piper nigrum ,Capsicum annuum. f264 Eel Anguilla anguilla. f265 Caraway Carum carvi. f265 Cumin Cuminum cyminum. f266 Mace Myristica fragrans. f267 Cardamon Elettaria cardamomum. f268 Clove Syzygium aromaticum. f269 Basil Ocimum basilicum. f270 Ginger Zingiber officinale. f271 Anise Pimpinella anisum. f272 Tarragon Artemisia dracunculus. f273 Thyme Thymus vulgaris. f274 Marjoram Origanum majorana. f275 Lovage Levisticum officinale. f276 Fennel, fresh Foeniculum vulgare. f277 Dill Anethum graveolens. f278 Bay leaf Laurus nobilis. f279 Chili pepper Capsicum frutescens. f280 Black pepper Piper nigrum. f281 Curry (Santa Maria) NA. f282 Nutmeg Myristica fragrans. f283 Oregano Origanum vulgare. f284 Turkey meat Meleagris gallopavo. f285 Elk/moose meat Alces spp. f286 Mare's milk Equus caballus (Equus spp.). f287 Red kidney bean Phaseolus vulgaris. f288 Blueberry Vaccinium myrtillus (Vaccinium spp.). f289 Date Phoenix dactylifera. f291 Cauliflower Brassica oleracea var. botrytis. f292 Guava Psidium guajava. f293 Papaya Carica papaya. f294 Passion fruit, Maracuja Passiflora edulis (Passiflora spp.). f295 Carambola Averrhoa carambola. f296 Carob Ceratonia siliqua. f297 Gum Arabic Acacia senegal (Acacia spp.). f298 Tragacanth Astragalus spp. f299 Sweet chestnut (chestnut) Castanea sativa. f300 Pinto bean Phaseolus spp. f301 Persimmon (kaki fruit, sharon) Diospyros kaki. f302 Mandarin (tangerine, clementine, satsumas) Citrus reticulata. f305 Fenugreek Trigonella foenum-graecum. f306 Lime Citrus aurantifolia. f307 Hake Merluccius merluccius. f308 Sardine (pilchard) Sardina pilchardus. f310 Blue vetch Lathyrus sativus. f311 Megrim Lepidorhombus whiffiagonis. f315 Green bean Phaseolus vulgaris. f316 Rape seed Brassica napus. f317 Coriander Coriandrum sativum. f318 Jack fruit Artocarpus heterophyllus. f319 Beetroot Beta vulgaris. f320 Crayfish Astacus astacus. f321 Horse meat Equus caballus (Equus spp.). f322 Red currant Ribes sylvestre. f324 Hop (fruit cone) Humulus lupulus. f325 Saffron Colchicum autumnale. f328 Fig Ficus carica. f329 Watermelon Citrullus lanatus. f330 Rose hip Rosa spp. f331 Saffron Crocus sativus. f332 Mint Mentha piperita. f333 Linseed Linum usitatissimum. f336 Jujube Ziziphus jujuba. f336 Wine vinegar Vitis vinifera (Vitis spp.). f337 Sole Solea solea. f337 English sole Parophrys vetulus. f338 Wine, white Vitis vinifera (Vitis spp.). f339 Allspice Pimenta dioica. f339 Wine, red Vitis vinifera (Vitis spp.). f341 Cranberry Vaccinium oxycoccus ,Vaccinium macrocarpon. f342 Olive (black, fresh) Olea europaea. f343 Raspberry Rubus idaeus. f344 Sage Salvia officinalis. f346 Chives Allium schoenoprasum. f347 Quinoa Chenopodium quinoa. f348 Litchi Litchi chinensis. f349 Chum salmon roe Oncorhynchus keta. f358 Artichoke Cynara scolymus. f360 Yogurt NA. f368 Black bass Micropterus dolomieu (Micropterus dolomieui ). f374 Karaya gum Sterculia urens. f375 Horseradish Armoracia rusticana. f377 Maple syrup NA. f379 Okra Abelmoschus esculentus. f382 Beet, sugar Beta vulgaris var. altissima. f401 Loquat Eriobotrya japonica. f402 Fig Ficus carica. f403 Brewer's yeast Saccharomyces cerevisiae. f405 Mint Mentha spp. f406 Arugula Eruca vesicaria. House Dust h1 Greer Labs., Inc NA. h2 Hollister-Stier Labs NA. h6 Japan NA. Venoms & Insects i7 Midge Chironomus yoshimatsui. i8 Moth Bombyx mori ,Heterocera spp. i47 Water flea Daphnia spp. i49 Deer fly Chrysops spp. i51 Black ant Camponotus pennsylvanicus. i54 Flea mix (dog/cat), common flea Ctenocephalides spp. i71 Mosquito Aedes communis ,Aedes spp.and Culex spp. i72 Green nimitti Cladotanytarsus lewisi. i73 Blood worm Chironomus thummi ,Chironomusri parius ,Chironomus spp. i75 European hornet Vespa crabro. i76 Berlin beetle Trogoderma angustum. i77 European paper wasp Polistes dominulus. i78 Fly Musca domestica. i80 Bumblebee Bombus pennsylvanicus. i201 Horse bot fly Gasterophilus intestinalis. i202 Grain weevil Sitophilus granarius. i203 Mediterranean flour moth Ephestia kuehniella (Anagasta kuehniella ). i204 Horse fly Tabanus spp. i205 Bumblebee Bombus terrestris. i208 Api m 1.0101 Apis mellifera. a45 Api m 1 Apis mellifera. i209 Ves v 5.0101 Vespula vulgaris. a670 Ves v 5 Vespula vulgaris. i210 Pol d 5.0101 Polistes dominulus. i211 Ves v 1.0101 Vespula vulgaris. i213 Api m 4 Apis mellifera. i214 Api m 2 Apis mellifera. i215 Api m 3 Apis mellifera. i216 Api m 5 Apis mellifera. i217 Api m 10 Apis mellifera. i220 Bla g 1.0101 Blattella germanica. i221 Bla g 2.0101 Blattella germanica. i222 Bla g 5.0101 Blattella germanica. i223 Bla g 7 Blattella germanica. a46 Api m 2 Apis mellifera. Miscellaneous o1 Cotton, crude fibers Gossypium spp. o3 Cotton (treated) Gossypium spp. o70 Seminal fluid Homo sapiens. o71 Staphylococcus aureus Staphylococcus aureus. o72 Pichia pastoris crude extract customer specific Pichia pastoris. o72 Sperm-sediment Homo sapiens. o73 Pichia pastoris crude extr. vector customer specific Pichia pastoris. o74 Pichia pastoris with vector customer specific Pichia pastoris. o201 Tobacco leaf, tobacco dust Nicotiana tabacum. o202 Artemia salina, fish feed Artemia salina. o203 Tetramin, fish feed NA. o207 Daphnia, fish feed Daphnia spp. o211 Mealworm Tenebrio molitor. o212 Streptavidin Streptomyces avidini. o213 MBP (maltose binding protein) Escherichia coli. o214 CCD; MUXF3 from bromelain Ananas comosus. o72 Enterotoxin A (Sta a SEA) Staphylococcus aureus. o73 Enterotoxin B (Sta a SEB) Staphylococcus aureus. Parasites p1 Ascaris Ascaris suum. p2 Echinococcus Echinococcus granulosus. p3 Schistosoma Schistosoma mansoni. p4 Anisakis (Herring Worm) Anisakis simplex (Anisakis spp.). p5 Toxocara canis Toxocara canis. p10 Ani s 3.0101 Anisakis simplex (Anisakis spp.). p11 Ani s 1 Anisakis simplex (Anisakis spp.). Occupational k4 Threshing dust NA. k5 Flax NA. k7 Hay Dust NA. k8 Hop (hops) Humulus lupulus. k12 Grain mill dust NA. k14 Kapok NA. k20 Sheep's wool (treated) (wool) Ovis aries (Ovis spp.). k21 Sheep's wool (Untreated) Ovis aries (Ovis spp.). k23 Straw Dust NA. k33 Oak NA. k70 Green coffee bean Coffea spp. k71 Castor bean Ricinus communis. k72 Ispaghula Plantago psyllium/Plantago ovata. k73 Silk waste NA. k74 Silk Bombyx mori. k75 Isocyanate TDI (Toluene diisocyanate) NA. k76 Isocyanate MDI (Diphenylmethane diisocyanate) NA. k77 Isocyanate HDI (Hexamethylen diisocyanate) NA. k78 Ethylene oxide NA. k79 Phthalic anhydride NA. k80 Formaldehyde/Formalin NA. k81 Ficus Ficus benjamina (Ficus spp.). k83 Cotton seed Gossypium hirsutum. k84 Sunflower seed Helianthus annuus. k85 Chloramin T NA. k86 Trimellitic anhydride, TMA NA. k87 Asp o 21, alpha-amylase Aspergillus oryzae. k89 Orris root Iris florentina. k99 HSA (Human Serum Albumin) (Hom s HSA) Homo sapiens. k201 Car p 1, Papain Carica papaya. k202 Ana c 2, Bromelain Ananas comosus. k204 Maxatase Bacillus licheniformis. k205 Alcalase Bacillus spp. k206 Savinase, Protease 1 (Bac l Subtilisin) Bacillus spp. k208 Gal d 4, Lysozyme Gallus domesticus (Gallus gallus domesticus; Gallus spp.). k209 Hexahydrophtalic anhydrid NA. k210 Maleic anhydride NA. k211 Methyltetrahydrophtalic anhydrid NA. k212 Abachi wood dust Triplochiton scleroxylon. k213 Pepsin (Sus s Pepsin) Sus scrofa (Sus scrofa domesticus; Sus spp.). k213 TCPA NA. k214 Bougainvillea Bougainvillea spp. k225 Horse radish peroxidase (Arm r HRP) Armoracia rusticana. k226 Ascorbate oxidase (Cuc p ascorbate oxidase) Cucurbita pepo. k301 Flour dust Triticum spp. k501 Savinase customer specific Proprietary knowledge of customer. k502 Lipolase customer specific Proprietary knowledge of customer. k503 Termamyl customer specific Proprietary knowledge of customer. k504 Clazinase customer specific Proprietary knowledge of customer.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
August 3, 2022
Phadia AB % Tosha Dave Regulatory Affairs Specialist III Phadia US Inc 4169 Commercial Avenue Portage, Michigan 49002
Re: K212181
Trade/Device Name: ImmunoCAP Allergen f433, Allergen component rTri a 14 LTP, Wheat ImmunoCAP Allergen f416, Allergen component rTri a 19 Omega-5 Gliadin, Wheat ImmunoCAP Allergen f449, Allergen component rSes i 1 Sesame seed Regulation Number: 21 CFR 866.5750 Regulation Name: Radioallergosorbent (RAST) Immunological Test System Regulatory Class: Class II Product Code: DHB Dated: May 4, 2022 Received: May 5, 2022
Dear Sheryl Skinner:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
1
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Ying Mao, Ph.D. Branch Chief Division of Immunology and Hematology Devices OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Quality Center for Devices and Radiological Health
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Indications for Use
510(k) Number (if known) K212181
Device Name ImmunoCAP Specific IgE ImmunoCAP Allergen f433, Allergen component firi a 14 LTP, Wheat, ImmunoCAP Allergen component rTri a 19 Omega-5 Gliadin, Wheat and ImmunoCAP Allergen f449, Allergen component rSes i 1 Sesame seed
Indications for Use (Describe)
ImmunoCAP Specific IgE is an in vitro quantitative assay for the measurement of allergen specific IgE in human serum or plasma (EDTA or Na-Heparin). It is intended for in vitro diagnostic use as an aid in the clinical diagnosis of IgE mediated allergic disorders in conjunction with other clinical findings, and is to be used in clinical laboratories. ImmunoCAP Specific IgE is to be used with the instruments Phadia 1000, Phadia 2500 and Phadia 5000.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | --------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summary
This 510(k) Summary is prepared in accordance with the requirements of 21 CFR Part 807.92.
Premarket Notification 510(k) No: K212181
| Date of Summary Preparation: | June 28, 2022 |
|---|---|
| Manufacturer: | Phadia AB |
| Rapsgatan 7P | |
| P.O. Box 6460 | |
| 751 37 Uppsala, Sweden | |
| Distributor: | Phadia US Inc. |
| 4169 Commercial Avenue | |
| Portage, MI 49002 | |
| Company Contact Person: | Jane Anthony |
| Sr. Manager, Quality Systems and Compliance | |
| Phadia US Inc. | |
| 4169 Commercial Avenue | |
| (269) 254-6833 | |
| Jane.anthony@thermofisher.com |
Device Name:
ImmunoCAP Specific IgE
- -ImmunoCAP Allergen f433, Allergen Component rTri a 14 LTP, Wheat
- ImmunoCAP Allergen f416, Allergen Component rTri a 19 Omega-5 Gliadin, Wheat -
- ImmunoCAP Allergen f449, Allergen Component rSes i 1, Sesame seed -
Purpose for Submission:
This submission is for the clearance of three new ImmunoCAP Allergen Components to be added to the previously cleared ImmunoCAP Allergen Specific IgE assay system.
The addition of the new ImmunoCAP Allergen Components does not affect the Intended Use or the Indications for Use. The previously cleared system may be referenced under K051218.
Measurand:
Allergen specific IgE
4
Type of Test:
Fluoroenzymeimmunoassay, Ouantitative
Common Name:
Automated in-vitro quantitative assay for the measurement of allergen specific IgE antibodies.
Regulatory Information:
| Product Code | DHB |
|---|---|
| Class | II |
| CFR | 866.5750 - Radioallergosorbent immunological test |
| system (RAST) | |
| Panel | Immunology (82) |
Intended use:
ImmunoCAP Specific IgE is an in-vitro quantitative assay for the measurement of allergen specific IgE in human serum or plasma (EDTA or Na-Heparin). It is intended for in-vitro diagnostic use as an aid in the clinical diagnosis of IgE mediated allergic disorders in conjunction with other clinical findings and is to be used in clinical laboratories. ImmunoCAP Specific IgE is to be used with instruments Phadia 1000, Phadia 2500 and Phadia 5000.
Indications For Use Statement:
Same as intended use.
Special Conditions for Use:
Rx - For Prescription Use Only.
Special instrument requirements:
For use on the instruments Phadia 250, Phadia 1000, Phadia 2500 and Phadia 5000.
Device Description:
Reagents
ImmunoCAP Specific IgE reagents are modular in concept and are available individually. For a complete listing of reagents needed to perform the Phadia ImmunoCAP Specific IgE assay, please consult the ImmunoCAP Specific IgE Conjugate Directions for Use.
Instrument System
Phadia 250, Phadia 1000, Phadia 2500 and Phadia 5000 instrument systems, and associated software, processes all steps of the assay and calculates results automatically after the assay is completed. Analytical and clinical validation of these components were performed on the representative instrument Phadia 250 and Phadia 1000.
5
ImmunoCAP Specific IgE, Test Principle
The allergen of interest, covalently coupled to ImmunoCAP, reacts with the specific IgE in the patient sample. After washing away non-specific IgE, enzyme labeled antibodies against IgE are added to form a complex. After incubation, unbound enzyme anti-IgE is washed away, and the bound complex is then incubated with a developing agent. After stopping the reaction, the fluorescence of the eluate is measured. The higher the response value, the more specific IgE is present in the specimen. To evaluate the test results, the responses for the patient samples are transformed to concentrations with the use of a calibration curve.
Substantial Equivalence to:
K051218
ImmunoCAP Specific IgE
- ImmunoCAP Allergen f4, Wheat (14-4113-01) -
- -ImmunoCAP Allergen f10, Sesame (14-4175-01)
Comparison with predicate:
| Proposed Device | Predicate Device | |
|---|---|---|
| ImmunoCAP Allergen | ||
| Components | ImmunoCAP Specific IgE | |
| (formally UniCAP Specific IgE) (K051218) | ||
| Similarities | ||
| Classification | Class II | Class II |
| Product Code | DHF | DHF |
| Regulation Number | 866.5750 | 866.5750 |
| Intended | ||
| Use/Indication for | ||
| Use | ImmunoCAP Specific IgE is | |
| an in vitro quantitative assay | ||
| for the measurement of | ||
| allergen specific IgE in | ||
| human serum or plasma | ||
| (EDTA or Na-Heparin). It is | ||
| intended for in vitro | ||
| diagnostic use as an aid in the | ||
| clinical diagnosis of IgE | ||
| mediated allergic disorders in | ||
| conjunction with other | ||
| clinical findings and is to be | ||
| used in clinical laboratories. | ||
| ImmunoCAP Specific IgE is | ||
| to be used with the | ||
| instrument Phadia 250, | ||
| Phadia 1000, Phadia | ||
| 2500 and Phadia 5000. | UniCAP Specific IgE is an in | |
| vitro semi-quantitative assay | ||
| for the measurement of | ||
| allergen specific IgE in | ||
| human serum or plasma. It | ||
| is intended for in vitro | ||
| diagnostic use as an aid in | ||
| the clinical diagnosis of IgE | ||
| mediated allergic disorders | ||
| in conjunction with other | ||
| clinical findings, and is to be | ||
| used in | ||
| clinical laboratories, as well | ||
| as physician office | ||
| laboratories. | ||
| Analyte | Specific IgE | Specific IgE |
| Type of test | Fluoroenzymeimmunoassay | Fluoroenzymeimmunoassay |
| Method | Sandwich immunoassay | Sandwich immunoassay |
| Assay Type | Quantitative | Quantitative |
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| Sample Type | Human serum or plasma
(EDTA or Na-Heparin) | Human serum or plasma
(EDTA or Na-Heparin) |
|-----------------------------------------------------------------|-------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------|
| Assay system reagents | ImmunoCAP Specific IgE
Calibrators, Conjugate and
Controls | ImmunoCAP Specific IgE
Calibrators, Conjugate and
Controls |
| Technology | Immunofluorescence | Immunofluorescence |
| Software | ImmunoCAP Specific IgE
method in Phadia
Information Data Manager
(IDM) or Phadia Prime | ImmunoCAP Specific IgE
method in Phadia
Information Data Manager
(IDM) or Phadia Prime |
| Reporting of results | Quantitative, kUA/L | Quantitative, kUA/L |
| Analytical sensitivity
(LoD/LoQ) | 0.1 kUA/L | 0.1 kUA/L |
| Differences | | |
| Allergen raw material
coupled to
ImmunoCAP solid
phase | Individual recombinant
allergen component | Extract based allergen
comprising of multiple protein
components from the allergen
source component |
Standard/Guidance Document Referenced:
EP25-A, CLSI, 2009, Evaluation of Stability of In Vitro Diagnostic reagents
CLSI EP05-A3: Evaluation of Precision of Quantitative Measurement Procedures; Approved Guideline - Third Edition
I/LA20: Analytical Performance Characteristics, Quality Assurance, and Clinical Utility of Immunological Assays for Human Immunoglobulin E Antibodies of Defined Allergen Specificities, 3rd Edition
CLSI EP07-A2: Interference testing in Clinical Chemistry; Approved Guideline - Second Edition.
CLSI EP07 3rd Edition: Interference Testing in Clinical Chemistry.
CLSI EP17-A2: Evaluation of Detection Capability for Clinical Laboratory Measurement Procedures; Approved Guideline - Second Edition
CLSI EP39, 1st Edition, 2021, A Hierarchical Approach to Selecting Surrogate Samples for the Evaluation of In Vitro Medical Laboratory
Performance Characteristics
The new ImmunoCAP Allergen Components were compared to the extract based predicate device. Positive clinical samples (atopic) and samples from healthy, non-atopic donors were
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studied. Analytical performance characteristics for the new ImmunoCAP Allergen Components were established by Precision/reproducibility, Limit of Detection, and Stability studies. Inhibition studies verified the analytical specificity of the allergen components.
Precision/Reproducibility
i. Within-laboratory imprecision
Imprecision of each ImmunoCAP Allergen Component was evaluated by testing five (f433, rTri a 14) or six (f416, rTri a 19 and f449, rSes i 1) positive-samples (> 0.1 kUx/L) with concentrations of allergen specific IgE spanning the analytical measuring range (AMR). Each sample was tested in four replicates in one assay run per day for a total of 20 operating days (a total of 80 replicates per sample) except Sample 6 for f416, rTri a 19 that was tested in three replicates in 11 runs over 20 days (a total of 33 replicates). One (1) lot of each ImmunoCAP Allergen component was tested with each sample. The assay was performed according to the ImmunoCAP Specific IgE Directions for Use using a Phadia 250. Mean concentrations of allergen specific IgE, standard deviation (SD), and coefficients of variance (%CV) were calculated for each sample, separately. Results are shown in the table 1 below:
| ImmunoCAP
Allergen
Component | Sample
N | Mean
(kUA/L) | Within-run
(Repeatability) | | Between-run
(Repeatability) | | Total
(Within-
Laboratory) | | |
|--------------------------------------------------|-------------|-----------------|-------------------------------|------|--------------------------------|------|----------------------------------|------|-------|
| | | | SD | %CV | SD | %CV | SD | %CV | |
| f433, rTri a 14
LTP (Wheat) | 1 | 80 | 0.18 | 0.01 | 6.05 | 0.01 | 6.10 | 0.02 | 8.59 |
| | 2 | 80 | 0.34 | 0.03 | 7.43 | 0.02 | 7.14 | 0.03 | 10.30 |
| | 3 | 80 | 2.24 | 0.08 | 3.35 | 0.10 | 4.41 | 0.12 | 5.53 |
| | 4 | 80 | 14.83 | 0.48 | 3.27 | 0.70 | 4.75 | 0.85 | 5.76 |
| | 5 | 80 | 82.81 | 4.91 | 5.93 | 5.20 | 6.27 | 7.15 | 8.63 |
| f416, rTri a 19
Omega-5
Gliadin
(Wheat) | 1 | 80 | 0.15 | 0.01 | 8.88 | 0.01 | 6.63 | 0.02 | 11.09 |
| | 2 | 80 | 0.28 | 0.02 | 6.47 | 0.01 | 4.94 | 0.02 | 8.14 |
| | 3 | 80 | 2.72 | 0.09 | 3.20 | 0.08 | 3.06 | 0.12 | 4.42 |
| | 4 | 80 | 18.49 | 0.53 | 2.86 | 0.96 | 5.17 | 1.09 | 5.91 |
| | 5 | 80 | 37.50 | 1.00 | 2.66 | 2.05 | 5.46 | 2.28 | 6.08 |
| | 6 | 33 | 71.52 | 5.56 | 7.77 | 3.16 | 4.42 | 6.40 | 8.95 |
| f449, rSes i 1
(Sesame seed) | 1 | 80 | 0.16 | 0.01 | 7.22 | 0.01 | 5.42 | 0.01 | 9.03 |
| | 2 | 80 | 0.35 | 0.01 | 2.43 | 0.01 | 2.36 | 0.01 | 3.39 |
| | 3 | 80 | 2.23 | 0.06 | 2.59 | 0.04 | 1.69 | 0.07 | 3.09 |
| | 4 | 80 | 14.27 | 0.38 | 2.68 | 0.22 | 1.53 | 0.44 | 3.09 |
| | 5 | 80 | 56.25 | 2.58 | 4.59 | 2.06 | 3.67 | 3.30 | 5.87 |
| | 6 | 80 | 71.85 | 4.95 | 6.89 | 2.48 | 3.45 | 5.53 | 7.70 |
Table 1: Within-Laboratory imprecision
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ii. Lot-to-lot imprecision
Three different lots of each ImmunoCAP Allergen Component: f433, rTri a 14 LTP (Wheat); f416, rTri a 19 Omega-5 Gliadin (Wheat); and f449, rSes i 1 (Sesame seed) were tested using four (f433, rTri a 14 and f416, rTri a 19) or five (f449, rSes i 1) positive samples and one negative sample ( 50% inhibition to show analytical specificity.
Testing was performed with the respective ImmunoCAP Allergen component on the Phadia 250 according to the ImmunoCAP Specific IgE, Directions for Use. Mean values and % Inhibition were calculated.
The three unrelated control inhibitors and the one related control inhibitor for each ImmunoCAP Allergen component, are shown in table 11 below.
| ImmunoCAP Allergen
| Component | Unrelated inhibitors |
|---|---|
| f433, rTri a 14 LTP Wheat | Unrelated: rFel d 2, rOle e 1 and rVes v 5 |
| Related: rAra h 6 | |
| f416, rTri a 19 Omega-5 | |
| Gliadin Wheat | Unrelated: rCan f 4, rVes v 5 and rAsp f 1 |
| Related: rPru p 1 | |
| f449, rSes i 1 Sesame seed | Unrelated: rCan f 4, rAsp f 1 and rOle e 1, |
| Related: rCor a 8 |
Table 11: unrelated inhibitors for allergen components
All results met the specifications and analytical specificity for the ImmunoCAP Allergen Components rTri a 19, Wheat (f416); rTri a 14, Wheat (f433); and Ses i 1, Sesame (f449), was verified.
Interference
Endogenous Substance Interference:
A study was conducted to evaluate if icteric, haemolytic or lipemic samples, or samples containing Rheumatoid Factor, can adversely affect the results of the ImmunoCAP Allergen components rTri a 19, Wheat (f416); rTri a 14, Wheat (f433); and Ses i 1, Sesame (f449) in the ImmunoCAP Specific IgE assay.
Three samples (two positive and one negative) were spiked with Bilirubin F, Bilirubin C, Chyle, Hemoglobin and Rheumatoid Factor. The spiked samples were tested with one (1)
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lot of each ImmunoCAP Allergen component to evaluate assay interference. The results demonstrate that icteric, hemolytic or lipemic samples do not adversely affect the results in ImmunoCAP Specific IgE assay using ImmunoCAP Allergen components rTri a 19, Wheat (f416); rTri a 14, Wheat (f433); and Ses i 1, Sesame (f449). In addition, the results show that Rheumatoid Factor do not adversely affect the results in the evaluated assays. Concentrations of interferent that can be tolerated are shown in table 12 below.
| Interferant | Tolerated concentration | ||
|---|---|---|---|
| rTri a 14 | rTri a 19 | rSes i 1 | |
| Bilirubin F (mg/dL) | 18.5 | 18.6 | 39.8 |
| Bilirubin C (mg/dL) | 20.8 | 20.2 | 42.2 |
| Chyle (FTU) | 1640 | 1630 | 16300 |
| Hemoglobin (mg/dL) | 490 | 490 | 500 |
| Rheumatoid Factor (IU/mL) | 500 | 550 | 550 |
Table 12: Interference study results, tolerated concentrations of Endogenous interferants
Stability studies
Stability studies were performed in accordance with CLSI EP25-A using three lots of each ImmunoCAP Allergen component. The real-time stability study for ImmunoCAP Allergen components rTri a 19 Omega-5 Gliadin, Wheat (f416); rTri a 14 LTP, Wheat (f433), met the specifications and showed 19 months unopened shelf-life stability.
The real-time stability data for ImmunoCAP Allergen component rSes i 1 (f449), supports unopened shelf-life stability of 6 months. The real-time stability study is ongoing for Allergen component rSes i 1 (f449). An accelerated stability study was performed with two positive and one negative samples and three lots of ImmunoCAP Allergen component rSes i 1 (f449). The accelerated stability data supports the claim of 6 months unopened shelf-life stability for f449, rSes i 1 (Sesame seed).
Method Comparison study
To demonstrate the relationship between specific IgE antibodies to ImmunoCAP Allergen component and the corresponding extract based ImmunoCAP Allergen (predicate device), 43-62 selected samples from; (i) individuals with a clinical history of allergy-like symptoms upon exposure to the allergen (32-33 positive clinical samples), (ii) samples from sensitized individuals without documented clinical history (10-30 positive non-clinical samples), and (iii) samples from healthy non-atopic donors with no history of allergy (100 negative samples) were used.
For all three components undetectable levels of specific IgE antibodies ( 0.1 kUx/L were demonstrated in 32/32 clinical samples and 30/30 non-clinical samples when analyzed with ImmunoCAP Allergen f449, rSes i 1.
Clinical studies
Clinical sensitivity and specificity:
The performance of each ImmunoCAP Allergen Component rTri a 14, Wheat (f433); rTri a 19, Wheat (f416) and Ses i 1, Sesame (f449) was compared to a clinical diagnosis of allergy. The objective of this study was to show the agreement between the specific IgE antibodies to ImmunoCAP Allergen component and clinical diagnosis to wheat, using clinical samples. Selected samples from individuals with a clinical history of allergy-like symptoms upon exposure to wheat, as diagnosed by a physician and samples from healthy subjects with no reported clinical reaction to the allergen (non-atopic subjects; n=100) were used in the study. The samples were tested with the ImmunoCAP Allergen component using one replicate in the ImmunoCAP Specific IgE assay. Clinical sensitivity and specificity in this sample cohort are summarized in the tables 13, 14 and 15. Test results ≥0.35 kUA/L are considered positive.
| ImmunoCAP
| Allergen Component | Clinical Diagnosis to Wheat | |||
|---|---|---|---|---|
| Atopic | Non-atopic | Total | ||
| f433, | ||||
| rTri a 14 | Positive | 25 | 0 | 25 |
| Negative | 108 | 100 | 208 | |
| Total | 133 | 100 | 233 |
Sensitivity = 19 % (25/133) 95% CI: 12.5%-26.5%
Specificity =100% (100/100) 95% CI: 96.4%-100%
Table 13:Clinical Sensitivity and Specificity - Allergen Component f433, rTri a 14 LTP, Wheat
| ImmunoCAP
| Allergen Component | Clinical Diagnosis to Wheat | |||
|---|---|---|---|---|
| Atopic | Non-atopic | Total | ||
| f416, | ||||
| rTri a 19 | Positive | 41 | 0 | 41 |
| Negative | 88 | 100 | 188 | |
| Total | 129 | 100 | 229 |
Sensitivity = 32 % (41/129) 95% CI: 23.9 - 40.6%
Specificity = 100% (100/100) 95% CI: 96.4%-100%
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Table 14:Clinical Sensitivity and Specificity - Allergen Component, f416, rTri a 19 Omega-5 Gliadin, Wheat
| ImmunoCAP
| Allergen Component | Clinical Diagnosis to Sesame | |||
|---|---|---|---|---|
| Atopic | Non-atopic | Total | ||
| f449, | ||||
| rSes i 1 | Positive | 28 | 0 | 28 |
| Negative | 7 | 100 | 107 | |
| Total | 35 | 100 | 135 |
Sensitivity = 80% (28/35) 95% CI: 63.1 - 91.6% Specificity =100% (100/100) 95% CI: 96.4%-100%
Table 15:Clinical Sensitivity and Specificity - Allergen Component, f449, rSes i 1, Sesame Seed
Conclusion
The safety and effectiveness of the cleared device ImmunoCAP Specific IgE for the determination of specific IgE antibodies have been established in previous 510(k) submissions. This submission covers the addition of three new ImmunoCAP Allergen Component to the existing ImmunoCAP Specific IgE assay. The addition of the new ImmunoCAP Allergen Components does not affect the Intended Use / Indications for Use Statements.